)+
( )
7
Where,
n= The desired sample size
P
1
=Population proportion of ischemic stroke
= 67.9%
= 0.67
P
2
= Population proportion of hemorrhagic stroke
= 32.1%
= 0.32
P= (P
1
+ P
2
)/2
Therefore, P=(0.67+0.32)/2
= 0.495
Putting the values in the above equation the sample size,
*( ) ( )+ ()( )
( )
= 39.00
Therefore, n= 39
So, 78 subjects will be included; 39 will be in each group.
d. Screening
method:
History and clinical examination
e. Sampling
method:
Consecutive sampling
f. Selection of the
patient:
Inclusion criteria:
Patients with hemiplegia due to stroke
within 20-85 years of age.
First episode of stroke.
8
Duration of stroke < 3weeks.
Exclusion criteria:
Seriously co-morbid patients (Like
unconsciousness, recent MI).
Patients having Subarachnoid
hemorrhage.
g. Operational
definitions of
variables:
Operational procedure: On fulfillment on inclusion and
exclusion criteria and after taking informed written
consent, a through history and clinical examination will be
done. All information will be recorded in the data
collection sheet. Disability level will be measured by using
the Barthel index (BI). The BI is considered a reliable
disability scale for stroke patients. It has high inter-rater
reliability, internal consistency, and validity. The index
will be completed through direct observation and self-
report. The items (ADLs) are related to self-care (feeding,
grooming, bathing, dressing, bowel and bladder care, and
toilet use) and mobility (ambulation, transfers, and stair
climbing). (Appendix-05). The response categories of
disability in an activity were defined and rated in scale
steps (0, 5), (0, 5, 10), (0, 5, 10, 15) dependent on the
item. An overall score is formed by adding scores on
each rating. Scores of 0-20 indicate "total" dependency,
21-60 indicate "severe" dependency, 61-90 indicate
"moderate" dependency, and 91-99 indicates slight"
dependency. Then disability scores of ischemic and
hemorrhagic stroke patients will be compared.
h. Flow-chart
showing the
sequence of tasks
Appendix-03
9
i. Procedures of
preparing the
material and
grouping
Patients with hemiplegia will be allocated to two equal
groups: ischemic stroke and hemorrhagic stroke. No
randomization will be applied. All data will be recorded
systematically in Semi-structured questionnaire.
j. Nature of
controls:
Not applicable
k. Randomization
and blinding:
Not applicable
l. Equipment to be
used:
Weight machine, measuring tape, computer, calculator
m. Procedures of
collecting data:
Patients with Hemiplegia within 3 weeks of stroke
attending the OPD of PM&R, CMCH will be registered by
junior post graduate trainee doctors. Then registered
patients will be referred to the investigator. Written consent
will be taken from the patient. Detailed history will be taken
and clinical examination will be done systematically. A pre-
set data form will be filled up for every patient. Patients
with recurrent attack, seriously co-morbid patients,
subarachnoid hemorrhage were excluded to obtain a more
homogenous sample. Information on certain
sociodemographic variables will be obtained from the
patients and/or their caregivers. Impairments during
disability assessment, Non-modifiable risk factors, well-
documented and modifiable risk factors will be recorded.
Area of involvement and type of stroke by CT will also be
recorded.
n. Professional
assistance from
expert:
Assistance will be taken regarding research methodology,
data analysis and collecting information from:
1. Professor (Dr.) Aminuddin A Khan. FCPS
Head, Department of PM&R, CMCH.
2. Dr. Md. Shaik Ahmad FCPS
10
Associate professor, Department of PM&R,CMCH.
3. Dr. Md. Maidul Islam FCPS, MS.
Assistant professor, Department of PM&R, CMCH.
o. Procedure of
data analysis
Data will be analyzed by SPSS (Statistical Package for
Social Sciences) 15 version. Descriptive statistics will be
analyzed to calculate the frequency, percentage, mean
and standard deviation of observed data. Unpaired t test
will be dne. Chi-square or Fishers Exact Probability test
will be applied in order to test the hypothesis for
comparison of data presented in categorical scale. Level
of significance will be set at 0.05 and p < 0.05 will be
considered significant. Important tables, charts and
diagrams will be prepared on the basis of findings relevant
to risk factors, impairments and disability.
p. Quality
assurance
strategy:
It is extremely important that data collection will be of good
quality. In any critical situation expert opinion will be taken
from supervisor and professors of different disciplines.
Data collection sheet will be periodically checked by the
supervisor of the study.
q. Work schedule Appendix-2
15. Ethical
implications
Every respondent will be informed verbally about the design, nature and purpose
of the study according to Helsinki Declaration for Medical Research Involving
Human Subjects 1964. A written consent (Appendix-1) will be taken from the
respondent. There is no involvement of privacy and no chance of physical and
social risks. All the records will be kept under lock & key. Every patient has the
opportunity to receive or withdraw himself/herself from the study at any time.
11
16. Total Budget
1. Personnel cost: Statistician honorarium 5000 BDT
2. Field expenses NA
3. Office items. Files (20), White papers (500),
Pen (10), Calculator (1), Some pencils and
others
20,000
4. Patient costs NA
5. Travel cost NA
6. Printing and reproduction, photocopy,
binding
40,000
7. Contractual services (lab) NA
8. Administrative overhead NA
9. Miscellaneous 5,000
10. Total budget 65,000 BDT
17. Source of
funding
Self-funding
18. Facilities
available at
the place of
study
Chittagong Medical College Hospital is a very renowned and tertiary care
hospital. A large number of patients over the Out-patient department of Physical
Medicine and Rehabilitation is there. It is well equipped and available with
modern treatment options and all necessary pathological and imaging facilities.
19. Other
facilities
needed
Referring the stroke patients from department of neuromedicine and medicine.
20. Disseminatio
n and use of
findings
I long for publishing this study in a quality journal and disseminate the findings. I
hope my findings will play a good role in the field of rehabilitation science and
pave the way of future research.
21. References
1. Hatano S, Experience from a multicentre stroke register: a preliminary
report. Bulletin of the World Health Organisation 1976, 54:54153.
2. MONICA Manual, Part IV: Event Registration. Section 2: Stroke event
registration data component. Office of Cardiovascular Diseases, World
Health Organization; 1999 [cited 16 Oct 2008] [internet] Available from :
http://www.ktl.fi/publications/monica/manual/part4/iv-2.htm.
3. Goldstein M, Barnett HJM, Orgogozo JM, Sartorius N, Symon L,
Vereshchagin NV et al. Stroke--1989. Recommendations on stroke
prevention, diagnosis, and therapy. Report of the WHO Task Force on
12
Stroke and other Cerebrovascular Disorders. Stroke. 1989;20:1407-1431
4. Draa S. Functional recovery of patients after the first-ever unilateral
ischemic or hemorrhagic stroke. Curr top neurol psychiatr relat
discip.2012;XX:1-2.
5. National stroke association. Paralysis August 2012. Available from:
http://www.stroke.org/site/PageServer?pagename=hemiparesis
6. Feigin VL, Lawes CMM, Bennett DA, Anderson CS. Stroke epidemiology:
a review of population based studies of incidence, prevalence, and case-
fatality in the late 20th century. Lancet Neurology 2003;2:4353
7. Mohammad QD, Habib M, Hoque A, Alam B, Haque B, Hossain S et al.
Prevalence of stroke above forty years. Mymensingh Med
J. 2011;20(4):640-4.
8. Sulter G, Steen C and Keyser JD. Use of the Barthel Index and Modified
Rankin Scale in acute Stroke Trials. Stroke 1999, 30:1538-1541
9. World report on disability 2011 (World Health Organization, World Bank).
Available from:
http://whqlibdoc.who.int/publications/2011/9789240685215_eng.pdf
10. World report on disability : World Health Organization, World bank
[internet] 2011. available from:
http://whqlibdoc.who.int/publications/2011/9789240685215_eng.pdf
11. Goldstein LB, Adams R, Alberts MJ, Appel LJ, Brass LM, Bushnell CD, et
al. Primary Prevention of Ischemic Stroke: A Guideline From the
American Heart Association/American Stroke Association Stroke Council:
Cosponsored by the Atherosclerotic Peripheral Vascular Disease
Interdisciplinary Working Group; Cardiovascular Nursing Council; Clinical
Cardiology Council; Nutrition, Physical Activity, and Metabolism Council;
and the Quality of Care and Outcomes Research Interdisciplinary
Working Group: The American Academy of Neurology affirms the value
of this guideline. Circulation 2006;113(24):873923
13
12. Disability: World Health Organization [internet] 2012 .
Available from: http://www.who.int/topics/disabilities/en/
13. World report on disability : World Health Organization, World bank
[internet] 2011. available from:
http://whqlibdoc.who.int/publications/2011/9789240685215_eng.pdf
14. Schepers VPM, Ketelaar M, Visser-Meily AJM, Groot VD, Twisk JWR,
Lindeman E. Functional recovery differs between ischaemic and
haemorrhagic stroke patients. J Rehabil Med 2008;40:487489
15. Mohr JP, Wolf PA, Grotta JC, Moskowitz MA, Mayberg MR, Kummer R
V,Stroke: pathophysiology, diagnosis and management 5
th
edition;
Philadelphia: Saunders, an imprint of Elsevier Inc. 2011:321.
16. Saxena SK, Koh GCH, Ng TP, Fong NP, Yong D. Determinants of
length of stay during post-stroke rehabilitation in community hospitals.
Singapore Med J 2007;48(5):400
17. Salter K, Jutai J, Hartley M, Foley N, Bhogal S, Bayona N et al. Impact
of early vs delayed admission to rehabilitation on functional outcomes in
persons with stroke. J Rehabil Med 2006;38:113-117
18. Paolucci S, Antonucci G, Grasso MG, Bragoni M, Coiro P, Angelis DD et
al.Functional Outcome of Ischemic and Hemorrhagic Stroke Patients
After Inpatient Rehabilitation :A Matched Comparison. Stroke. 2003;
34:2861-2865.
19. Qari FA. Profile of stroke in a teaching university hospital in the western
region. Saudi Medical Journal 2000;21(11):1030-1033
20. Nessa J, Khaleque MA, Begum S, Ahmed AH, Islam MS, Afsan M.
Rehabilitation of Stroke Patients - Effects of Early Intervention of
Physical Therapy on Functional Outcome Bangladesh. Journal of
Anatomy January 2009,7(1):62-67
21. Karkouli G, Kapadohos T. Functional disability of ischemic stroke
patients. To Vima tou Asklipiou 2010;09(2):144-157
14
22. Paciaroni M, Arnold P, Van Melle G, Bogousslavsky J.Severe disability at
Hospital discharge in ischemic stroke survivors. Eur
Neurol. 2000;43(1):30-4.
23. Braddom R, Chan L, Harrast MA, Kowalske KJ, Matthews DJ,
Ragnarsson KT et al. Physical Medicine and Rehabilitation 4
th
edition,
Philadelphia: Saunders, an imprint of Elsevier Inc. 2011:3-40
24. Goljar N, Burger H, Vidmar G, Leonardi M, Marinek , Measuring
patterns of disability using the international classification of functioning,
disability and health in the post-acute stroke rehabilitation setting. J
Rehabil Med 2011:43:590601.
Rahman MS, Shakoor MA, Nahar S, Jahan KS, Uddin MT,
Moyeenuzzaman M et al. Stroke pattern in a private hospital and its
association with two modifiable risk factors- Hypertension and Diabetes
Mellitus. Bangladesh Journal of Neuroscience 2006:22(1):15-20
25.
15
2
22
I solemnly pledge that this research protocol shall be implemented in accordance with
the relevant ordinance of BCPS and funding agencies as and when it may be applicable.
I hereby declare that no part of the proposed research has been used in any
thesis/dissertation in partial fulfillment of any degree/fellowship or any publication.
I also understand that the BCPS reserves the right to accepting or rejecting this protocol.
--------------------------- --------------------------------------
Date Signature of the investigator
Signature of the
supervisor:
Name:
Prof. (Dr.) Aminuddin A. Khan
FCPS (Physical Medicine & Rehabilitation)
Designation:
Professor & Head
Department of Physical Medicine & Rehabilitation
Chittagong Medical College Hospital, Chittagong And
Vice Principal
Chittagong Medical College, Chittagong.
Seal:
16
Appendix-01
Informed written consent
1. Protocol ID:
2. Patients name & ID:
3. Title of the study: Disability assessment of Hemiplegic patients within 3 weeks of stroke.
4. Investigators name: Dr. Md. Nurul Hoque Miah
5. Institution: Department of Physical Medicine & Rehabilitation, Chittagong Medical College
Hospital, Chittagong
6. Purpose of the study: a. To assess the impairments in hemiplegic stroke patients.
b. To compare the level of disability of hemiplegic patients between ischemic & hemorrhagic
stroke.
7. Selection of the participant: Patients will be attended in the Department of Physical Medicine
& Rehabilitation, Chittagong Medical College Hospital, Chittagong
8. Expectation form and involvement of the participant: You will be asked some questions
according to a semi-structured questionnaire that is about your disease. I expect the information
given by you will all be correct.
9. Risk and benefit: There is usually no risk.
10. Privacy, anonymity and confidentiality: We ensure that all information provided by you will be
kept confidential and will be used for the purpose of the study only.
11. Right to withdraw: You are free to take part or withdraw yourself from the study at any time for
any reason what so ever. If you agree to participate in the study, please submit by signing
below.
Thank you for your co-operation
--------------------------------------------
Signature or left thumb impression
of participant
--------------------------------------------
Signature or left thumb impression
of attendant
----------------------------------
Signature of investigator
17
Appendix-02
Time table /work schedule of the dissertation
Name of the
work
July-12 August-12 September-
12
October12 November12 December-12 January-13 February-13 March-13
Selection of
the topic
Literature
review
Selection of
the study
area
Determination
of sample
Development
of instrument
Submission
for finalizing
Data
collection
Data
compilation &
analysis
Report writing
Draft report
submission
Finalizing,
Typing &
binding
Final report
submission
18
APPENDIX-03
Flow-chart showing the sequence of tasks: Disability assessment of Hemiplegic patients
within 3 weeks of stroke.
CT Scan CT Scan
Hemiplegic patients
within 3 weeks of stroke
Patient with H/O recurrent
attack will be excluded
Patient with <20 and >85
yrs will be excluded
Total participants under study
Ischemic stroke Hemorrhagic stroke
Hemiplegic patients of different ages
Subarachnoid hemorrhage
stroke will be excluded
Seriously co-morbid patients will be
excluded
Disability scoring using
Barthel disability index.
Assessment of impairments
Assessment of risk factors
Recording of the
sociodemographic variables
Disability scoring using
Barthel disability index.
19
APPENDIX-04:
DATA COLLECTION SHEET
Department of Physical Medicine and Rehabilitation
Chittagong Medical College Hospital, Chittagong.
Title: Disability assessment of Hemiplegic patients within 3 weeks of stroke.
1. Code no.: Registration no.: Date:
2. Name: Contact no. with mailing address:
3. Age (in Years):
4. Gender: Male= 1 / Female= 2
5. Education: Illiterate=1 / primary=2 / secondary=3 / higher secondary =4 / graduate=5 /
Postgraduate=6 .
6. Occupation: House wife=1 / Service=2 / Farmer=3 / Businessman=4 / Laborer=5 /
unemployed=6 / retired=7 / others=8.
7. Residence: Urban=1 / Semi-urban=2 / Rural=3.
8. Height (in m):
9. Weight (in kg):
10. Number of days from stroke onset:
11. Hemiplegia: yes=1, no=2
12. Hemiplegia side: Right=1/ left=2
13. Spasticity: yes=1, no=2
14. Speech abnormality yes=1, no=2
15. Incontinence of bowel : yes=1, no=2
16. Incontinence of bladder: yes=1, no=2
17. Dysphagia: yes=1, no=2
18. Visual field defect : yes=1, no=2
19. Sensory involvement : yes=1, no=2
20. Apraxia : yes=1, no=2
21. Hemi neglect syndrome=1, no=2
22. Other impairmens:
20
23. Risk factors(modifiable): Hypertension =1/ Hyperlipidemia=2 /Diabetes mellitus =3/
Ischemic heart disease =4/ Valvular heart disease =5/ Smoking =6/ Physical inactivity=7/
Stress=8 /Prior TIA=9/ postmenopausal hormone therapy=10/ Others=11.
24. Risk factors(non-modifiable): Age (after 55 years)=12/ positive family history=13/H/O
previous stroke or heart attack=14 /Gender (men)=15
25. CT findings: Supratentorial=1/ Infratentorial=2
26. The Barthel Disability Index scoring:
"total"
dependency(0-20)
"severe"
dependency(21-60)
"moderate"
dependency (61-90)
"slight" dependency
(91-99)
First contact
(within 3
weeks of
stroke)
21
APPENDIX 05
THE BARTHEL DISABILITY INDEX
FEEDING
0 = unable
5 = needs help cutting, spreading butter, etc., or requires modified diet
10 = independent
BATHING
0 = dependent
5 = independent (or in shower)
GROOMING
0 = needs to help with personal care
5 = independent face/hair/teeth/shaving (implements provided)
DRESSING
0 = dependent
5 = needs help but can do about half unaided
10 = independent (including buttons, zips, laces, etc.)
BOWEL
0 = incontinent (or needs to be given enemas)
5 = occasional accident
10 = continent
BLADDER
0 = incontinent, or catheterized and unable to manage alone
5 = occasional accident
10 = continent
TOILET USE
0 = dependent
5 = needs some help, but can do something alone
10 = independent (on and off, dressing, wiping)
TRANSFERS (BED TO CHAIR AND BACK
0 = unable, no sitting balance
5 = major help (one or two people, physical), can sit
10 = minor help (verbal or physical)
15 = independent
MOBILITY (ON LEVEL SURFACES)
0 = immobile or < 50 yards
5 = wheelchair independent, including corners, > 50 yards
10 = walks with help of one person (verbal or physical) > 50 yards
15 = independent (but may use any aid; for example, stick) > 50 yards
22
STAIRS
0 = unable
5 = needs help (verbal, physical, carrying aid)
10 = independent TOTAL (0100):
Administration and Scoring:
The response categories of disability in an activity were defined and rated in scale steps (0, 5),
(0, 5, 10), (0, 5, 10, 15) dependent on the item
25
.
An overall score is formed by adding scores on each rating
26
. Scores range from 0 to 100, in
steps of 5, with higher scores indicating greater independence. The maximal score is 100 in 5-
point increments, indicating that the patient is fully independent in physical functioning. The
lowest score is 0, representing a totally dependent bedridden state
16,25
.
Interpretation of scores:
Several authors have proposed guidelines for interpreting Barthel scores. Shah et al.
suggested that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency,
61-90 indicate "moderate" dependency, and 91-99 indicates slight" dependency
25
.