| CTRI Number |
CTRI/2025/07/090711 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational therapy] |
| Study Design |
Other |
|
Public Title of Study
|
Empowering Stroke Survivors: The Role of Community-Based Rehab on a Budget |
|
Scientific Title of Study
|
Effectiveness of Cost Effective Community Based Occupational Therapy Interventions on Functional Independence In CVA : A Quasi Experimental Study
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raja |
| Designation |
PG student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Chettinad Academy of Research and Education deemed to be university Chettinad Health City Rajiv Gandhi Salai OMR kelambakkam tamil nadu
Chennai
TAMIL NADU
603103
India |
| Phone |
9843958502 |
| Fax |
|
| Email |
skmraja420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Debashis Rout |
| Designation |
Professor and H.O.D |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Chettinad Academy of Research and Education deemed to be university Chettinad Health City Rajiv Gandhi Salai OMR kelambakkam tamil nadu
Chennai
TAMIL NADU
603103
India |
| Phone |
9163003990 |
| Fax |
|
| Email |
debashisrout@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Raja |
| Designation |
PG student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Chettinad Academy of Research and Education deemed to be university Chettinad Health City Rajiv Gandhi Salai OMR kelambakkam tamil nadu
Chennai
TAMIL NADU
603103
India |
| Phone |
9843958502 |
| Fax |
|
| Email |
skmraja420@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital
Chettinad Academy of Research and Education deemed to be university Chettinad Health City Rajiv Gandhi Salai OMR kelambakkam tamil nadu 603103 |
|
|
Primary Sponsor
|
| Name |
Raja R |
| Address |
Chettinad Academy of Research and Education
(Deemed to be University)
Chettinad Health City
Rajiv Gandhi Salai (OMR)
Kelambakkam, TN 603103 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Raja |
Chettinad Hospital |
ward 24
Chettinad Hospital
Chettinad Academy of Research and Education
(Deemed to be University)
Chettinad Health City
Rajiv Gandhi Salai (OMR)
Kelambakkam, TN 603103
Chennai
TAMIL NADU |
9843958502
skmraja420@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy of Research and Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
community based Family mediated occupational therapy interventions |
2 months
2 session per week
45 mins per session |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult aged 20 years or more with a clinical diagnosis of stroke who met the
eligibility criteria for inclusion in the study namely At least six-month post stroke (chronic
stroke) Living at home with a carer completed intensive individual rehabilitation able to
walk independently with or without aids. • Caregivers given consent and are able adult to
provide directed programmes with no or minimum physical injury to self and the patient •
Having caregivers with sound mental condition who is able to understand the demonstrate
therapy and able to recreated |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Stroke Rehabilitation Assessment of Movement (STREAM) The Canadian Occupational
Performance Measure (COPM)
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/09/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
.This study will consist of 120 stroke patients who will be randomly assign to a single group.
Consent forms will be issued, and participants who are willing to participate will be included in
the study. Demographic data will be collected. All patients will be assessed for functional
independence using the STREM, and COPM. Participants will receive home-based occupational
therapy using family-mediated interventions. This intervention will be conducted for 45 minutes
per session, two times per week over a period of two months. All patients will be tested using
the STREM, and COPM tools before and after the intervention. The obtained values will be
tabulated and analysed statistically |