| CTRI Number |
CTRI/2018/08/015212 [Registered on: 07/08/2018] Trial Registered Prospectively |
| Last Modified On: |
28/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Adherence to home-based exercises among stroke survivors |
|
Scientific Title of Study
|
Development and testing of adherence-enhancing strategies for home-based physical exercise program in community-dwelling stroke survivors. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amreen Mahmood |
| Designation |
PhD scholar |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
09873939367 |
| Fax |
|
| Email |
mail4amreen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr John Solomon M |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy, SOAHS, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670671 |
| Fax |
|
| Email |
john.solomon@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manikandan Natarajan |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy, SOAHS, Manipal University, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TMA pai Scholarship |
| Address |
Manipal University, Manipal, Udupi, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amreen Mahmood |
Kasturba Hospital |
Medicine wards in Kasturba Hospital, Manipal Academy of Higher Education, Manipal, 576104
Udupi
KARNATAKA |
9873939367
mail4amreen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee: Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Standard rehabilitation exercises will be provided based on ASA recommendations and routine home-based exercises will be provided to the participants without any adherence-enhancing strategies. |
| Intervention |
Experimental Group |
Standard rehabilitation exercises, based on the ASA recommendations, will be provided to the participants along with adherence-enhancing strategies (AES) to carry out home-based exercises. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient having motor impairment resulting from stroke
Medically stable
Referred for physiotherapy
Had undergone at least one exercise session
Functional communication abilities
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of adherence in percentage |
Baseline, 6 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mobility Disability Scale score |
Baseline, 6 weeks and 12 weeks |
| Goal Attainment Scale Score |
Baseline, 6 weeks and 12 weeks |
| Stroke impact scale score |
Baseline, 6 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2018 |
| Date of Study Completion (India) |
31/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Stroke leads to disabilities that need to be managed in the long-term. Regular exercises are of paramount importance for improving function and health-related quality of life. For long-term continuance of exercises, home-based interventions are most suitable for chronic conditions. However, home-based exercises are often unsupervised therefore self-management, and compliance with the treatment regimen is difficult.
Adherence among stroke survivors is found to be less than ideal. Recommendations are for strategies to instill a long-term commitment to a physically active lifestyle, that should be initiated during formal stroke rehabilitation, but evidence to guide intervention is lacking. Hence, there is a need to develop strategies to improve adherence to home-based exercises in stroke survivors to facilitate recovery and optimize functions after a stroke.
The objective of this RCT is to determine the effectiveness of Adherence-Enhancing Strategies on the level of adherence, mobility, and quality of life in stroke survivors.
|