RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1 / NAME OF THE CANDIDATE AND ADDRESS / Mr. RAM KRISHNA ACHARYA
c/o Dirgha Raj Acharya
House no 15,Sugam marg,Masbar,Pokhara-7,
Nepal
2 / NAME OF THE INSTITUTION / THE OXFORD COLLEGE OF PHYSIOTHERAPY
J.P. Nagar, 1ST Phase,
Bangalore,560078
3 / COURSE OF THE STUDY AND SUBJECT / MASTER OF PHYSIOTHERAPY
(NEUROLOGICAL AND PSYCHOSOMATIC DISORDERS)
4 / DATE OF THE ADMISSION TO THE COURSE / 26-05-2008
5. / TITLE OF THE STUDY
“A LONGITUDINAL STUDY OF RECOVERY OF MOTOR FUNCTION AND PREDICTING FUNCTIONAL INDEPENDENCE IN PEOPLE WITH STROKE.”
6. / BRIFE RESUME OF INTENDED WORK:
6.1 NEED OF THE STUDY:
A primary concern immediately after stroke, for patients, their relatives and care givers is the prospect for recovery. But the exact recovery pattern of motor function following stroke is not known1
Despite recovery stroke is a leading cause of disability for aged population, with more than 50% of population being left with residual motor deficit.2 AB Tally after studying the Indian population sates during first week of stroke 78-90% patients are dependent in some aspects of ADL and by one year 33-59% continue3 to remain dependent 3
Dependency in activities of daily living (ADL) after stroke is primarily determined by degree of motor function impairment.4,5, with knowledge of motor function the dependency level of ADL in stroke patients can be estimated with minimum error 4,6
Recovery of motor function is maximal in first week, slows down after 2 or 3 months and probably stops at 6 to 12 months post stroke7, 8
Previous studies on recovery demonstrates variable nature of motor recovery influenced by number of factors.9-12 Some patients experience the better recovery in upper extremity function but the poor lower extremity and vice versa. With the kind of variable recovery pattern it is important to document the recovery of upper extremity, lower extremity, trunk and balance to determine overall motor function which explain 85% of variance in outcome of ADL.13
Previous studies on ADL of people with stroke found the strong correlation
between each of the motor function with ADL and while predicting the functional independence only one function has been taken into consideration.11,14-19
By taking in account of all motor function recovery pattern into consideration we can be more precisely predict the functional independence. But the studies has not been done in this area hence the study is undertaken
1. for finding the recovery pattern of motor function following stroke
2. for establishing the role of each motor function in predicting functional ability of the people with stroke.
6.2 REVIEW OF LITERATURE:
STROKE DEFINITION AND PREVALENCE
1. WHO(1988)20- has defined stroke as focal neurological impairment of sudden onset and lasting more than 24 hours and of presumed vascular origin sequels deriving from this event may lead to sever deficits.
2. PK Sethi (2002) 21- in his paper, Stroke –Incidence in India and management of ischemic stroke states the prevalence of stroke in India was estimated as 203 per 100,000 population above 20 years.
3. R Bonita and R Beaglehole4 (1988)22 did a large population study and found 88% of all people in a community based stroke register had motor deficit.
ADL IN STROKE
4. KPS Nair, AB Tally (2002)3- states that during first week of stroke 78- 90 % patients are dependent in some aspects of ADL. And by one year 33- 59% continue to remain dependent.
5. Med term (2008)23 defines ADL as the thing we normally we do in daily living including any activity we prefer for self care (such as feeding ourselves, bathing, dressing, grooming) work, house making and leisure. The ability or inability to perform ADL can be used as a very practical measure of ability/disabilities in many disorders.
RECOVERY AFTER STROKE
6. Jorgensen H, Reith T, Nakayama H, et al (1999)10 conducted studies to determine factors which determines good functional recovery and concluded decreasing age, spouse at home; spontaneous body temperature and early neurological recovery are related to good functional outcome.
7. Gert V, Alice N, Liesbe DW, et al (2005)7 conducted a study to examine the patterns of recovery trunk, arm leg and functional ability from 1 week to61 month after stroke and found most improvement occurred from 1 week to 1 month after stroke. No statically significant recovery found from 3 months to 6 months.
MOTOR FUNCTION AND ADL
8. Ozlincler R Arzu (2005)4 conducted a study on stroke inpatients and states motor function impairment is the major factor for dependency in ADL.
9. Binkofski F, Seitz RJ, Hoclonder T, et al (2001)12 states a relative improvement of the initial motor score of about 20% in the first 4 week after stroke appeared to be a relevant cut point for good outcome.
10. Lowen SC, Anderson BA (1990)13 conducted study on acute stroke patients and concluded that 85% of variance in outcome of ADL was explained by motor function.
11. Berg KO, William JI, et al (1992)16 their studies show that there exits a very high relation between balance and ADL in stroke patients.
RELIABILITY AND VALIDITY OF OUTCOME MEASURES
12. Tyson SF, Desouza LH, (2004)24 conducted a study to check reliability and validity of Berg Balance scale and concluded that Berg Balance Scale is reliable and valid for measuring
functional balance in stroke patients.
13. Barreca SR, Stratfrod PW, Lambert CL, et al (2005)25 compared Chedoke Arm Hand Activity Inventory (CAHAI) with Chedoke McMaster Stroke Assessment (CMSA) and Action Research Arm test and found that CAHAI test permits a more accurate and relevant measure of clinical change.
14. Verheyden G, nieuwboer A, Liesbet DW, et al (2006)14 recommended trunk impairment scale as a prediction instrument in the rehabilitation setting when considering the prognosis of stroke patients.
15. A Shumway Cook, M Woollcott (1995)26 stated that gait disability is one of the disabilities in stroke which constitute about 65%. In carrying out ADL and instrumental activities of daily living (IADL) task, the average person walks approximately 300m.
16. A Shumway cook, Brauers S, Woollacott M, (2005)27 conducted a study in community dwelling older adults and states the time up and go test is the easy to carry out and reliable test of functional mobility which can be used in predicting falls.
17. Sangha H, Lipson D (2005)28 studied a comparison of Barthel
index (BI) and functional independence measure (FIM) as an outcome measure in
stroke. Results showed that Barthel index was used more often than FIM and was
sited in trial of superior quality.
7. / 6.3 OBJECTIVE OF THE STUDY:
1.  To document the recovery pattern of motor function after stroke.
2.  To identify the role of motor function in predicting the functional independence following stroke.
6.4 HYPOTHESIS:
(A) RESEARCH HYPOTHESIS:
Initial motor function can predict the functional independence.
(B) NULL HYPOTHESIS:
Initial motor function can not predict the functional independence.
MATERIALS AND METHODS:
7.1 STUDY DESIGN AND SETTING:
7.1.1 STUDY DESIGN:
A longitudinal study.
7.1.2  SOURCE OF DATA:
Acute care hospitals in and around Bangalore.
7.2 METHODOLOGY
7.2.1 POPULATION:
Both male and female subjects diagnose with stroke duration of less than 1 week age group of 40 to 65 who satisfy the selection criteria from the population of study.
7.2.2 SELECTION CRITERIA:
a) INCLUSION CRITERIA.
In order to participate in the study, subjects must satisfy the following criteria.
Screening test: Mini Mental State Examination- a test of cognitive function has 30 point scale. Patients should score 24 or above to carry on with study.
1. First ever stroke
2. Stroke duration of less than 1 week.
3. age 40 to 65 years
4. Both genders.
5. Subjects residing in or around Bangalore.
6. Medically stable and referred to physical therapy by attending physician or neurologist.
7. Patients with mini mental state examination score of 24 or more.
8. The patients should be able to stand at least with support.
b) EXCLUSION CRITERIA:
Subjects will be excluded from this study if any of following criteria apply
1. Patients with major medical co morbidities e.g. amputation, sever chronic obstructive pulmonary disease, sever arthritis.
2. Recent or old fractures and other musculoskeletal disorders affecting extremity functions.
3. Patients with behavioral disturbances and psychologically non cooperative.
4. Patients with hearing and visual impairment
5. Patients with cognitive impairments
6. Subjects with previous history of stroke attack.
7. Cardiac surgery or a myocardial infraction with in last 3 months.
c) Withdrawal criteria
1)  Those patients who don’t want to continue participating in the study.
2)  Those patients who shifted their residence to some other place from Bangalore and not possible to follow up.
3)  Those who developed disabling complication during the study.
7.2..3 SAMPLING:
(A) Sampling Method:
Convenient sampling
(B) Sample size:
n= 50, people with stroke who fulfills the inclusion criteria and does not apply the exclusion criteria.
7.2.4 PROCEDURE:
Ø  Patients from the different centers will be invited to participate in this study .subjects will be selected through selection criteria. Informed consent form the form from the subject will be obtained. The purpose and the procedure of the study will be explained.
Ø  Demographic data, contact address and contact number will be collected for follow up.
1.  Upper extremity function will be recorded on chedoke arm hand inventory scale.
2.  Trunk function will be recorded on trunk impairment scale.
3.  Lower limb function will be recorded on time up and go test.
4.  Balance will be recorded on berg balance scale.
5.  Functional independence will be measured on barthel index.
Ø  Four set of longitudinal data will be collected
Ø  1st with in 1st week after stroke
Ø  2nd after 1 month
Ø  3rd after 2 months after stroke
8. / Ø  3rd after 2 months after stroke
Ø  4th after 3 months after stroke
Ø  Data will be analyzed using appropriate statistical analysis.
a) DURATION OF STUDY
4 days during the period of 3 months.
(b) MATERIAL USED:
1) For MMSE..
1)  Pen
2)  Paper
3)  Pencil
4) Any three objects (table,watch,cup)
2) For Barthel index.
1)  Walking aids
3) For Berg Balance Scale
1) stool with back support
2)  Step stool
3)  Ruler
4)  Stop watch
5)  Slipper
6)  Inch tape.
4) For CAHAI
1)  A jar of coffee
2)  Mobile set
3)  Toothpaste
4)  Toothbrush
5)  Medium consistency putty
6)  Eye glass
7)  Zipper
8)  Towel
9)  Container
10) Table
11) Bag
5) For Time up and go test
1)  Arm chair
2)  Tape measure
3)  Stop watch
6) For TIMS
1.  stool
2.  bed
7.3 OUTCOME MEASURES AND STATISTICAL ANALYSIS
7.3.1 OUTCOME MEASURES: (ATTACHED AT APPENDIX)
1.  Chedoke arm hand activity inventory25,29
2.  Trunk impairment scale14,30
3.  Berg balance scale24,31,35
4.  Time up and go test27,32,34
5.  Barthel index13,28,33
7.3.2  STATISTICAL ANALYSIS
Descriptive statistics for describing recovery pattern
Multiple regression
Logistic regression
7.4 (a) Does the study requires any interventions to be conducted on patients or other humans or animals?
Yes, motor function of study population will be evaluated based on specified scales.
(B) Has the ethical consent for the study has been obtained from the institution?
Yes, it has been obtained from the Ethical clearance from is attached as appendix (II). An informed consent will be obtained prior to study in their native.
REFFERENCES:
1)  Kate Tilling, Jonathan ACS, Anthony GR, Thomas AG, Robert JW, Charles DAW. A new method for predicting recovery after stroke, Stroke-2001;32;2867-73
2)  Duncan PW, Goldstein LB, Matchar D, Divine GW, Feussner J. Measurement of motor recovery after stroke: outcome assessment and sample size requirements; stroke,1992;23:1084-89
3)  KPS Nair, AB Tally. Stroke rehabilitation: traditional and modern approaches, Neurology India ,2002; 50: 85-93
4)  OR Arzu. Research paper, Journal of medical science; 2005;3;189-94
5)  O Sullivan SB, Thomas JS. Physical rehabilitation: Assessment and Treatment, 4th ed. Jaypee Brothers Medical publishers; New Delhi;2001; P.539
6)  Ozdincler RA, Ersoz B. What is the relation between motor function assessment outcome and ADL after stroke?; Journ of Med. Sciences;2005;3;189-194
7)  Alice N,Liesbet DW, Vincent T, Dobbelaere J, devos h, Deborah S, et al. Neurorehabil Neural Repair,2008;222;173-179
8)  Donaghy M. Brains disease of the nervous system, 11th ed.Oxford university press Inc.,2001;P. 844-45.
9)  Leeanne MC, Daid FA, Gary FE, Julie, Geoffrey AD. Motor impairment and recovery in upper limb after stroke: behavioral and neuroanatomical correlates,Stroke;2005;36:665-29
10) Henrik SJ, Jokob R, Hirofumi N, Lars PK, Habs OR, Oslen TS. What determines good recovery in patients with the most severe stroke? : The copenhagan stroke study; Stroke ; 1999;30;2008-12
11) Heller A, Derick Tw, Victoriua AW, et al. Arm function after stroke: measurement and recovery over the first three months, Journal of Neurology, Neurosurgery and Psychiatry,1987;50;714-714
12) Newman M . The process of recovery : After hemiplegia ;Stroke; 1972;3;702-10
13) Lowen SC, Anderson BA. Reliability of the modified motor assessment scale and barthel index; Physical therapy;1988;68;1077-81
14) Verheyden G, Nieuboer A, Liesbet DW;et al; Trunk performance after stroke : an eye cathing predictor of functional outcome; Clinical Rehabil;2006;20;5;451-58
15) Alexander W.et al .Relationship between upper limb functional limitation and self reported disability 3 months after stroke; Journal of rehabilitation and research development;2006;43-3
16) Berg KO, Williams Ji, et al. Measuring balance in elderly : validation of an instrument ;Canadian Journal. of Public Health;1992;83-sup:7-11
17) Harry KM Lee, Rhonda J Scudds.Comparision of balance in older people with and with out visual impairment, Age Ageing; 2003;32;643-49
18) Margaret KH, James T. Robertson. The American heart association stroke outcome classification;Stroke;1998;29;1274-1280
19) Harris JE, Eng JJ. Paretic upper limb strength best explain arm activity in people with stroke, Physical therapy,2007,87;88-97
20) WHO. The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration.WHO MONICA Project Principal Inestigators;Journal of Clinical Epidemiology 1988;41;105-114
21) PK Sethi. Stroke incidence in India and management of ischaemic stroke, Neurosciences ; 2002 ; 3 : 139-43
22) R Bonita, R Beaglehole. Recovery of motor function after stroke;Stroke1988;19;1497-1500
23) Medterms;definition of ADL (activities of daily living) (online) 2008(cited no 17,2008) available from URL http//:www.medterms.com
24) Tyson SF, Desouza LH. Rliability and validity of functional balance test post stroke; Clincal Rehabil;2004;dec18;916-23
25) Barreca SR, Stratord PW,Lambert CL,Master LM,Streiner DL. Test – retest reliability and sensitivity of the chedoke arm hand activity inventory: a measure of upper limb function for survivors of stroke; Arch Phys Med Rehabil;2005;86;1016-22
26) A-shumway cook, M Woollacott. Motor control theory and practical application; 1995, 1st ed. P. 317.
27) A-shumway cook, M Woollacott, Brauers. Predicting the probability for falls in community-dwelling older adults using the time up and go test, Physical Therapy;2000;80;896-903
28) Sangha H, Lipson D, Foley N , Salter K. A comparison of the barthel index and the functional independence measure as outcome measures in stroke rehabilitation: patterns of disability scale usage in clinical trails, Int journal of Rehabil;2005;jun;28;135-9
29) Barrea S, Gowland CK, Stratford p, Huijbregts M, Griffiths J, Torresinw,et al. development of the chedoke arm hand activity inventory: theorical constructs, iterm generation and selection, Top Stroke Rehabil;2004;11;31-42
30) Ozdincler RA, Ersoz B. What is the relation between motor function assessment outcome and ADL after stroke?; Journ of med. Sciences;2005;3;189-194
31) Shigeru Usda,Kazufumi Arya. Construct validity of functional balance scale in stroke patients;Journal of Physical Therapy Sciences.;1998;10;153-56
32) Podsiadlo D, Richardson S; The time up and go test , a test of basic functional mobility for frail elderly persons, Journ of the American Geriatrics Society ;1991;39;142-148
33) Mohoney F,Barthel D. Functional evaluation : the barthel index , Maryland State Medical Journal;1965;14;56-61
34) Hui-CW, Ng SS. The timed up and go test : its reliability and association with lower limb impairments and locomotor capacities in people with stroke, Arch Phys Med Rehabil ; 2005; 86: 1641-47
35) L Blum, NK Bitensky. Usefulness of the berg balance scale in stroke rehabilitation : a systemic review; Physical Therapy ; 2008;88;559-66
9. / Signature of the candidate / RAM KRISHNA ACHARYA
10. / Remarks of the guide
11. / NAME AND DESINGNATION OF THE
GUIDE
11.1 Guide / Mr. R.Vasanthan, MPT
Assistance professor
11.2 Signature
11.3 Co-guide
11.4 Signature
11.5 Head of the
Department / Mr. R. Vasanthan , MPT
Assistance professor
11.6 Signature
12. / 12.1 Remarks of chairman
and principal
12.2 Signature / Mr. K. G. Kirubakaran
Principal

APPENDIX-I