A Cross Sectional Study

RESEARCH PROPOSAL

A STUDY TO DETRMINE THE FUNCTIONAL INDEPENDENCE, QUALITY OF LIFE, COMMUNITY REINTEGRATION AND REHABLITATION CHALLENGES OF POST DIACHARGESTROKE PATIENTS FROM A TERTIARY HOSPITAL IN MANGALORE.

-A CROSS SECTIONAL STUDY

MASTER OF PHYSIOTHERAPY IN NEUROLOGICAL AND PSYCHOSOMATIC DISORDERS

MS. SHETTY NISHITA PRABHAKAR

DEPARTMENT OF PHYSIOTHERAPY

FR. MULLER MEDICAL COLLEGE

MANGALORE-575002

Rajiv Gandhi University of Health Science, Karnataka, Bangalore

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / Ms. SHETTY NISHITA PRABHAKAR
2. / NAME OF THE INSTITUTE / FATHER MULLER MEDICAL COLLEGE MANGALORE
3. / COURSE OF THE STUDY / MASTER OF PHYSIOTHERAPY IN NEUROLOGICAL AND PSYCHOSOMATIC DISORDERS ( MPT-NPD)
4. / DATE OF ADMISSION / 1-06-2011
5. / TITLE OF THE TOPIC / A STUDY TO DETRMINE THE FUNCTIONAL INDEPENDENCE, QUALITY OF LIFE, COMMUNITY REINTEGRATION AND REHABLITATION CHALLENGES OF POST DIACHARGE STROKE PATIENTS FROM A TERTIARY HOSPITAL IN MANGALORE. -A CROSS SECTIONAL STUDY
6.
7.
8. / BRIEF RESUME
6.1 NEED FOR THE STUDY:
Stroke is the major cause of disability worldwide.1There is burden of disability due to stroke hence much of post-stroke care relies upon rehabilitation interventions.2
Stroke patients are discharged from hospital when they are medically stable3. Most of the Developed countries like United Kingdom, Southwest Stockholm, and Sweden follow early supported discharge (ESD)4,5. Length of hospital stay of acute stroke patients varies from 6 -11 days,6and are referred to either of the following, inpatient rehabilitation unit, outpatient physiotherapy, community rehabilitation centres, and domiciliary rehabilitation. Though the interdisciplinary inpatient stroke rehabilitation unit’s remains the gold standard of care in stroke rehabilitation, access to them is limited.7So some patients are advised for home based care by multidisciplinary professional8 and those who are able to ambulate are usually referred to outpatient physiotherapy services or community rehabilitation centres.
ESD reduces the cost burden of conventional hospital rehabilitation faced by the patient. Such schemes have been shown to reduce the length of hospital stay by 13 days, with no negative effect on patient’s quality of life and are safe and acceptable to families and patients with stroke.9
A different picture is seen in developing countries. The mean length of hospital stay for stroke patients in a recent study done in North India is 10 ± 6 days10. This duration is similar to that of developed countries. Early discharge of stroke patients who are medically stable is followed here with advice of home exercise.
Stroke patient’s shows good recovery in first six months and physiotherapy during this time is invaluable for their recovery. Physical therapy is important in acute phase post stroke,and it is suggested that early implementation of physical therapy is associated with enhanced and faster improvement of functional recovery after stroke11,. For these hardly there are any community rehabilitation facilities in this region. Only patients who are economically sound can afford expenses of domiciliary rehabilitation. Any government support does not exists for stroke rehabilitation12.
Early benefits achieved in an acute stroke unit may decline due to inadequate rehabilitation after discharge. Hence, it’s the need of the time to consider what happens to stroke patients post discharge. Little is known in this aspect. Hence this study aims to evaluate the functional status of stroke patients at the time of discharge and 3 weeks later. Functional status in stroke patients is associated with quality of life and community reintegration.13,14 This study aims at correlating the outcome of functional status 3 weeks post discharge with quality of life and community reintegration. At discharge patients are advised to exercise at home, hence study aim’s to evaluate the practice of exercise by the patient in their home and to identify to what extent they were able to reintegrate to normal life.
The post stroke patients are facing lot of rehabilitation challenges like low family income, lack of financial fund, lack of rehabilitative services within the area of leaving, lack of transport facility15. Rehabilitation challenges vary according to region and limited data is available regarding rehabilitation challenges of stroke patients particular to this region. Hence we also intent to identify the rehabilitation challenges of post stroke patients.
FIM assess the functional aspects of stroke disability, it’s is a valid and reliable measure that is useful in both acute care and in rehabilitation settings.16 Stroke specific quality of life has good criterion validity for all subsets of stroke. Because it consists of only 12 questions, this short form will be easy to use in research and clinical settings17. Modified reintegration to normal living index, a reliable and valid scale to evaluate the community participation of stroke patients.18 The barriers in rehabilitation can be assessed through the instrument, Barriers to Physical Activity and Disability Survey formed by national centre on physical activity and disability which has good test retest stability15.
RESEARCH QUESTION:
Is there a significant difference between functional independence of stroke patients at discharge with 3weeks post discharge?
Is there a correlation between functional status of stroke patients 3 week post discharge with quality of life and community reintegration?
What are the rehabilitation challenges of stroke patients?
RESEARCH/ALTERNATE HYPOTHESIS:
There will be a significant difference between functional independence of stroke patients at discharge and 3 weeks post discharge.
There will be a significant association of functional independence with quality of life and community participation at 3 weeks post discharge in stroke patients.
NULL HYPOTHESIS:
There is no significant difference between functional independence of stroke patients at discharge and 3 weeks post discharge.
There is no significant association of functional independence with quality of life and community participation at 3 weeks post discharge in stroke patients.
6.2 REVIEW OF LITRATURE:
Functional independence at discharge:Plante M, et.al had assessed 111 stroke patients for independence in daily activities at discharge, using the Functional Autonomy Measurement System (SMAF) 2002 revised version SMAF for a maximum score of −87, a large negative score indicates reduced independence in daily activities. The score at discharge in this study was -16.9/-63 indicating moderate losses in independence14.
Functional independence Post Discharge:Mayo N E, et al had done a 2 years follow up study in which 434 persons with stroke were evaluated for basic ADL using Barthel Index at an interval of approximately 6 months post stroke, the group scored on average 90.6/100 on the Barthel Index; 39% reported a limitation in functional activities at 6 month evaluation19.
Quality of life Post Discharge:Mayo N E, et al had done a 2 years follow up study in which 434 persons with stroke were evaluated for quality of life using Health Related Quality of life at an interval of approximately 6 months post stroke, HRQOL (SF-36) mean data estimated were Physical functioning 63.4, Role–physical (range, 0–100) 53.0, General health (range, 0–100) 68.9, Social functioning (range, 0–100) 75.4, QOL (QOL-VAS) 6.819.
Community reintegration post discharge: Mayo N E, et al had done a 2 years follow up study in which 434 persons with stroke were evaluated for community participation using reintegration to normal living index at an interval approximately 6 months post stroke, on the RNL Index, a measure of participation, only 35% of the stroke cohort was independent in all 11 areas (65% reported restrictions) most problematic were travel, social activities, recreational activities, moving around the community, and having an important activity to fill the day, for which 36% to 41% reported some difficulty19.
Association of functional independence with community reintegrationpost discharge:
Plante M, et.al had assessed 111 stroke patients independence in daily activities at discharge from rehabilitation and the degree of community reintegration at 6 months later following discharge showing that independence in daily activities was associated with the community reintegration14.
Chau P C J, et al had assessed the participation restriction off 188 stroke patients at 12 months discharge using London handicap scale and found functional ability has the largest anddirect effect on participation restriction among stroke patients20.
Association of functional independence with quality of life post discharge:Sarma P S, et.al. had done a study on stroke patients with the sample size of 162in the year 2010 in India and concluded that functional dependence were associated with impaired quality of life13.
Reintegration to normal living after discharge: Wood P J; et.al. had done a qualitative study on stroke patients with a sample size 10, regarding community reintegration over the first year following stroke through interview method assessed before discharge and in their homes at two weeks, three months, six months and one year post discharge, Concluding that community reintegration after stroke involved transitioning through a series of goals: gaining physical function, establishing independence, adjusting expectations and getting back to real living21.
Rehabilitation challenges faced by stroke patients post discharge:Moreland J D, et al had done a study on stroke patients regarding the need for assessments in stroke patients post hospital discharge using interview survey method on a sample size of 209 stroke patients in the year 2009 showed numerous number needs and barriers faced by stroke patients, in the aspect of physical impairments, time for recovery, therapies and services, family support, mobility, ADL, finances, communication and employment, social participation, environments and limited services22.
Outcome Measures Reliability validity and use in stroke:
Functional Independence Measure:In the year 2010 Chumney D, et al. had done a systemic review on the use of 18 items FIM scale to assess the stroke patient's degree of disability and functional independence. Through their search strategies 18 studies using FIM for evaluating functional independence were considered of which only 6 studies with the PEDro score 5 and above and where accepted. The study concluded that the thirteen items of the scale define disability in motor functions and five define disability in cognitive functions and is widely utilized for evaluating independence in stroke patients23.
Mackintosh S had done an Appraisal Clinimetrics on FIM through literature search and reported that Ottenbacher et al (1996) had performed a meta-analysis of 11papers investigating reliability of the FIM and they concluded that the median correlations coefficients between total scores was equal to 0.95 for inter-rater reliability, 0.95 for test retest reliability, and 0.92 for equivalence reliability24.
Stroke Specific Quality Of Life:Marcel W M, et al had done a study on validity of short version of stroke specific quality of life in the year 2011 with a sample size of 141 patients and concluded that this scale has good criterion validity for all subsets of stroke. Because it consists of only 12 questions, this short form will be easy to use in research and clinical settings17.
Modified Reintegration to normal living:Miller A, et al had done a study on community dwelling adult rehabilitation population with a convenience sampling from outpatient rehabilitation services on a sample size of 46 adults, The mRNL Index demonstrated acceptable internal consistency (Cronbach's α = 0.80), as did Test-retest reliability was also acceptable (intra class correlation coefficient (3,1) = 0.83, p = .0001)25.
Daneski K, etal had done a study stroke with a sample size of 26 The modified RNLI correlated positively with related scales, with test and retest and seven items substantial agreement of (kappa= >0.61), and concluded that modified reintegration to normal living index is a reliable and valid scale to evaluate the community participation of stroke patients18.
Barriers to physical activity and disability questioner:Rimmer J H, et al had done a retrospective analysis on stroke patients and concluded that there are various challenges faced by the stroke patients and the barriers in rehabilitation can be assessed through the instrument, Barriers to Physical Activity and Disability Survey formed by national centre on physical activity and disability which has good test retest stability15.
6.3 OBJECTIVES OF THE STUDY:

• To identify the difference between functional status of stroke patients at discharge with 3weeks post discharge
• To assess the quality of life and community reintegration of stroke patients 3weeks post discharge
• To correlate the functional independence at 3 weeks post discharge with quality of life and community reintegration.

• To identify the rehabilitation challenges faced by stroke patients post discharge.

MATERIALS AND METHODS
7.1 SOUTCE OF DATA:
First time stroke patients admitted and discharged from Father Muller Medical College Hospital ( FMMCH).
7.2 METHOD OF COLLECTION OF DATA:
STUDY DESIGN
Cross- sectional study
SAMPLE PROCEDURE AND SIZE:
Convenience consecutive sampling of stroke patients admitted in FMMCH will be recruited.
INCLUSION CREITERIA

• Stroke patients at discharge
• Age 45-65 yrs.
• First episode of stroke
• No neurological deficit prior to stroke
• Patient ambulating and independent in self-care prior to stroke

EXCLUSION CRITERIA

• Recurrent episode of stroke
• Subject with any prior musculoskeletal dysfunction

OUTCOME MEASURES – TOOLS:
Functional independence:- FIM
Quality of life:- short version of Stroke specific Quality of life
Community reintegration:- The modified Reintegration to Normal Living Index (RNLI)
Rehabilitation challenges in stroke : Barriers to physical activity and disability questioner
METHOD OF THE STUDY:
Patients who are admitted in Father Muller Medical college hospital and are referred for physiotherapy will be included in the study. Stroke patients who are referred for physiotherapy will receive routine regular Physiotherapy during inpatient phase in the presence of caregivers. At discharge, patient and caregiver will receive education regarding home exercise. With their agreement in the informed consent form, they will be considered for the study, and their functional independence at the time of discharge will be measured using FIM
Three weeks post discharge functional independence, quality of life, and reintegration to community will be assessed during their follow up visit to the hospital or by visiting their home, using FIM, stroke specific quality of life, and modified reintegration to normal living. Rehabilitation challenges/barriers faced by them will be assessed using Barriers to physical
activity and disability questioner designed to evaluate rehabilitation challenge in stroke patients.The functional independence outcome at discharge will be compared to the functional independence outcome 3 weeks post discharge
The 3 weeks post discharge functional independence will be correlated with quality of life and community reintegration.
STATISTICAL ANALYSIS:
Data analysis will be done using Mean, Standard Deviation, Frequency percentage, Wilcoxon Signed Rank Test, and Karl Pearson's co- efficient of correlation, Chi Square Test.
7.3 Does the study require any investigation or intervention to be conducted on patients
No
7.4 Has Ethical clearance been obtained from your institution in case of 7.3
Yes, attached here with
LIST OF REFRENCES:
1. Donnan A G, Fisher M, Macleod M, Davis M S. Stroke. The Lancet. Volume 371, Issue 9624, Pages 1612 - 1623, 10 May 2008.
2. Langhorne P, Legg L. EVIDENCE BEHIND STROKE REHABILITATION. J Neurol Neurosurgery Psychiatry 2003;74, Suppl IV, iv18–iv21
3. Rasmussen H P, Wendel K. Early Supported Discharge after stroke and continued rehabilitation at home coordinated and delivered by a stroke unit in urban area. J Rehabil Med 2009; 41: 482–48.
4. Anderson C, Mhurchu C N, Rubenach S, Clark M, Spencer C, Winsor A. Home or Hospital for Stroke Rehabilitation? Results of a Randomized Controlled Trial : II: Cost Minimization Analysis at 6 Months. Journal of the American heart association. Stroke 2000, 31:1032-1037.
5. Koch L V, Holmqvist L W, Kostulas V, Almazan J, Cuesta. J P. A randomized controlled trial of rehabilitation at home after stroke in Southwest Stockholm. Scand J Rehabil Med. 2000 Jun;32(2):80-6.
6. Bhatt H, Rizvi A A. Average Inpatient Glucose Levels during the first 72 hours, Clinical Outcomes, and Length of Hospital Stay in Patients with Acute Ischemic Stroke.Int J Diabetes & Metab (2010) 18:13-17.
7. Teasell R, Meyer J M , McClure A, Pan C, Fernandez M M, Foley N, Salter K. Stroke Rehabilitation: An International Perspective. Top Stroke Rehabil 2009;16(1):44–56.
8.Langhorne P, Holmqvist L W. EARLY SUPPORTED DISCHARGE AFTER STROKE. J Rehabil Med 2007; 39: 103–108
9. Craig Anderson C, Mhurchu C N, Brown P M, Carter K. Stroke Rehabilitation Services to Accelerate Hospital Discharge and Provide Home-Based Care An Overview and Cost Analysis.Pharmacoeconomics 2002; 20 (8): 537-552, 1170-7690/02/0008-0537.
10.Pandian D J, Kaur A, Jyotsna R, Sylaja N P, Vijaya P, Padma V M, Venkateswaralu K, Sukumaran S, Mathew R, Kaur P, Singh Y, Radhakrishnan K. Complications in Acute Stroke in India (CAST-I): A Multicenter Study. Journal of Stroke and Cerebrovascular Diseases. Vol.2011: pg 1-9.
11 Huanga H C, Chungb K C, Laia D C, Sungc S F. The Impact of Timing and Dose of Rehabilitation Delivery on Functional Recovery of Stroke Patients.Journal of the Chinese Medical Association Volume 72, Issue 5, May 2009, Pages 257-264.
12. Mishra. N K, Patel H, Hastak S M, “Comprehensive stroke care: an overview” J Assoc Physicians India. 2006 Jan; 54:36-41.
13. Raju R S, Sarma P S, Pandian J D. Psychosocial Problems, Quality of Life, and Functional Independence Among Indian Stroke Survivors. Journal of the American heart association.Stroke, 2010. 41: 2932-2937 October 21, 2010.
14. Plante M, Demers L, Swaine B, Desrosiers J. Association Between Daily Activities Following Stroke Rehabilitation and Social Role Functioning Upon Return to the Community. Top Stroke Rehabil 2010. 17(1):47–57
15. Rimmer J H, Wang E, Smith D. Barriers associated with exercise and community access for individuals with stroke. Journal of Rehablitation Research & Development Volume45, Number2,2008,Page 315-322.
16. Hsueh I P , Lin J H, Jeng J S, Hsieh C L. Comparison of the psychometric characteristics of the functional independence measure, 5 item Barthel index, and 10 item Barthel index in patients with stroke. J Neurol Neurosurg Psychiatry 2002;73:188–190
17. Marcel W M, Boosman H, Zandvoort M, Passie. P, Rinkel J G, Visser M M A J. Development and validation of a short version of the stroke specific quality of life.J Neurol Neurosurg Psychiatry. 2011 Mar;82(3):283-6. Epub 2010 Aug 27.
18. Daneski K; Coshall C; Tillingand K; Wolfe C D A. Reliability and validity of a postal version of the Reintegration to Normal Living Index, modified for use with stroke patients.Clin Rehabil. 2003 Dec;17(8):835-9.
19. Mayo N E, Dauphinee S W, Robert C, Durcan L, Carlton J. Activity, Participation, and Quality of Life 6 Months Poststroke. Arch Phys Med Rehabil Vol 83, August 2002.
20. Chau P C J, Thompson D R, Twinn S, Chang A M Woo J. Determinants of participation restriction among community dwelling stroke survivors: A path analysis. BMC Neurology 2009, 9:49 doi:10.1186/1471-2377-9-49.
21. Wood P J, Connelly, Maly R. M. Getting back to real living: a qualitative study of the process of community reintegration after stroke. Clin Rehabil. 2010 Nov;24(11):1045-56. Epub 2010 Aug 16.
22. Moreland J D, Depaul G V, Dehueck L A, Pagliuso A S, Yip W C D, Pollock J B, Wilkins S. Needs assessment of individuals with stroke after discharge from hospital stratified by acute Functional Independence Measure score. Disability and Rehabilitation, 2009; 31(26): 2185–2195.
23. Chumney D, Nollinger K, Shesko K, Skop K, Spencer M, Newton R A. Ability of Functional Independence Measure to accurately predict functional outcome of stroke-specific population: Systematic review. Journal of rehabilitation Research and development Volume 47 Number 1, 2010 Pages 17-30.
24. Mackintosh S. Appraisal Clinimetrics, on FIM literature search. published it on Australian Journal of Physiotherapy 2009 Vol. 55 Australian Physiotherapy Association 2009.
25. Miller A, Clemson L, Lannin N. Measurement properties of a modified Reintegration to Normal Living Index in a community-dwelling adult rehabilitation population. Disabil Rehabil. 2011 Feb 9.
9. / SIGNATURE OF CANDIDATE
10. / REMARK OF THE GUIDE
11. / NAME AND DESIGNATION OF
11.1 GUIDE / MR.JIDESH V. V
ASSISTANT PROFESSOR
DEPT OF PHYSIOTHERAPY
11.2SIGNATURE
11.3 NAME OF THE HEAD OF THE DEPARTMENT / MR. NARASIMMAN.S
PROFESSOR
DEPARTMENT OF PHYSIOTHERAPY
11.4 SIGNATURE
12. / 12.1 REMARKS OF THE CHAIRMAN & PRINCIPAL
12.2SIGNATURE