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A CROSS-SECTIONAL STUDY OF ABNORMAL ADJUSTED -BODY MASS INDEX AMONG LOWER

LIMB AMPUTEES IN UERMMMCI PSPO-CTC IN RELATION TO THEIR FALLS RISKS

A Thesis Presented to the Faculty of


The College of Allied Rehabilitation Sciences
University of the East Ramon Magsaysay
Memorial Medical Center

In Partial Fulfillment of the Requirements for the Degree of


Bachelor of Science and Physical Therapy and
Bachelor in Prosthetics and Orthotics

MARK ANGEL A.D. CASTILLO

AIDAN LLOYD CRUCIS

CHANNELLE M. ELLIMA

ESABELLE ALLYANA G. GO

JEREMIE RAKIEL V. MARANAN

ALEXANDRENE DANIELLE O. MERIN

MARIE KATRINA A. MONTEVERDE

EPHRAIM MARTIN M. NOVILLA

Christian Gabriel Lee, PTRP

Japhet Gerard V. Regidor, CPO

Thesis Advisers

August 2018
TABLE OF CONTENTS
Chapter 1: Introduction .................................................................................................................................
Background of the Study .............................................................................................................................
Review of Related Literature........................................................................................................................
Research Objectives....................................................................................................................................
Significance of the Study .............................................................................................................................
Hypothesis ...................................................................................................................................................
Scope and Limitations .................................................................................................................................
Operational Definition of Terms ...................................................................................................................
Chapter 2: Methodology................................................................................................................................
Research Setting .........................................................................................................................................
Research Design .........................................................................................................................................
Sampling......................................................................................................................................................
Instrumentation ............................................................................................................................................
Data Gathering Procedure ...........................................................................................................................
Inclusion and Exclusion Criteria ...................................................................................................................
Statistical Analysis .......................................................................................................................................
Ethical Consideration ...................................................................................................................................
Chapter 3: Dummy Results ...........................................................................................................................
Text..............................................................................................................................................................
Chapter 1

INTRODUCTION

This chapter presents the background of the study, research objectives, research question,

hypotheses, significance of the study, the scope and limitation of the study and operational definition of

terms.

Background of the Study:

The Body Mass Index (BMI) was developed to assess an individual’s body composition status. It is

calculated from body weight by height and is used as a screening tool to identify whether a person is

underweight, overweight, obese, or on a healthy weight for their height. BMI is calculated the same way for

both adults and children, with the use of metric system, the formula for BMI is weight in kilograms divided

by height in meters squared. The standard weight status categories associated with BMI ranges for adults,

below 18.5 is considered underweight, 18.5-24.9 as normal or healthy weight, 25.0-29.9 is overweight and

30.0 and above is considered as obese[1].

Variations in BMI with adjusted self-report measures do provide estimates of health risks for

developing certain diseases like breathing problems, hypertension, cancer[2] , and used to predict the odds

of having ever been diagnosed with diabetes and an increase in BMI would equate to detrimental effects on

one’s overall health and mortality, but that is not always the case – people with below normal BMI have a

higher mortality rate compared to people with above normal BMI [3]. Both above normal and below normal

BMI must be considered as factors in contributing to one’s health risks[4].


Often vulnerable in this kind of changes in BMI are the lower limb amputees (LLA)[5]. LLAs have

different levels of amputation from distal to proximal including partial foot, ankle disarticulation, transtibial

knee disarticulation, transfemoral, hip disarticulation and hemipelvectomy. In Philippines, the Philippines

School of Prosthetics and Orthotics (PSPO) charity clinic caters great numbers of amputees in the

countries starting from pre-prosthetic training, prosthetic fitting, gait training until follow-up. Majority of them

are transtibial and transfemoral amputation having a ___% and ___% of the total number of its clients

respectively. Relatively, the relationship between level of amputation and BMI was established wherein

there is approximately an increase of 3% - 6% in BMI of men with a partial foot amputation, and an 8 – 9%

increase in BMI of men with transtibial or transfemoral amputation[5].

Calculation of Body Mass Index of amputees would be different from the Body Mass Index of a

normal person. The standard BMI was compared with the A-BMI (adjusted BMI for amputees), and it

showed that the standard BMI tends to underestimate the weight classification of amputees – amputees

who are “overweight” using the standard BMI are actually under the “obese I” category using the A-BMI,

which makes the values of the standard BMI consistently lesser[6]. The software, Amputee Coalition Web-

based Calculator, was used to calculate the A-BMI. The software was done by the same organization

(Amputee Coalition of America) whom formulated the adjusted formula of BMI for amputees.

Lower limb amputees are at great risk for falls than older adult inpatients[6], thereby taking into

consideration the effect from increased risk, gives rise to the fear of falling which restricts the individual to

do ones ADLs. The factors affecting the risk for falls in LLAs are shared with the general population of older

adults include lower extremity muscle weakness, increasing age, comorbidities, and number of prescription

medications[7]. Dysvascular cause of the amputation, postoperative transtibial amputation, post

rehabilitation transfemoral amputation and decreased sense of vibration are risk factors for falls that are

unique to adults with LLA[7]. Falls in adults with LLA are common from the time of the amputation to year
later living in the community[7], thereby factors affecting the risk for falls vary across care settings after the

amputation, which has implications for safety.

Although several studies have been able to determine the relationship of above & below normal

BMI and falls risks among non-amputees[6][8], none have been made among LLA specifically among the

transtibial & transfemoral amputees, especially in the Philippine setting. Therefore, the primary purpose of

this study will be to determine the prevalence of the abnormal BMI among transtibial and transfemoral

amputees in UERMMMCI PSPO CTC clinic. Secondarily, the researchers will look into the possible relation

of LLAs’ BMI and to their risk of fall.

REVIEW OF RELATED LITERATURE

Health Risks of Abnormal BMI

In the study of Jahangir et al[4], the researchers reviewed the effects of Low weight and

overweightness among older adults in all-cause mortality and other medical comorbidities. As the

researchers reviewed the study of Flegal et al on the effects of Obesity and all-cause mortality among 65

years and older being overweight has decreased risk of all-cause mortality compared to normal weight.

Another systematic review showed that BMI in overweight range are not associated with increase mortality

risk. On the other side on low weight and mortality the researchers suggested that low weight on elderly is

associated with poor nutritional status, which may lead to decline in their functional status and survival.

Also, low weight in elderly was associated with osteoporosis, risk of malnutrition and traumatic accidents

that may lead to bone fractures that can also lead to morbidity and mortality. Therefore, the researchers

concluded that having the ideal amount of body fat and preserving lean body mass is important to prevent
increased morbidity and mortality among older adults, and having a proper physical exercise and healthy

diet and behavioral therapy will able older adults to maintain their weight.

The study conducted by Stommel & Schoenborn[2] assessed the inaccuracy present in BMI

measures that are based on self-reported height and weight (self-reported BMI) compared with BMI

measures based on physical measurement of height and weight (measured BMI) to understand the

limitations of using the self-reported measures. Out of the total sample, 17,176 adults, 15,662 (91.2%) had

measured BMI and 16,579 (96.5%) had self-reported BMI. Results showed that self-reported heights

represents a moderate overestimate of one centimeter, while self-reported weight represents an

underestimate of measured weight by 3/4 of a kilogram. The weight discrepancies indicate overestimates of

self-reported weight in lower BMI categories and underestimates of self-reported weight in the higher BMI

categories. The net result is a linear trend towards declining self-reported BMI values relative to measured

BMI values and from five logistic regression model (gender, age, education, race/ethnicity and household

income) BMI measures can be used to predict the odds of having ever been diagnosed with diabetes. The

researchers concluded that BMI values based on self-reported height and weight remain an important tool

for population-based estimates of the health risks involved in obesity and BMI values, if corrected based on

self-reported height and weight can be associated with socio-demographic characteristics of the survey

respondents and can be used to provide accurate estimates of the proportion of overweight members of the

population.

The study conducted by Kvamme et al in 2011[3] determined the association of BMI and mortality of

7604 men and women who participated in the Tromso and HUNT study from 1994 – 1997. Tromso and

North Trondelag are both towns located in Norway. Out of 7604 subjects, there were 7474 deaths during a

mean follow-up of 9.3 yrs. The causes of death were determined using the International Classification of

Diseases (ICD) system, and found out the 3 main causes of death – CVD, respiratory diseases, and
cancer. The subjects were classified according to their BMI. The BMI category (25.0 – 27.4) with the most

subjects and deaths was used as a reference. They found out that mortality increases when BMI falls,

especially below the range of 19 – 23. There was a 20% increase in mortality per 2.5 kg/m2 decrease in

BMI in the lower BMI range. Subjects with a BMI of 25.0 – 29.9 had the lowest mortality. The main cause of

mortality for the subjects in the lower BMI range was respiratory diseases, particularly asthma and chronic

bronchitis, which accounts for the 40% mortality in men and 17% mortality in women. The researchers were

concerned with reverse causation – a pre-existing illness may have contributed to their lower BMI and

mortality; to overcome this, they excluded subjects whom died during the first year of follow-up, subjects

with a history of cancer, and the mortality from subjects with asthma/chronic bronchitis was compared. It

was found that the exclusion and comparison didn’t affect the relationship of mortality and low BMI. Other

factors that may had contributed to the mortality of subjects with low BMI was the loss of periphery and

respiratory muscles, and their vulnerability to acute diseases.

The study conducted by Freedman et al[1] determined the authenticity of the Slaughter skinfold

thickness equations, at predicting levels of percentage body fat determined by using dual-energy X-ray

absorptiometry (DXA; PBFDXA) which were based on sex, maturation, and skinfold thicknesses, among

1196 respondent children & adolescents. The study also examined whether BMI was less likely associated

with levels of cardiovascular disease risk factors than percentage body fat estimated by using the Slaughter

skinfold-thickness equations in 6725 children and adolescents 5–17 y/o. Weight guidelines provided by the

manufacturer were chosen and followed for scan mode and each scan provided an estimate of PBFDXA

while caliper were used to measure skinfold thicknesses on the right side of the body, three times to the

nearest 1.0 m. Results showed that there was small difference by using PBFDXA indicating body fatness

being more strongly associated with CVD risk factors than BMI. Body fatness by skinfold thickness showed

greater correlation to body fatness among non-obese however it overestimates among those obese
children and has little more effectiveness over sex- and age-adjusted BMIs in children & adolescents with

increased risk of CVD.

Amputees and Falls Risks

In the systematic review of Hunter, S. et al[7], there were twelve studies that qualified the inclusion

criteria. Searches of electronic databases were conducted in MEDLINE, CINAHL, EMBASE and PubMed

which covers databases from January 1988 to January 2016. The studies included were non-interventional

studies, cohort, and cross-sectional studies. It was stated that the risk factors increasing falls were lower

extremity muscle weakness, increasing age, co-morbidities, and the number of prescription medications.

However, there were risk factors for falls that are unique to LE amputees such as dysvascular etiology of

the amputation, transtibial and transfemoral level post-rehabilitation, and reduced sense of vibration. This

study covered the acute hospital after amputation, inpatient rehabilitation and community living. It stated

that the occurrence of falls in acute hospital is 20.8% up to 58% in the community years after amputation.

A systematic review done by Steinberg et al[8] reviewed several studies about the factors that may

affect lower limb amputees’ risk for falls. To make it more comprehensible, the incidence of falls in the

studies was classified as the following: (1) during their stay in the surgical ward, (2) during inpatient

rehabilitation, and (3) during community living. For amputees in the surgical ward, their risk factors were

based more on the etiology and level of amputation: dysvascular etiology, and right-sided amputations and

TTA amputations. For inpatients, geriatrics had a higher risk for falls. This may be associated with their

several comorbidities and/or polypharmacy; some had a cognitive impairment, which increased their risks

for falls. For amputees living in their community, level of amputation was still a large factor – TTA having a

higher factor than TFA. Surprisingly, amputees who have better balance ability are more prone to falls. This

is due to amputees who have poorer balance ability or who’ve had prosthetics for a short while fear falls,
thus, their tendency is to stay put and not move so much; while amputees who have a better balance ability

are less cautious. In addition to being less cautious, they have a weaker knee joint musculature on their

prosthetic limb and their gait greatly differs from non-amputees, especially in their step regularity. Poor

vibration sense is also a major factor, increasing their risks to up to three times.

A prospective cohort study was conducted by Wong et al[9] which assessed lower limb amputees’

risks for falls leading to injuries. The total number of participants was 41, all of whom were community-

dwellers with bilateral or unilateral lower limb amputation of any etiology or level of amputation. Amputees

with health issues that affected their balance (e.g. stroke, vestibular diseases, etc.) were excluded. 6.7 was

the mean time since their amputation, ranging from 0 – 46 years. The researchers based their main

outcome measures through self-reported falls from the participants. Houghton scale was used in order to

determine their prosthetic use for mobility. Berg Balance Scale was used after to determine their balance

ability. Three main factors were concluded to be the major contributors to the risks for falls: (1) Vascular

amputation, (2) Sex, and (3) Age. Amputees with vascular etiology have coexisting health issues,

especially diabetes or diabetes-related diseases, which affects their risks for falls. Females were also found

to have a higher risk for falls; their injury rate reached to 5.88 times greater than males. They are more

prone to fractures in the lumbar spine, pelvis, and hip. Their falls occurring mostly while in the bathroom. As

age increases, the risk for falls also increases. Their rate for hospitalization due to injuries from falls is

greater. However, age was not an independent variable and was merely a mediator, for the increase in age

was associated more with a decrease in health which affects falls risks more. An increase in health risks

may lead to a decrease in activity, which discourages amputees to move more, thus, decreasing their

opportunities for falls. By the end of the study, there were 23 out of 41 (56.1%) subjects who reported at

least a single fall, while 11 out of 41 subjects (26.8%) reported a fall-related injury. More than half of the 41

subjects had reported at least one incident of fall in the span of 12 months in both groups (injured and

uninjured). In the unsatisfied prosthetic users, 72.7% had a fall incident as compared to 50% of satisfactory
prosthetic users. Out of all the participants, 43.9% did not had any falls incidents while 29.3% of the

participants experienced repeated falls. Stated in this study were those who had recurrent falls had a higher

risk of having severe injuries.

According to the study of Barnett et al[10], changes in indices of falls efficacy were correspondingly

related to both the physical and mental health suggesting that an increase in either or both of these aspects

of health may improve the falls efficacy over time. Changes in the general falls efficacy are being reflected

by the changes seen in the falls efficacy of both indoor activities (factor one) and outdoor activities (factor

two). However, many of the changes were not statistically significant due to the small sample size of the

study. The objectives of this study were to examine the changes in falls efficacy of unilateral transtibial

amputees with the use of Modified Falls Efficacy Scale, and to determine the correlation between falls

efficacy and indices of QOL (factors of SF36). The participants of the study were seven male unilateral

below-knee amputees (at least 18 years old) who had completed the amputee rehabilitation 4 weeks before

they agreed to be part of the study. These participants were initially approached by the physiotherapy team

and were asked if they could be contacted by the principal investigator.

In the 2014 study of Hordacre et al[11], forty-seven transtibial amputees from a metropolitan

prosthetic service in Adelaide, South Australia participated in this study. Primarily, they were males (79%)

whose ages were ranging from 19-98 years old, but with the average of 59.7 years and 16.2 years of

amputation. Accelerator motor device and GPS device were provided to the participants in order to record

their activity and participation information for seven days consecutively. In the following 12 months, sixteen

of the participants were reported to have falls experiences. There was no substantial difference among the

fallers and non-fallers in terms of age, gender, indication of amputation, time since amputation, K-level,

AMP-PRO score, and even the stump length (all p>0.08); in their activity roles in work, residential, health,
social and home setting (all p>0.16). However, there was a reported substantial difference in the

recreational participation and total community participation between the fallers and non-fallers.

In the cross-sectional study of Wong et al[12], there were sixty subjects in the study however, only

fifty-four subjects attended and completed the assessment. Assessments used were Houghston Scale of

prosthetic functional use, Activities-specific Balance Confidence scale, and the Berg Balance Scale. There

were eleven trained clinicians who assessed the balance ability of the participants. These clinicians

demonstrated excellent inter-rater reliability with regards to determining Berg Balance Scale for lower limb

amputees. The testing was done within less than fifteen minutes. The subjects were categorized by

experience of falls in the past years and the balance ability strata. Out of the fifty-four subjects, those who

experienced falls were 53.7%, while those who experienced recurrent falls were 25.9%. In the stratum of

balance ability, there were 31.5% in the lowest stratum, 27.8% in stratum II, 16.7% and 24.1% in the

highest ability strata. It was stated in the analysis of fall categories and balance strata, those who had

greater a BMI reported falls; those who reported recurrent falls had a higher mean in total of the BBS

scores of 48.4 in comparison to those who had not; those who had lower odds of falling had higher

confidence in balance. Subjects who had greater risks of falling were those with a higher BMI.

Amputees and BMI

Littman et al[5] conducted a retrospective cohort study to identify the weight changes in men with

amputation and men without amputation. There were 3,7960 men without amputation and 759 men with

amputation. Three levels of amputation were included: partial foot amputation (396 males), transtibial

amputation (267 males), and transfemoral amputation (96 males). The data were obtained from the

Department of Veterans Affairs (VA) Northwest Region database (Veterans Integrated Service Network

[VISN]). The weight change from the baseline up to the 39-month of follow-up was compared in men with

and without amputation. It was found that weight gain in men with amputation was significantly greater in
the first 2 years after amputation than men without amputation. There was an 8-9% increase in men with

TTA or TFA, and a 3-6% increase in men with a PFA. The weight gained during the first 2 years of

amputation was associated with a decrease in activity, overeating, and/or sedentary lifestyle. There were

several reasons behind these – wound healing process may take weeks or months, which made them

unmotivated and inactive; it may take up to approximately 12 months before they could obtain a properly

fitting prosthesis, which also decreased their level of activity; depression is also highly prevalent among

amputees, which may had contributed to their inactivity and overeating. Excess weight gain in lower limb

amputees have several health risks: increased risk of musculoskeletal pain, osteoarthritis, cardiovascular

disease, falls and other injuries, which may diminish their quality of life.

The 294 participants of the cross-sectional cohort study of Wong et al[6] are amputees who are

attendees of the community-based wellness-walking program and they volunteered to participate in this

study and signed the written consent form. Among the participants, there were 40.8% unilateral transtibial

amputees and 33.7% transfemoral amputees while the remaining 2.9% has been amputated in both of their

upper and lower limbs. The researchers gathered information of the participants like demographic

information, medical history (weight-related medical comorbidities) and their answer to the question asked

to them if they try to lose weight through a questionnaire to be completed by the subjects. Houghston

Scale, Prosthetic Evaluation Questionnaire Mobility Subscale and 2-min Walk Test are used in the study.

However, the Houghston Scale and Prosthetic Evaluation Questionnaire Mobility Subscale are more

reliable and has higher validity to test compared to the execution of 2-min walk test. Timed Up and Go’s

reliability and validity has been determined with the lower limb amputees who use prosthesis. The A-BMI is

a web-based tool from the Amputation Coalition is freely accessible to be used to calculate for the adjusted-

BMI of the amputees. The Standard BMI and A-BMI values have substantial difference although they are

closely-related. Average BMI of 28.6% is lesser than the average A-BMI of 30.3% concluding that a subject

under the overweight category of the standard BMI would fall under the obesity I category of the A-BMI. In
the study, more of the subjects were men under the category of obese II in comparison with the women.

There were a lot of subjects under the overweight category in the standard BMI that has been reported

dieting while on the A-BMI, those that were categorized as overweight (normal in standard BMI) were not

dieting.

The cross-sectional study by Etjahed et al[13] was conducted on 235 Iranian male veterans with

bilateral lower limb amputation. The mean age of the amputees was 52 years, yet their mean age at the

time of amputation was 31.5 years. Demographics, anthropometrics (weight, waist and hip circumference,

and blood pressure), and biochemical measurements were assessed. MetS (metabolic syndrome) was

defined by National Cholesterol Education Program Adult Treatment Panel III definition, and Health-related

quality of life (HRQOL) was assessed using SF-36. There are so many factors that increase the risk of

MetS in the general population, such as genetic factors, sedentary lifestyle, unhealthy diets with high levels

of fat and sugar. Lower limb amputation affects ADLs and social performance, which affects weight and

increases the risk of cardiovascular disease and metabolic syndrome. The study found out that there was a

higher prevalence of veterans with MetS compared to the general population. They have twice the risk of

developing metabolic disorders (obesity, htn, hyperlipidemia, and hyperinsulinemia); yet, veterans with

bilateral above-knee amputations had significantly higher blood pressure, mean body fat content, weight

and insulin levels compared to age matched unilateral below-elbow amputees. Physical inactivity caused

by amputation could affect the quality of life in amputees, but there are limited studies concerning the

evaluation of HRQOL in amputees according to their metabolic disorders. Different factors including pain,

depression, social supports, prosthesis problems and social activity participation may have an effect on

HRQOL in amputees. Although having a major disability could greatly influence poor quality of life, the

study didn’t prove the association between MetS and HRQOL; thus, their correlation is still under

investigation.
Causes for lower limb amputation

In a retrospective study by Rouhani & Mohajerzadeh [14], 146 participants had lower limb

amputations. 80% of the amputated patients were male and 20 % were female. Trauma was observed the

most cause of amputation among lower limb amputations found in 67 cases, damage in tissues and

vascular complications found in 61 cases that requires to be amputated, and chronic infections found in 18

patients. Transtibial amputation were mostly performed in 115 cases (79%), Transfemoral amputation were

performed in 25 cases (17%) and Syme technique were done in 6 cases (4%). For male, trauma due to

accidents were found the most cause for amputation (50%), followed by vascular disorders (30%), and

infection (20%). For female, vascular disorder were found the most common cause for 80% of the cases

followed by trauma in 17% of cases and infections in only 3%.

The purpose of the study conducted by Larsson et al[15] was to compare the incidence of lower limb

amputation in the diabetic and non-diabetic general population, the study was conducted on population in

northern Scania , All lower limb amputations in this region are performed at one orthopedic department by

orthopedic surgeons, and patients considered for amputation related to vascular disease are assessed in

agreement with vascular surgeons The most common level for initial amputation in our study was the

transtibial level; the ratio of transtibial to higher-level amputation in diabetic patients This conservative

surgical approach in diabetic patients did not seem to increase the re amputation rate.

The study conducted by Pooja and Sangeeta[16] reported medical records of amputees in Kolkata,

West Bengal India, where in it included 155 amputees that underwent physiotherapy sessions and

prosthetic treatment and training, In South-East Asia, the prevalence of disability ranges from 1.5% to

21.3% of the total population, depending on the definition and severity of disability. Despite the increase in

prevalence of disability worldwide, not much attention has, for various reasons, been paid to its evaluation,

management, and prevention. Lower limb amputations were much more common than upper limb
amputations, the former accounting for 94.8% of all amputations, and the latter for only 5.2%. Among all

lower limb amputation cases, transtibial amputations were the most common, followed by transfemoral

amputation.

Berg Balance Scale Validity

One cross-sectional study by Major, Fatone, and Roth[17] used a total of 30 transtibial and

transfemoral amputees, whether unilateral or bilateral, as their participants have gone through the objective

of determining and evaluating how valid and reliable the Berg Balance Scale (BBS) as an outcome

measure in assessing an amputee’s balance capabilities. Aside from the BBS, the researchers also used

other outcome measures such as L-test, 2 Minute-walk test, and other stability or balance scale. The

researchers also used a self-report descriptor that were asked to the participants, incorporating the number

of falls the participant had experienced 12 months prior to the visit and how frequent the participant uses

his prosthesis, with or without any gait aid. Criteria of inclusion were the following: 1) Those who have an

amputation atleast above ankle, (2) amputees who experienced using prosthesis with or without gait aids

for assistance, (3) amputees of lower limb only, and (4) participants who has a healthy stump by means of

its skin condition. The participant went through the tests comfortably with their prosthesis. The researchers

then used 2 test to achieve their aim which are the interrater reliability and group discrimination, wherein 2

groups were labelled as fallers and non-fallers. As for the results, BBS had high interrater reliability with

intraclass correlation coefficient - .945 and high internal consistency of .827. The performance tests work

better than the questionnaires that have been used since it basically assesses the performance instead of

just the impression of capacity or activity level. For the group differences, the significant distinction was
seen only on the factor of fear of falling and with the use of gait aid during the execution. To sum it up, BBS

is highly reliable and valid than other assessing tool for balance in lower limb amputation.

According to the study by Downs, Marquez, and Chiarelli[18], poor balance increases risk of

injurious falls especially in elderly with subsequent disability. It is a challenge for health care to develop and

implement efficient and economical strategies preventing falls in older people. The Berg Balance Scale was

initially developed for measuring balance in the elderly and has since been used to variety of patients.

Lower scores of the Berg Balance Scale are correlated with high risk of injurious falls among community-

dwelling veterans. Among sedentary people, it shows that there’s an improvement of berg balance scores

and reported fewer falls for those who exercised. This study concluded that 70 year-old community dwelling

person that has no health conditions likely to undoubtedly affect their Berg balance scale, affecting their

balance. With supporting large sample of data, in estimation, there is a decline in Berg Balance Scale score

in persons aged 70 years old. It is indicated that BBS scores become more variable in community-dwelling

people with increasing age. On the basis of a clinician’s experience working with balance impaired people,

clinicians may easily underrate normal balance values of a healthy elderly and fail to set suitable treatment

goals for their patients to promote optimal balance.

In the study of Wong et al[19] 40 adult volunteers with leg amputations of any level that are

community dwellers were recruited from hospital based community support group and prosthetic clinics. Of

the 40 participants 26 were men and 14 were women with leg amputations (24 transtibial and 13

transfemoral and 3 bilateral). Adults who used assistive devices to walk were included, although balance

testing was performed without the use of the assistive devices. Informed consent were given, each

participant provided demographic data and medical, amputation, and prosthetic history. The participants

were asked to perform all 14 BBS items: sit to stand, standing unsupported, sitting unsupported, stand to

sit, transferring to chair, standing with eyes closed, standing with feet together, reaching forward with arm
outstretched, retrieving object from floor, looking behind over shoulders, turning 360 degrees, placing

alternate foot on stool, standing with 1 foot in front, and standing on 1 leg.Rating scale analysis was applied

to BBS scores obtained from a single assessment. Rasch RSA confirmed the unidimensionality of the BBS

for the assessment of balance and the internal validity of the scale, as reflected by the person and item

separation values and the high associated reliabilities. According to the author the present study

represents only the first step in the validation of the BBS for use with people after a leg amputation.

Additional research with larger samples of people with a leg amputation is warranted so that subsets of

participants can be examined separately. In conclusion the BBS cohered with the unidimensional construct

of balance ability and had strong internal validity for use in a variety of people with leg amputations.

According to the study of C.K. Wong[20], there is an excellent interrater (ICC [2,k]=.99) and

intrarater reliability (ICC [2,k]=.99) of BBS scores to people using prostheses that was tested by 16 people

with different levels of clinical experience. The 16 testers in this study were professionals and DPT students

that had or had no clinical training which scored the BBS assessment and showed an excellent interrater

reliability. The psychometric properties of the BBS have been reported to be excellent also for older

community-dwelling adults and neurologic-conditioned people.

Research Questions:

How can above and below normal BMI affect the falls risks among transtibial and transfemoral

amputees in UERMMMCI PSPO-CTC?


Research Objectives:

It is therefore the aim of this study to:

(1) Determine the prevalence of above & below normal BMI among LLA in UERMMMCI PSPO-

CTC Clinic

(2) Determine the correlation of above & below normal BMI among LLA with their falls risks

Significance of the Study:

The result of this study will benefit the LLA population through determining a possible cause that

contributes to their risks for falls and educate them about it to reduce their risks. Since only few studies

have been made about LLA in the Philippines, this can be used as a reference for PT & PO professionals

and even students and assist them in giving interventions that would directly address this factor.

Hypothesis:

Alternative Hypothesis: The researchers postulate that above normal & below normal BMI has a

correlation on LLA’s stability.

Null Hypothesis: The researchers postulate that above normal & below normal BMI has no

correlation on LLA’s stability

Scope and Limitations

This research will be a cross-sectional study; therefore, it will only determine the possible

relationship of falls risks and abnormal BMI among LLA, and not the exact cause of their falls risks. The
research also will not explore the effects of risks of falls to amputees and it will only determine the BMI of

the amputees as a factor of their risks falls, and so several other factors will not be explored. The research

excludes LLAs whom underwent treatment from facilities other than in the UERM CTC-PO clinic. The

research is limited to only unilateral transtibial and transfemoral amputation excluding any other levels of

amputations and bilateral amputees for these individuals may be wheelchair-bound. Only focused between

the ages of 18 – 60 years old; excluding pediatric amputees for their growth is not yet fully developed,

making their BMI harder to determine, and geriatric amputees for they have several factors that affects their

risk for falls. There are very limited studies regarding falls risks in amputees in general, thus, further

research must be conducted in order to strengthen its reliability.

Operational Definition of Terms

In order to have a better understanding of the study, terms are conceptually and operationally

defined.

 Adjusted-BMI/A-BMI – a screening tool used for the computation of the BMI LLA.

 Amputees – a patient who underwent amputation who is actively attending physical therapy

sessions in either UERM-CTC and UERM-PO Clinic

 BMI – the independent variable of interest

 Falls Risk – the dependent variable of interest

 Transfemoral – a patient who underwent above knee amputation who is actively attending physical

therapy sessions in UERM-CTC and UERM-PO clinics

 Transtibial - a patient who underwent below knee amputation who is actively attending physical

therapy sessions in UERM-CTC and UERM-PO clinics


 UERMMMCI – these are the UERM-CTC and UERM-PO clinic where the amputee participants are

taken from

 LLA - transtibial and transfemoral lower limb amputees that are participants of this study

Chapter 2

METHODOLOGY

This chapter presents the research setting, research design used, sampling, instrumentation, data

gathering procedure, statistical analysis, and ethical consideration.

Research Setting

The setting will be conducted on the UERMMMC-Clinic and Training Center (CTC) and

UERMMMC-PSPO Teaching Clinic (Philippine School of Prosthetics and Orthotics) of the Tan Yan Kee

building (TYK) of UERMMMCI along Kapiligan St., Quezon City. The setting is suitable for the study’s
location due to its familiarity, availability, and accessibility to the target subjects. This will also ensure and

guarantee secured and safe environment because of the presence of clinicians and healthcare

professionals in the clinic. The researchers will conduct the study within these places to measure LLA’s A-

BMI and assess their risk for falls via the Berg Balance Scale.

Research Design

This study will use a cross-sectional and correlational research design to determine the prevalence

of falls of these amputees with the use of the Adjusted-BMI (A-BMI) and analyze the relationship of the

Normal and Abnormal Body Mass Index of LLA in UERMMMCI-Clinic and Training Center & PSPO

Teaching Clinic with the falls risks of the LLA.

Cross-sectional research design will be utilized to analyze the data of variables: normal and

abnormal BMI to their falls risks, which are collected at a given point of time across a sample population.

Correlational research design determines whether an increase or decrease in BMI correlates to an increase

or decrease in the possibility of falls risks.

Sampling

The study will utilize a purposive sampling method to cater as many as participants as possible and

get maximum variation within the computed sample size. The sample size was computed utilizing the

formula for hypothesis testing using Wong et al’s study as a reference [12] (see Fig.1)

(𝑍𝑎 + 𝑍𝑏)2 + (𝑆12 + 𝑆22 )


𝑛=
(𝜇1 − 𝜇2)
(1.96 + 0.84)2 + (6.82 + 5.92 )
𝑛= = 58 participants
(29.9 − 25.2)

Fig. 1: Sample Size Computation

In the study, the subjects that will be recruited have the following characteristics:

1. Unilateral transfemoral and transtibial amputees from UERM-CTC and PSPO Clinic

2. Ages 18 – 60 years old

The following criteria are excluded in the study:

1. Geriatric Amputees

2. Pediatric Amputees

3. Bilateral amputations

4. Other level of amputations that excludes transfemoral and transtibial

5. Other comorbidities that may affect one’s balance (e.g. Low blood pressure, Positional

vertigo, eye muscle imbalance, etc.)[21]

Instrumentation

The researchers will utilize one interview tool: Participant Information Sheet (see Appendix A), and

two measuring tools: A-BMI and Berg Balance Scale, wherein the results will both be qualitative ordinal

data (see Appendix B and C). The participation information sheet will be used to gather the demographic

information of the subjects. The researchers will provide their own participation information sheet, which will
include: age, sex, address, civil status, and comorbidities. This will help in data collection regarding

demographic characteristics.

The A-BMI will be used to determine the corresponding adjusted body mass index of the unilateral

lower limb amputees. It provides a more accurate estimation of the amputee’s weight and its weight-related

health risks[6]. The A-BMI is a Web-based calculator that is freely accessible in the Amputee Coalition

website. It has the same categories with the standard BMI: underweight (below 18.5), normal (18.5 to 24.9),

overweight (25.0 to 29.9), and obese (30.0 and above). However, the range of values for each category is

different (See Appendix ). The A-BMI ranges are slightly higher as compared to the standard BMI ranges,

wherein a person under the overweight category in the standard BMI would be classified under the obese

category of the A-BMI[6].

The Berg Balance Scale (BBS) will be utilized to assess the falls risk of the unilateral lower limb

amputees. It has an excellent interrater (ICC [2,k]=.99) and intrarater (ICC [2,k]=.99) among testers who

assessed the balance of LLA with the use of Berg Balance Scale [20]. BBS is a 14-item objective measure,

with a five-point ordinal scale ranging from 0 to 4 for each item, implying that 0 has the lowest function and

4 as the highest, designed to assess the static and dynamic balance of the adult population [12]. The 14

tasks to be performed under this BBS are sit-to-stand, standing unsupported, sitting unsupported, standing

to sitting, transferring to chair, standing with eyes closed, standing with feet together, reaching forward with

arm out-stretched, retrieving objects from floor, looking behind over shoulders, turning 360 degrees, placing

alternate foot on stool, standing with one foot in front, and standing on one foot[19]. Total score that can be

achieved is 56, as there were 14 tasks that can be scored from 0 to 4. The Berg Balance Scale total scores

can be classified intro three interpretations that could help determine whether the subject is prone to falls or

not. Classified as high risks of fall or those who are considered as wheelchair bound is between the score
of 0 to 20, medium falls risks or the ones who can walk but with assistance is between 21 to 40, and 41-56

for those who are independent and has low risks of fall.

Data Gathering Procedure

In order to collect the subjects, the researchers will first attain permission from the Head of

CTC/PSPO clinic to have access to subjects’ demographic information, level of amputation, time since

amputation, contact number, and the permission to use CTC/PSPO laboratory facilities (See Appendix ).

The researchers will contact the subjects through phone call. Subjects who will respond and willing to

participate will be included. Subjects who will refuse to participate and will not respond will be encouraged

for reconsideration to participate. Subjects who will still refuse for reconsideration and who will still not

respond will be excluded from the study. Subjects who will respond upon contact for reconsideration and

will be willing to participate will be included.

The subjects that will be included in the study will be given an informed consent. Subject’s approval

upon informed consent will be interviewed during the scheduled time. The subjects who will decline will be

withdrawn from the study. During the interview, the subjects will be asked regarding their age, address, civil

status, and past medical history. After the interview, the subjects’ will be screened by measuring their

height and weight for BMI computation. The researchers then will calculate for the subjects’ estimated body

weight without their prosthesis by using the standard estimated percentage of total body mass for below-

knee and above-knee amputation. The researchers will calculate the subjects’ estimated BMI by using the

measured height and estimated body weight. The researchers then will classify the subjects according to

their estimated BMI.


Finally, Berg Balance Scale will be administered by the researchers to test subjects’ balance and

possible risk for falls. The subjects will be asked to perform various activities as indicated in the Berg

Balance Scale. Safety will be ensured through placing guard belt and close guarding will be done by the

researchers. The researchers will gather and total individual scores of each subject. The researchers then

will categorize the subjects according to the interpretation their totaled scores.

Permission from the Dean of The College of Allied


Rehabilitation Sciences

Participant Gathering via


Phone Calls

Providing Informed Consent

Demographic Interview

Measuring and Calculating


the A-BMI of Participants

Participant performs
activities as indicated by
the Berg Balance Scale
Tallying of Data

Analysis of Data
Fig. 2: Data Gathering Flowchart

Statistical Analysis

Descriptive statistic will summarize demographic, level of amputation, time since amputation, and

comorbidities. The A-BMI will be calculated by the researchers through the standard formula found on their

official website[22].

The participants will be classified according to the three-category of falls risks of the Berg Balance

Scale (low fall risk: 41 – 56; medium fall risk: 21 – 40; high fall risk: 0 – 20). The data that will be gathered

in the A-BMI and Berg Balance Scale will both be qualitative ordinal data. The magnitude of correlation of

the participants’ BMI and falls risks will be determined through the Spearman ρ correlation coefficients. The

categorical variables will be compared using the Chi-square test. The researchers will be using the SPSS

(Statistical Package for the Social Sciences) as a tool in calculating the data gathered.

Ethical Consideration

This research proposal will be submitted to the UERMMMMCI Research Institute of Health

Sciences for ethics review and approval. After approval has been sought from all the participants, the
research respondents will be given an informed consent with approval of the Head of CTC/PSPO clinic

enclosing assurance in safety, confidentiality, and anonymity of the participants. All participants will be

briefed regarding objectives, significance, and the methods of this study.

The researchers will ensure the safety of the participants through the following:

(1) Vital signs of the participant will be taken before and after the performance of tasks in the

Berg Balance Scale

(2) Guard belts will be used during the performance of tasks in the Berg Balance Scale

The researchers will ensure confidentiality of the participant’s data through the following:

(3) The participant’s name will be coded

(4) Only the researchers and the participants will have access to the data

(5) The participant’s data will be kept in only one password locked computer

(6) 5 years after the study, all data will be destroyed.


Chapter 3

DUMMY RESULTS

Table 1
Study Participant Characteristics by Berg Balance Scale Score (n=58)
High Risk for Falls Moderate Risk for Falls Low Risk for Falls
BBS Scoring: (0 –20) (21-40) (41-56)
Age
Mean age
Sex
Male
Female
Level of Amputation
Transtibial
Transfemoral
Time since amputation (yr.)
mean time
Comorbidity
None
DM
Htn
Others
Correlation between Falls Risks and BMI
1.2

0.8
Falls Risks

0.6
Y-Values
0.4

0.2

0
0 18.5
A-BMI

BUDGET

Budget Proposal

Expenses for the Participants Number of Participants Total

Transportation fee 200 60 12,000


Food 50 60 3,000

= Php 15,000
APPENDICES

Appendix A: Participant Information

INTERVIEW QUESTIONNAIRE

GENERAL INFORMATION
Name _____________________ Age ____ Sex ______
Address (optional) ___________________
Occupation ______________________
Handedness _______________________
Civil status ______________________
PATIENT INFORMATION
1. Level of Amputation
o Transtibial
o Transfemoral
2. Duration of Amputation
o 0 - 3 years
o 4 – 13 years
o >14 years
3. Comorbidities
o Hypertension
o Trauma
o Cardiovascular disease
o Peripheral Vascular Disease
o DM type: ____
o Others: _________________

Appendix B: A-BMI Web-based Calculator


Appendix C: Berg-Balance Scale

Description:
14-item scale designed to measure balance of the older adult in a clinical setting.
Equipment needed: Yardstick, 2 standard chairs (one with arm rests, one without), Footstool or step,
Stopwatch or wristwatch, 15 ft walkway
Scoring: A five-point ordinal scale, ranging from 0-4. “0” indicates the lowest level of function and “4” the
highest level of function. Score the LOWEST performance. Total Score = 56

Interpretation: 41-56 = independent


21-40 = walking with assistance
0 –20 = wheelchair bound
Berg K, Wood-Dauphinee S, Williams JI, Maki, B (1992). Measuring
balance in the elderly: validation of an instrument. Can. J. Pub. Health
July/August supplement 2:S7-11
Cut Off Scores:
 Score of < 45 indicates individuals may be at greater risk of falling (Berg, 1992)
Berg K, Wood-Dauphinee S, Williams JI, Maki, B. (1992). Measuring
balance in the elderly: validation of an instrument. Can. J. Pub. Health
July/August supplement 2:S7-11
 History of falls and BBS < 51, or no history of falls and BBS < 42 is predictive of falls
(91% sensitivity, 82% specificity) (Shumway-Cook, 1997)
 Score of < 40 on BBS associated with almost 100% fall risk (Shumway-Cook, 1997)
(n = 44, mean age = 74.6 (5.4) years for non-fallers, 77.6 (7.8) for fallers)
Shumway-Cook, A., Baldwin, M., et al. (1997). Predicting the probability
for falls in community-dwelling older adults. Physical Therapy 77(8): 812-
819
Retrieved 10-5-2014 from Rehab Measures Database.
http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=
888

Comments: Potential ceiling effect with higher level patients. Scale does not include gait items

Minimal Detectable Change:


“A change of 4 points is needed to be 95% confident that true change has occurred if a patient scores
within 45-56 initially, 5 points if they score within 35-44, 7 points if they score within 25-34 and, finally, 5
points if their initial score is within 0-24 on the Berg Balance Scale.”
Donoghue D; Physiotherapy Research and Older People (PROP) group, Stokes
EK. (2009). How much change is true change? The minimum detectable change
of the Berg Balance Scale in elderly people. J Rehabil Med. 41(5):343-6.
Norms:
Lusardi, M.M. (2004). Functional Performance in Community Living Older
Adults. Journal of Geriatric Physical Therapy, 26(3), 14-22.

Berg Balance Scale

Name: __________________________________ Date: ___________________

Location: ________________________________ Rater: ___________________

ITEM DESCRIPTION SCORE (0-4)

1. Sitting to standing ________


2. Standing unsupported ________
3. Sitting unsupported ________
4. Standing to sitting ________
5. Transfers ________
6. Standing with eyes closed ________
7. Standing with feet together ________
8. Reaching forward with outstretched arm ________
9. Retrieving object from floor ________
10. Turning to look behind ________
11. Turning 360 degrees ________
12. Placing alternate foot on stool ________
13. Standing with one foot in front ________
14. Standing on one foot ________

Total ________

GENERAL INSTRUCTIONS
Please document each task and/or give instructions as written. When scoring, please record the lowest
response category that applies for each item.

In most items, the subject is asked to maintain a given position for a specific time. Progressively more
points are deducted if:
 the time or distance requirements are not met
 the subject’s performance warrants supervision
 the subject touches an external support or receives assistance from the examiner
Subject should understand that they must maintain their balance while attempting the tasks. The choices of
which leg to stand on or how far to reach are left to the subject. Poor judgment will adversely influence the
performance and the scoring.

Equipment required for testing is a stopwatch or watch with a second hand, and a ruler or other indicator of
2, 5, and 10 inches. Chairs used during testing should be a reasonable height. Either a step or a stool of
average step height may be used for item # 12.

Berg Balance Scale


1. SITTING TO STANDING
INSTRUCTIONS: Please stand up. Try not to use your hand for support.
( ) 4 able to stand without using hands and stabilize independently
( ) 3 able to stand independently using hands
( ) 2 able to stand using hands after several tries
( ) 1 needs minimal aid to stand or stabilize
( ) 0 needs moderate or maximal assist to stand

2. STANDING UNSUPPORTED
INSTRUCTIONS: Please stand for two minutes without holding on.
( ) 4 able to stand safely for 2 minutes
( ) 3 able to stand 2 minutes with supervision
( ) 2 able to stand 30 seconds unsupported
( ) 1 needs several tries to stand 30 seconds unsupported
( ) 0 unable to stand 30 seconds unsupported

If a subject is able to stand 2 minutes unsupported, score full points for sitting unsupported. Proceed to item
#4.

3. SITTING WITH BACK UNSUPPORTED BUT FEET SUPPORTED ON FLOOR OR ON A STOOL


INSTRUCTIONS: Please sit with arms folded for 2 minutes.
( ) 4 able to sit safely and securely for 2 minutes
( ) 3 able to sit 2 minutes under supervision
( ) 2 able to able to sit 30 seconds
( ) 1 able to sit 10 seconds
( ) 0 unable to sit without support 10 seconds

4. STANDING TO SITTING
INSTRUCTIONS: Please sit down.
( ) 4 sits safely with minimal use of hands
( ) 3 controls descent by using hands
( ) 2 uses back of legs against chair to control descent
( ) 1 sits independently but has uncontrolled descent
( ) 0 needs assist to sit

5. TRANSFERS
INSTRUCTIONS: Arrange chair(s) for pivot transfer. Ask subject to transfer one way toward a seat with
armrests and one way toward a seat without armrests. You may use two chairs (one with and one without
armrests) or a bed and a chair.
( ) 4 able to transfer safely with minor use of hands
( ) 3 able to transfer safely definite need of hands
( ) 2 able to transfer with verbal cuing and/or supervision
( ) 1 needs one person to assist
( ) 0 needs two people to assist or supervise to be safe

6. STANDING UNSUPPORTED WITH EYES CLOSED


INSTRUCTIONS: Please close your eyes and stand still for 10 seconds.
( ) 4 able to stand 10 seconds safely
( ) 3 able to stand 10 seconds with supervision
( ) 2 able to stand 3 seconds
( ) 1 unable to keep eyes closed 3 seconds but stays safely
( ) 0 needs help to keep from falling

7. STANDING UNSUPPORTED WITH FEET TOGETHER


INSTRUCTIONS: Place your feet together and stand without holding on.
( ) 4 able to place feet together independently and stand 1 minute safely
( ) 3 able to place feet together independently and stand 1 minute with supervision
( ) 2 able to place feet together independently but unable to hold for 30 seconds
( ) 1 needs help to attain position but able to stand 15 seconds feet together
( ) 0 needs help to attain position and unable to hold for 15 seconds

8. REACHING FORWARD WITH OUTSTRETCHED ARM WHILE STANDING


INSTRUCTIONS: Lift arm to 90 degrees. Stretch out your fingers and reach forward as far as you can.
(Examiner places a ruler at the end of fingertips when arm is at 90 degrees. Fingers should not touch the
ruler while reaching forward. The recorded measure is the distance forward that the fingers reach while the
subject is in the most forward lean position. When possible, ask subject to use both arms when reaching to
avoid rotation of the trunk.)
( ) 4 can reach forward confidently 25 cm (10 inches)
( ) 3 can reach forward 12 cm (5 inches)
( ) 2 can reach forward 5 cm (2 inches)
( ) 1 reaches forward but needs supervision
( ) 0 loses balance while trying/requires external support

9. PICK UP OBJECT FROM THE FLOOR FROM A STANDING POSITION


INSTRUCTIONS: Pick up the shoe/slipper, which is place in front of your feet.
( ) 4 able to pick up slipper safely and easily
( ) 3 able to pick up slipper but needs supervision
( ) 2 unable to pick up but reaches 2-5 cm(1-2 inches) from slipper and keeps balance independently
( ) 1 unable to pick up and needs supervision while trying
( ) 0 unable to try/needs assist to keep from losing balance or falling

10. TURNING TO LOOK BEHIND OVER LEFT AND RIGHT SHOULDERS WHILE STANDING
INSTRUCTIONS: Turn to look directly behind you over toward the left shoulder. Repeat to the right.
Examiner may pick an object to look at directly behind the subject to encourage a better twist turn.
( ) 4 looks behind from both sides and weight shifts well
( ) 3 looks behind one side only other side shows less weight shift
( ) 2 turns sideways only but maintains balance
( ) 1 needs supervision when turning
( ) 0 needs assist to keep from losing balance or falling

11. TURN 360 DEGREES


INSTRUCTIONS: Turn completely around in a full circle. Pause. Then turn a full circle in the other direction.
( ) 4 able to turn 360 degrees safely in 4 seconds or less
( ) 3 able to turn 360 degrees safely one side only 4 seconds or less
( ) 2 able to turn 360 degrees safely but slowly
( ) 1 needs close supervision or verbal cuing
( ) 0 needs assistance while turning

12. PLACE ALTERNATE FOOT ON STEP OR STOOL WHILE STANDING UNSUPPORTED


INSTRUCTIONS: Place each foot alternately on the step/stool. Continue until each foot has touch the
step/stool four times.
( ) 4 able to stand independently and safely and complete 8 steps in 20 seconds
( ) 3 able to stand independently and complete 8 steps in > 20 seconds
( ) 2 able to complete 4 steps without aid with supervision
( ) 1 able to complete > 2 steps needs minimal assist
( ) 0 needs assistance to keep from falling/unable to try

13. STANDING UNSUPPORTED ONE FOOT IN FRONT


INSTRUCTIONS: (DEMONSTRATE TO SUBJECT) Place one foot directly in front of the other. If you feel
that you cannot place your foot directly in front, try to step far enough ahead that the heel of your forward
foot is ahead of the toes of the other foot. (To score 3 points, the length of the step should exceed the
length of the other foot and the width of the stance should approximate the subject’s normal stride width.)
( ) 4 able to place foot tandem independently and hold 30 seconds
( ) 3 able to place foot ahead independently and hold 30 seconds
( ) 2 able to take small step independently and hold 30 seconds
( ) 1 needs help to step but can hold 15 seconds
( ) 0 loses balance while stepping or standing

14. STANDING ON ONE LEG


INSTRUCTIONS: Stand on one leg as long as you can without holding on.
( ) 4 able to lift leg independently and hold > 10 seconds
( ) 3 able to lift leg independently and hold 5-10 seconds
( ) 2 able to lift leg independently and hold ≥ 3 seconds
( ) 1 tries to lift leg unable to hold 3 seconds but remains standing
independently.
( ) 0 unable to try of needs assist to prevent fall

( ) TOTAL SCORE (Maximum = 56)

Appendix D: Request Letter

University of the East


RAMON MAGSAYSAY MEMORIAL MEDICAL CENTER, INC.
College of Allied Rehabilitation Services

July 25, 2018


Nikolai R. Santos PTRP, CPO
Clinic Manager – PSPO Charity Clinic
College of Allied Rehabilitation Sciences
University of the East Ramon Magsaysay Memorial Medical Center

Dear Mr. Santos,


On behalf of our research group, please accept this letter as a formal request for us to have an access on
patients’ records regarding amputees to get the following information:
1. Total number of lower limb amputees and the specified number of transtibial and transfemoral
amputees since year 2013 for the researchers to determine the sample size which requires the
total number of subjects.
2. Date of the amputees most recent or last visit in the CTC-PSPO clinic to know the chance of
recruiting them
3. Amputees’ demographic information for data screening.
4. Level and time since amputation and acquisition date of prosthesis of the amputee for the
researchers’ reference for data analysis.
5. Transtibial and transfemoral amputees’ contact information for us to invite them in the PSPO-CTC
clinic for data gathering
I greatly appreciate your consideration and assistance with this request, as this would be a great
importance in determining the sample size which will require the total number of our subjects that will be
included in our group’s research entitled “A Cross-sectional study of Above and Below Normal BMI among
Lower Limb Amputees in UERMMMCI PSPO-CTC to the their fall risks”. We guarantee that the data that
we are requesting will remain confidential among the research group members.

Respectfully,
Channelle Ellima
Primary Investigator
Noted by
Japhet Gerard Regidor, CPO Christian Gabriel Lee, PTRP
Research Adviser Research Adviser
Appendix E: Informed Consent (Tagalog)

IMPORMASYON SA PASYENTE AT KASULATAN NG MAY KAALAMANG PAHINTULOT


Ikaw ay inaanyayahan na kusang loob na lumahok sa pananaliksik na pinamagatang “A Cross-sectional
Study of Above & Below Normal BMI Among Lower Limb Amputees in UERMMMCI PSPO-CTC to their
Falls Risks” sa pamamahala ni Channelle M. Ellima (Primary Investigator).
Bago po kayo pumayag na sumali sa pag-aaral na ito, kailangan po ninyong malaman ang mga panganib
at mga benepisyo para kayo ay makagawa ng isang may kaalamang desisyon. Ang prosesong ito ay kilala
bilang “may kaalamang pahintulot”.
Ang kasulatan ng pahintulot na ito ay magsasabi sa inyo tungkol sa pag-aaral na maaaring nais ninyong
salihan. Kung maaari po ay basahin ninyong mabuti ang impormasyon at pag-usapan ninyo ng sinuman na
gusto ninyo. Maaari pong kabilang dito ang isang kaibigan o isang kamag-anak. Kung mayroon po kayong
mga katanungan mangyaring hilingin sa Pangunahing Imbestigador o tauhan ng pag-aaral na sagutin ang
mga ito.
Ang layunin ng pananaliksik ay tuklasin ang kaugnayan ng normal at hindi normal na Body Mass Index
(BMI) sa panganib sa paghulog sa mga transtibial at transfemoral amputees sa UERMMMCI PSPO-CTC.
Ang Bilang ng kasali sa pagaaral na ito ay 58
Kayo po ay isa sa mga napiling kalahok sa pag-aaral na ito dahil kayo ay isang transtibial o transfemoral
amputee na nasa edad na 18-60 na nakatanggap at gumagamit na ng prosthesis.
Ang iyong paglahok sa pagaaral na ito ay tatagal ng 35 minuto.
Sa pag-aaral na ito kayo po ay iinterbyuhin sa pamamagitan ng personal na pakikinayam tungkol sa mga
sagot ninyo sa isang questionnaire na ginawa ng mga mananaliksik, kukunin ang inyong BMI at
pagkatapos ay papagawin ng mga gawain na nakasaad sa Berg Balance Scale katulad ng pagbalanse
habang nakaupo, pag-abot ng gamit sa lapag mula sa pagtayo, pagtayo sa isang paa nang walang
suporta,. Ang talatanungan ay binubuo ng sampung katangungan tungkol sa pangkalahatang impormasyon
at tagal ng pag-gamit ng instrumentong panglakad. Samantala, ang iyong BMI ay makukuha sa
pamamagitan ng pagsukat ng inyong taas at bigat ng timbang. Sa pagsasagawa ng mga gawaing
nakasaad sa Berg Balance Scale, ikaw ay tutulungan at gagabayan ng mga mananaliksik.
Sa pag-aral na ito. kayo po ay inaasahan na sumagot sa mga katanungan ng tama at tapat at gawin ang
mga nakasaad na gawain sa Berg Balance Scale.
Ang Pangunahing Imbestigador ay may kakayahang tanggalin kayo mula sa pag-aaral na ito sa anumang
makatwirang dahilan ayon sa protokol. Mga halimbawa kung bakit kayo tatangalin ay hindi magandang
pag-uugali katulad na lamang ng pananakit o panghaharass ng kung sino man sa pag-aaral, o pagtaas ng
presyon na higit sa normal (systolic: > 20 mmhg & diastolic: > 10 mmhg).
Maari ninyo pong bawiin ang inyong pahintulot mula sa partisipasyon sa pag-aaral na ito sa kahit anong
yugto ng pagkuha ng impormasyon sa inyo. Mahalaga po na ipaalam ninyo ito sa inyong Pangunahing
Imbestigador. Ang Pangunahing Imbestigador na ang impomasyong nakuha sa inyo ay mapapanatiling
kompidensyal at tanging ang mga mananaliksik lang ang may kakayahang makakita nito. Wala nang
karagdagang mga gawain na may kaugnayan sa pag-aaral ang magaganap.Maaari ninyong pag-usapan
ng inyong Pangunahing Imbestigador ang karagdagan pang regular na medikal na pangangalaga. Ang
kagustuhang bumitiw mula sa partisipasyon sa pananaliksik ay hindi makaka-apekto sa inyong medikal na
pangangalaga. Maliban kung kinakailangan ng batas, ang inyong pangalan ay hindi ibubunyag sa labas ng
klinika ng pananaliksik. Ang inyong pangalan ay makukuha lamang ng sumusunod na mga tao o mga
ahensya: ng Pangunahing Imbestigador at ng tauhan at awtorisadong mga kinatawan ng Pangunahing
Imbestigador; ethics committees o ng mga inspektor ng awtoridad na pangkalusugan,Habang kasali sa
pag-aaral na ito, papalitan ng Pangunahing Imbestigador ang inyong pangalan ng isang espesyal na
pantukoy na kikilala sa inyo.
Walang inaasahang hindi kaaya-ayang pangyayari sa pag-aaral na ito; kung sakali na meron, mayroong
malapit na ospital sa pag-gaganapan ng pag-aaral.
Ang iyong pakinabang sa pagsali sa pagaaral na ito ay ang pagkakaroon ng kamalayan tungkol sa
maaaring maidulot ng iyong katawan sa panganib ng pagkahulog.
Walang magiging gastos sa inyo sa pakikilahok sa pag-aaral na ito. Kayo po ay tantangap ng kaukulang
kompensasyon para sa inyong pagkain at transportasyon sa tuwing babalik sa pagaaral.
Ang kabutihang dulot ng pag-aaral na ito sa komunidad ay makakapagbigay ito ng pansin sa koneksyon ng
BMI ng amputee sa kanilang posibleng pagkahulog. Magkakaroon ng ideya ang lipunan sa mga maaaring
maging epekto ng pagkakaroon ng abnormal na BMI sa kanilang posibleng pagkakatumba na magiging
dahilan para magkaroon sila ng kamalayan at tanggapin ang problema na dapat kailangan maalagaan ang
katawan. Ito ay magiging dahilan para mahikayat na din ang komunidad na magkaroon ng magandang
pamumuhay para sa malusog na pangangatawan.
Kung gawin nyo ito, ang inyong partisipasyon sa pag-aaral ay magtatapos at ang tauhan ng pag-aaral ay
titigil sa pagkolekta ng impormasyon mula sa inyo.
May karapatan kayong pagbalik-aralan ang inyong Impormasyon ng Pag-aaral at mga medikal na tala at
humiling ng mga pagbabago sa Impormasyon ng Pag-aaral kung ito ay hindi tama. Gayunpaman,
pakitandaan na sa panahon ng pag-aaral, ang pagtingin sa Impormasyon ng Pag-aaral ay maaaring
limitado kung ito ay nagpapahina sa integridad ng pananaliksik. Maaari ninyong matingnan ang
Impormasyon ng Pag-aaral na hawak ng Pangunahing Imbestigador sa katapusan ng pag-aaral.
Maaari kang magtanong ng kahit anong oras hinggil sa pag-aaral na ito. Ang tatawagan at kakausapin ay
si Channelle M. Ellima (09458397960) at Aidan Lloyd N. Crucis (09565541633).
Ang pag-aaral na ito ay inaprubahan ng Research Institute for Health Sciences Ethics Review Committee.
Kung mayroon kayong mga katanungan kaugnay sa inyong mga karapatan bilang isang kalahok sa
pananaliksik, paki-kontak:

Research Institute for Health Sciences ERC Panel Chair: Maria Milagros U. Magat, MD, MEM.
Address: 2/F JMC Bldg. Aurora Blvd. Quezon City
Email: research@uerm.edu.ph
Numero ng Telepono: +63 2 7161843
Numero ng Cellphone: 09258528048
Nabasa ko ang dokumentong ito naipaliwanag sa akin ang mga nilalaman nito. Naiintindihan ko ang
layunin nitong pag-aaral at kung ano ang mangyayari sa akin sa pag-aaral na ito. Malaya kong ibinibigay
ang aking pahintulot na sumali sa pag-aaral na ito, gaya ng inilarawan sa akin sa dokumentong ito.
Naiintindihan ko na tatanggap ako ng kopya ng dokumentong ito na pinirmahan sa ibaba.
Sa pag pirma sa kasulatan ng pahintulot na ito, pinahihintulutan ko ang paggamit, pagtingin, at
pagbabahagi ng aking personal na medical na impormasyon gaya ng inilarawan sa seksyong “Pagiging
Lihim at Pahintulot na makolekta, magamit at maibunyag ang Personal na Medikal na Impormasyon”. Ang
pahintulot na ito ay may bias maliban na lang at hanggang sa bawiin ko ito.

Pangalan ng Pasyente Pirma Petsa


(isatitik ang pangalan)

Pangalan ng Kinatawang legal Pirma Petsa


(legal na awtorisadong gumawa bilang personal na kinatawan sa
pag pirma para kay [pangalan ng pasyente) (isatitik ang
pangalan)

Pangalan ng Imbestigador Pirma Petsa


(isatitik ang pangalan)

Pangalan ng nagpahayag Pirma Petsa


(nagpahayag/nagpaliwanag ng dokumento)
(isatitik ang pangalan)

Ang dalawang kahon ay nakalaan para sa marka ng hinlalaki ng kamay. Ito ay para lamang sa mga
pasyenteng hindi nakakabasa at nakakasulat.
Appendix F: Informed Consent (English)
Patient Information and Informed Consent Form
You are being invited to participate voluntarily in the study entitled “A Cross-sectional Study of Above &
Below Normal BMI Among Lower Limb Amputees in UERMMMCI PSPO-CTC to their Falls Risks” under
the supervision of Channelle M. Ellima (Primary Investigator).
Before you agree to join in this study, you need to know the risks and benefits so you can make an
informed decision. This process is known as “informed consent”.
This consent form tells you about the study that you may wish to join. Please read the information carefully
and discuss it with anyone you want. This may include a friend or a relative. If you have questions please
ask the Principal Investigator or study staff to answer them.
The objective of the study is to determine the prevalence of above and below normal Body Mass Index
(BMI) among lower limb amputees in UERMMMCI PSPO-CTC and to identify the correlation of above &
below normal BMI lower limb amputees and their falls risks.
The number of study participants is 58
You are chosen to participate in this study because you are a unilateral transfemoral or transtibial amputee,
aged 18-60 who has already received and currently using his/her prosthesis.
The duration of your participation in the study will be approximately within 35 minutes.
In this study, you will be interviewed personally (i.e. active and discharged patients), about your answers to
an interview questionnaire composed by the researchers themselves and you will be assessed to get your
BMI and also, perform certain tasks from the Berg Balance Scale (e.g. sitting to standing, standing
unsupported, standing with eyes closed, standing on one foot, etc.) The interview questionnaire is
composed of 10 questions about your general information and duration of amputation. The BMI will be
assessed by getting your height and weight, while in the performance of tasks in the Berg Balance Scale;
you will be assisted and guided by the researchers.
Your responsibilities as a study subject include the answering of the questionnaire honestly and performing
the tasks indicated in the Berg Balance Scale properly.
The Principal Investigator may remove you from this study for any justified reason according to the
protocol. Examples of such reasons are display of inappropriate behavior like harassing people/researchers
in the study, or a sudden drastic change in your blood pressure (systolic: > 20 mmhg & diastolic: > 10
mmhg).
.
You may withdraw your consent from participation in this study at any time. It is important that you inform
the Principal Investigator in writing. The Principal Investigator will continue to retain and use any research
results that have already been collected for the study evaluation. No further study-related activities will take
place. The choice to withdraw from research participation will have no repercussions.
There is no expected risk in participating in this study. However, if there are any adverse effects, a nearby
hospital where the study is being conducted is accessible.
The benefits of participating in this study include you to become more aware of the risk of falling with
regards to your BMI. You will also gain knowledge about the relationship of the normal & abnormal BMI to
the falls risks among lower limb amputees in UERMMMCI PSPO-CTC. Snacks will be given as tokens of
appreciation.
There will be no monetary costs to you for participating in this study. You will be given a token of
appreciation for your participation to cover expenses such as transportation and meals.
This study will benefit the community by giving awareness regarding the relationship of BMI of amputees to
their falls risks. The community will have the idea on the possible effects of having abnormal BMI to their
risk for falls and so the community will be aware and recognize the problem that they should find ways on
how they will manage their body. It will then help encourage the society to get a better lifestyle to maintain a
good health to reduce the risks for falls
Unless required by law, your name will not be disclosed outside the research clinic. Your name will be
available only to the following people or agencies: the Principal Investigator and staff; and authorized
representatives of the Principal Investigator; ethics committees and health authority inspectors. While
participating in this study, the Principal Investigator will replace your name with a special code that
identifies you.
Your participation in this study is voluntary and you may cancel this consent at any time and without any
reason. If you do so, your participation in the study will end and the study staff will stop collecting
information from you.
You have the right to review your Study Information and request changes to the Study Information if it is not
correct. However, please note that during the study, access to Study Information may be limited if it
weakens the integrity of the research. You may have access to the Study Information held by the Principal
Investigator at the end of the study.
You can call or ask questions anytime regarding this study. The contact person for further information or
for consultation on diverse events is Channelle M. Ellima (09458397960) or Aidan Lloyd N. Crucis
(09565541633)
This study has been approved for implementation by the Research Institute for Health Sciences Ethics
Review Committee. If you have questions related to your rights as a research subject, please contact:
Research Institute for Health Sciences ERC Panel Chair: Maria Milagros U. Magat, MD, MEM.
Address: 2/F JMC Bldg. Aurora Blvd. Quezon City
Email: research@uerm.edu.ph
Telephone No.: +63 2 7161843
Cellphone No: 09258528048

I have read this document/had its contents explained to me. I understand the purpose of this study and
what will happen to me in this study. I do freely give my consent to join in this study, as described to me in
this document. I understand that I will receive a copy of this document as signed below.
By signing this consent form, I authorize the use, access, and sharing of my personal medical information
as described in the section “Confidentiality and Authorization to collect, use and disclose Personal Medical
Information”. This consent is valid unless and until I revoke it.
Patient Signature Date
type/print name

Legally acceptable representative Signature Date


(legally authorized to act as personal representative to sign for
[name of patient]) type/print name

Investigator Signature Date


type/print name

Name of presenter Signature Date


(who presented/explained the document)
type/print name

Two spaces are provided for thumb marks. ONLY if the participant is illiterate.

Appendix G: Timeline

Tasks July Aug Sep Oct


Week 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3
1. Draft 1 Manuscript Submission
2. ICH GCP Seminar
3. Powerpoint draft 1 dry run
4. Draft 2 Manuscript Submission
5. Powerpoint draft 2 dry run
6. Draft 3 Manuscript Submission
7. Final Proposal Defense / Proposal re-defense
8. RIHS paper processing recruitment
9. RIHS Approval
10. Recruitment of subjects
11. Screening of subjects
12. Implementation of intervention (if any)
13. Data collection period
14. Mandatory last day of data collection
CURRICULUM VITAE

ELLIMA, CHANNELLE, MATUTINO


Primary Investigator

Home Address: Blk 10 Lot 2 Crisologo St. cor. Bugallon Woodsite 3,


Bahayang Pagasa, Imus, Cavite
E-mail Address: ellimachannelle@gmail.com
Contact No.: 09458397960
Sex: Female

Personal Information

Date of Birth September 15, 1999


Place of Birth San Juan De Dios Educational Foundation, Inc. Hospital, Pasay City
Age 18
Nationality Filipino
Religion Roman Catholic
Civil Status Single
Father’s Name Reynaldo P. Ellima
Mother’s Name Edely Sophie M. Ellima

Educational Background

Tertiary University of the East Ramon Magsaysay Memorial Medical Center, Inc.
BS Physical Therapy
64 Aurora Blvd, Brgy Dona Imelda, Quezon City, Philippines
2016

San Juan De Dios Educational Foundation, Inc.


BS Physical Therapy
Roxas Blvd, Pasay City, Metro Manila, Philippines
2015 - 2016

Secondary Woodridge College


Espeleta, Bacoor Cavite, Philippines
2011 - 2015

Primary St. Thomas More Academy


Bahayang Pagasa, Molino, Cavite, Philippines
2008 – 2011

San Isidro Catholic School


Taft Ave, Pasay, Metro Manila, Philippines
2005 – 20088
Awards and Accomplishments

Undergraduate
Dean’s Lister 2015 - 2016
San Juan De Dios Educational Foundation, Inc.

High School
None

Elementary
None

Affiliated Organizations

Organization None Year


Position
Institution (if any)
Address

Seminars and Trainings

International Conference on
Harmonization on Good Clinical Practice Workshop August 10, 2018
UERMMMCI-College of Allied Rehabilitation Sciences
64 Aurora Boulevard, Barangay Dona Imelda, Quezon City, Philippines
MERIN, ALEXANDRENE DANIELLE ORIEL
Co-investigator

1231 – G. Castaños St. Sampaloc, Manila


xandrenemerin@gmail.com
09957201054
Female

Personal Information

Date of Birth March 14, 1997


Place of Birth Manila
Age 21 y/o
Nationality Filipino
Religion Catholic
Civil Status Single
Father’s Name Renato M. Merin.
Mother’s Name Blandina O. Merin

Educational Background

Tertiary UNIVERSITY OF THE EAST RAMON MAGSAYSAY MEMORIAL MEDICAL


CENTER, INC
Bachelor of Science in Physical Therapy
64 Aurora Boulevard, Barangay Doña Imelda, Quezon City
2014 -

Secondary LA CONSOLACION COLLEGE – MANILA


8 Mendiola St. San Miguel, Manila
2010 – 2014

Primary LA CONSOLACION COLLEGE - MANILA


8 Mendiola St. San Miguel, Manila
2008 – 2010

SAN SEBASTIAN COLLEGE RECOLETOS - MANILA


Recto Avenue, Quiapo, Manila
2004 - 2008

Awards and Accomplishments

Undergraduate
NONE

High School
First Honorable Mention 2013 - 2014
Mercury Drug – Best in Science
Leadership Award – Student Coordinating Body
Membership Award – Homemakers’ Club
Honor in Deportment
La Consolacion College - Manila

Elementary
Achievement Awardee 2009 - 2010
La Consolacion College - Manila

Affiliated Organizations

Organization NONE Year


Position
Institution (if any)
Address

Seminars and Trainings

International Conference on
Harmonization on Good Clinical Practice Workshop August 10, 2018
UERMMMCI-College of Allied Rehabilitation Sciences
64 Aurora Boulevard, Barangay Dona Imelda, Quezon City, Philippines

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2. Stommel M, Schoenborn CA. Accuracy and usefulness of BMI measures based on self-reported

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and mortality in elderly men and women: the Tromsø and HUNT studies. J epidemiol community

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rehabilitation medicine. 2015 Jan 5;47(1):80-6.

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Soveid M. Prevalence of metabolic syndrome and health-related quality of life in war-related

bilateral lower limb amputees. Journal of Diabetes & Metabolic Disorders. 2017 Dec;16(1):17.

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bmi/)]

[1]
Freedman DS, Horlick M, Berenson GS. A comparison of the Slaughter skinfold-thickness equations and BMI in predicting
body fatness and cardiovascular disease risk factor levels in children–. The American journal of clinical nutrition. 2013 Oct
23;98(6):1417-24.
[2] Stommel M, Schoenborn CA. Accuracy and usefulness of BMI measures based on self-reported weight and height: findings

from the NHANES & NHIS 2001-2006. BMC public health. 2009 Dec;9(1):421.
[3] Kvamme, J., Holmen, J., Wilsgaard, T., Florholmen, J., Midthjell, K., & Jacobsen, B. K. (2011). Body mass index and mortality

in elderly men and women: the Tromsø and HUNT studies. Journal of Epidemiology and Community Health, 66(7), 611-617.
doi:10.1136/jech.2010.123232
[4] Jahangir E, De Schutter A, Lavie CJ. Low weight and overweightness in older adults: risk and clinical management. Progress

in cardiovascular diseases. 2014 Sep 1;57(2):127-33.


[5] Littman AJ, Thompson ML, Arterburn DE, Bouldin E, Haselkorn JK, Sangeorzan BJ, Boyko EJ. Lower-limb amputation and

body weight changes in men. Journal of Rehabilitation Research & Development. 2015 Feb 1;52(2).
[5] Littman AJ, Thompson ML, Arterburn DE, Bouldin E, Haselkorn JK, Sangeorzan BJ, Boyko EJ. Lower-limb amputation and
body weight changes in men. Journal of Rehabilitation Research & Development. 2015 Feb 1;52(2).
[6] Wong CK, Wong RJ. Standard and Amputation-Adjusted Body Mass Index Measures: Comparison and Relevance to

Functional Measures, Weight-Related Comorbidities, and Dieting. American journal of physical medicine & rehabilitation. 2017
Dec 1;96(12):912-5.
[6] Wong CK, Wong RJ. Standard and Amputation-Adjusted Body Mass Index Measures: Comparison and Relevance to

Functional Measures, Weight-Related Comorbidities, and Dieting. American journal of physical medicine & rehabilitation. 2017
Dec 1;96(12):912-5.
[7] Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk factors for falls in people with a lower limb amputation:

a systematic review. PM&R. 2017 Feb 1;9(2):170-80.


[7] Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk factors for falls in people with a lower limb amputation:

a systematic review. PM&R. 2017 Feb 1;9(2):170-80.


[7] Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk factors for falls in people with a lower limb amputation:

a systematic review. PM&R. 2017 Feb 1;9(2):170-80.


[6] Wong CK, Wong RJ. Standard and Amputation-Adjusted Body Mass Index Measures: Comparison and Relevance to

Functional Measures, Weight-Related Comorbidities, and Dieting. American journal of physical medicine & rehabilitation. 2017
Dec 1;96(12):912-5.
[8] Steinberg N, Gottlieb A, Siev-Ner I, Plotnik M. Fall incidence and associated risk factors among people with a lower limb

amputation during various stages of recovery–a systematic review. Disability and rehabilitation. 2018 Mar 14:1-0.
[4] Jahangir E, De Schutter A, Lavie CJ. Low weight and overweightness in older adults: risk and clinical management. Progress

in cardiovascular diseases. 2014 Sep 1;57(2):127-33.


[2] Stommel M, Schoenborn CA. Accuracy and usefulness of BMI measures based on self-reported weight and height: findings

from the NHANES & NHIS 2001-2006. BMC public health. 2009 Dec;9(1):421.
[3] Kvamme JM, Holmen J, Wilsgaard T, Florholmen J, Midthjell K, Jacobsen BK. Body mass index and mortality in elderly men

and women: the Tromsø and HUNT studies. J epidemiol community health. 2012 Jul 1;66(7):611-7.
[1] Freedman DS, Horlick M, Berenson GS. A comparison of the Slaughter skinfold-thickness equations and BMI in predicting

body fatness and cardiovascular disease risk factor levels in children–. The American journal of clinical nutrition. 2013 Oct
23;98(6):1417-24.
[7] Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk factors for falls in people with a lower limb amputation:

a systematic review. PM&R. 2017 Feb 1;9(2):170-80.


[8] Steinberg N, Gottlieb A, Siev-Ner I, Plotnik M. Fall incidence and associated risk factors among people with a lower limb

amputation during various stages of recovery–a systematic review. Disability and rehabilitation. 2018 Mar 14:1-0.
[9] Wong CK, Chihuri ST, Li G. Risk of fall-related injury in people with lower limb amputations: a prospective cohort study.

Journal of rehabilitation medicine. 2016 Jan 5;48(1):80-5.


[10] Barnett, C. T., Vanicek, N., & Polman, R. C. (2013). Temporal adaptations in generic and population-specific quality of life and

falls efficacy in men with recent lower-limb amputations. The Journal of Rehabilitation Research and Development, 50(3), 437.
doi:10.1682/jrrd.2011.10.0205
[11] Hordacre, B., Barr, C., & Crotty, M. (2014). Community activity and participation are reduced in transtibial amputee fallers: a

wearable technology study. BMJ Innovations, 1(1), 10-16. doi:10.1136/bmjinnov-2014-000014


[12] Wong CK, Chen CC, Blackwell WM, Rahal RT. Balance ability measured with the Berg Balance Scale: a determinant of fall

history in community-dwelling adults with leg amputation. Journal of rehabilitation medicine. 2015 Jan 5;47(1):80-6.
[5] Littman AJ, Thompson ML, Arterburn DE, Bouldin E, Haselkorn JK, Sangeorzan BJ, Boyko EJ. Lower-limb amputation and

body weight changes in men. Journal of Rehabilitation Research & Development. 2015 Feb 1;52(2).
[6] Wong CK, Wong RJ. Standard and Amputation-Adjusted Body Mass Index Measures: Comparison and Relevance to

Functional Measures, Weight-Related Comorbidities, and Dieting. American journal of physical medicine & rehabilitation. 2017
Dec 1;96(12):912-5.
[13] Ejtahed HS, Soroush MR, Hasani-Ranjbar S, Angoorani P, Mousavi B, Masumi M, Edjtehadi F, Soveid M. Prevalence of

metabolic syndrome and health-related quality of life in war-related bilateral lower limb amputees. Journal of Diabetes &
Metabolic Disorders. 2017 Dec;16(1):17.
[14] Rouhani A, Mohajerzadeh S. (2013). An epidemiological and etiological report on lower extremity amputation in northwest of

iran. The archives of bone and joint surgery, 121036. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25207299
[15] Johannesson, A., Larsson, G., Ramstrand, N., Turkiewicz, A., Wirehn, A., & Atroshi, I. (2008). Incidence of Lower-Limb

Amputation in the Diabetic and Nondiabetic General Population: A 10-year population-based cohort study of initial unilateral and
contralateral amputations and reamputations. Diabetes Care, 32(2), 275-280. doi:10.2337/dc08-1639
[16] Pooja, G. D., & Sangeeta, L. (2013). Prevalence and aetiology of amputation in Kolkata, India: A retrospective analysis. Hong
Kong Physiotherapy Journal, 31(1), 36-40. doi:10.1016/j.hkpj.2012.12.002
[17] Major, M. J., Fatone, S., & Roth, E. J. (2013). Validity and Reliability of the Berg Balance Scale for Community-Dwelling

Persons With Lower-Limb Amputation. Archives of Physical Medicine and Rehabilitation, 94(11), 2194-2202.
doi:10.1016/j.apmr.2013.07.002
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healthy community-dwelling people: a systematic review. Journal of Physiotherapy, 60(2), 85-89.
doi:10.1016/j.jphys.2014.01.002
[19] Wong, C. K., Chen, C. C., & Welsh, J. (2013). Preliminary Assessment of Balance With the Berg Balance Scale in Adults Who

Have a Leg Amputation and Dwell in the Community: Rasch Rating Scale Analysis. Physical Therapy, 93(11), 1520-1529.
doi:10.2522/ptj.20130009
[20]
Wong CK. Interrater reliability of the Berg Balance Scale when used by clinicians of various experience levels to
assess people with lower limb amputations. Physical therapy. 2014 Mar 1;94(3):371-8.
[12] Wong CK, Chen CC, Blackwell WM, Rahal RT. Balance ability measured with the Berg Balance Scale: a determinant of fall

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