FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072380 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 10/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   mixed method 
Study Design  Other 
Public Title of Study   Adherence to Home Exercise After Stroke Survivors. 
Scientific Title of Study   Adherence to Home Exercise Program in Stroke Survivors: A Mixed Method 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavya y 
Designation  post graduate student 
Affiliation  SDM College of Physiotherapy 
Address  OPD NO.05 Neurophysiotherapy Department shri dharmasthala manjunatheswara college of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  8880253443  
Fax    
Email  kavyasgp14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kavya y 
Designation  post graduate student 
Affiliation  SDM College of Physiotherapy 
Address  OPD NO.05 Neurophysiotherapy Department shri dharmasthala manjunatheswara college of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  8880253443  
Fax    
Email  kavyasgp14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharmila D 
Designation  Professor and PG Guide 
Affiliation  SDM College of Physiotherapy 
Address  OPD NO.05 Neurophysiotherapy Department shri dharmasthala manjunatheswara college of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.

Dharwad
KARNATAKA
580009
India 
Phone  9880950990  
Fax    
Email  sharmila.dudhani@sdmuniversity.edu.in  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara College Of Physiotherapy, Manjushree nagar sattur, dharwad, karnataka, India 580009 
 
Primary Sponsor  
Name  kavya y 
Address  Shri Dharmasthala Manjunatheshwara College Of Physiotherapy, Manjushree nagar sattur, dharwad.  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
kavya y  Shri Dharmasthala Manjunatheshwara College Of Physiotherapy  OPD NO. 05 Neurophysiotherapy Department.
Dharwad
KARNATAKA 		 8880253443

kavyasgp14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICE-SDM College of Medical Science & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Stroke patients who have been advised for home exercise program by physiotherapist
2 Patients with poststroke duration more than 6 months
 
 
ExclusionCriteria 
Details  •Stroke patients with aphasia
•Stroke patients with cognitive impairment
•Stroke patient who are bed ridden and dependent for all the exercises on a caregiver
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Stroke-Specific Measure of Adherence to Home Based Exercise (SS-MAHE)
National institutes of health stroke scale (NIHSS)
semi structured personal interview  		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
No Secondary Outcome  NIL 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Stroke (cerebrovascular accident [CVA]) is the sudden loss of neurological function caused by an interruption of blood flow to the brain . According to WHO stroke is defined as ‘rapidly developed clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than of vascular origin.
Post discharge, Home Exercise Program (HEP) is an integral part of patient care so as to maintain and progress functional recovery . In order to gain the benefits of HEP, adherence to the exercises prescribed by the therapist becomes indispensable and frequently studies have reported how a high level of adherence is important for HEP . The level of adherence to prescribed home exercise program in India is only about 28%.  Improved outcomes reported following high dosage of therapy (additional physical therapy time and exercises), has been questioned due to lack of resources and lower tolerance by the stroke survivors. 
SS-MAHE is the only measure specifically designed to evaluate adherence to HEP and this scale determines adherence in terms of percentage, however as a therapist it is important to know why the stroke survivors are non-adherent to HEP. There are various factors that could lead to non-adherence for instance lack of motivation, lack of support from care giver, environmental factors,  fatigue, depression, lack of confidence, severity of disease is leading to a low score on the scale.

Though SS-MAHE can help to quantify the adherence to HEP, but the patient’s perspective becomes equally important to understand why the Patient is or not adherent to HEP. Through qualitative enquiry can help  researchers to understand what could be the factors influencing adherence to HEP.

Objective measures to evaluate adherence to home exercise program are lacking. Previously studies have used log books, diaries, accelerometers and app-based devices to quantify adherence, however adherence can be quantified in terms of frequency, duration and intensity of exercise. the Stroke Specific Measure of Adherence to Home based Exercise is one such questionnaire which has all the aspects. Relying only on questionnaire without considering the patients perspective may not provide a comprehensive understanding of the various factors that could impact their commitment to HEP. Therefore, the study’s novelty lies in analysing data through a mixed-method approach, combining quantitative and qualitative analyses for a more holistic view of stroke survivors’ perspectives.

 
 
Close