| CTRI Number |
CTRI/2025/07/090697 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Helping Stroke Survivors Improve Confidence and Everyday Skills Through a CO-OP Therapy Program |
|
Scientific Title of Study
|
Effectiveness of Cognitive Orientation to daily Occupational Performance (CO-OP) approach in enhancing occupational performance and
self-efficacy with an emphasis on untrained tasks for patients with Stroke
|
| Trial Acronym |
COOP-CVA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jacob Sharon Nathan J |
| Designation |
MOT - 2nd Year student |
| Affiliation |
KMCH College of Occupational Therapy |
| Address |
SF No 259 and 267
Kalapatti post
Coimbatore 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
8870275264 |
| Fax |
|
| Email |
jacobsharonnathanj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C Yamuna |
| Designation |
Professor |
| Affiliation |
KMCH College of Occupational Therapy |
| Address |
SF No 259 and 267
Kalapatti post
Coimbatore 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9677610885 |
| Fax |
|
| Email |
yamunachandran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
C Yamuna |
| Designation |
Professor |
| Affiliation |
KMCH College of Occupational Therapy |
| Address |
SF No 259 and 267
Kalapatti post
Coimbatore 641048
TAMIL NADU
641048
India |
| Phone |
9677610885 |
| Fax |
|
| Email |
yamunachandran@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mrs Yamuna C |
| Address |
SF No 259 and 267
Kalapatti post
Coimbatore 641048 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jacob Sharon Nathan J |
Kovai Medical Center and Hospital |
Dr.Sujatha Missal, HOD of Occupational therapy, Kovai Medical Center and Hospital, Avanashi Road, Coimbatore, Tamilnadu
Coimbatore
TAMIL NADU |
04224323731
sujatamissal@kmchhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE KMCH INSTITUTE OF ALLIED HEALTH SCIENCES |
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 |
Cognitive Orientation to daily Occupational Performance (CO-OP) approach |
Cognitive Orientation to daily Occupational Performance (CO-OP) is a complex treatment approach that differs from other contemporary stroke rehabilitation approaches in that it combines theory and evidence from both motor and cognitive sciences and situates them in an educational, client-centered framework. It is defined as “a client-centered, performance-based, problem solving approach that enables skill acquisition through a process of strategy use and guided discovery.” The clinical objectives are skill acquisition, cognitive strategy use, and generalization and transfer of learning. |
| Comparator Agent |
Standard Occupational Therapy Intervention (combination of traditional and contemporary intervention techniques) |
The control group in the study will receive a combination of traditional and contemporary intervention techniques, including the Biomechanical Frame of Reference, Proprioceptive Neuromuscular Facilitation (PNF), Neurodevelopmental Therapy (NDT), Task-Oriented Approach, Motor Relearning Approach, Occupational Adaptation, and Rehabilitative Approaches. These techniques were employed to enhance both occupational performance and self-efficacy. Overall, the goal of these approaches was to promote functional independence in individuals recovering from a stroke. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed stroke.
2. Patients those who are willing to participate in the study.
3. Patients experiencing difficulties in occupational performance.
4. Patients aged 18 years and above.
5. Both Male and female genders.
6. Patients with a MoCA score Greater than 18.
7. Patients with an NIH Stroke Scale score Less than 14. |
|
| ExclusionCriteria |
| Details |
1. Patients with moderate to severe aphasia or dysarthria.
2. Patients with unstable medical conditions
3. Patient with severe visual and hearing impairments.
4. Patient with Major psychiatric illness (e.g., Severe depression, psychosis). |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occupational Performance and Self-efficacy |
Occupational Performance and Self-efficacy scores at pretest, post test on 4th week, follow-up test on 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Transfer of skills to untrained tasks. |
Occupational Performance and Self-efficacy scores at pretest, post test on 4th week, follow-up test on 6th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
11/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/10/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
- Evaluating the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach in improving occupational performance and self-efficacy, particularly in facilitating the transfer of skills to untrained tasks, within the Indian stroke population is crucial. Research suggests that self-efficacy plays a vital role in facilitating the transfer of skills from easier to more challenging tasks, potentially serving as a stronger mediator than implicit learning.
- However, existing evidence remains inconclusive, and further investigation is required to validate these findings. Understanding the precise influence of self-efficacy on skill transfer is essential for optimizing stroke rehabilitation strategies.
- Given the unique demographic and healthcare context of the Indian stroke population, it is necessary to explore the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach in enhancing occupational performance and self-efficacy, with a particular focus on its impact on untrained tasks.
- Hence, there is a need to bridge this gap by evaluating effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach in improving occupational performance and self-efficacy, particularly in transferring skills to untrained tasks.
- This study aim to evaluate the effectiveness of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach in improving occupational performance and self-efficacy among the stroke patients, emphasize on the transfer of skills to untrained tasks.
|