| CTRI Number |
CTRI/2025/12/099803 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving thinking and daily living skills in traumatic brain injury survivors through occupational therapy treatment |
|
Scientific Title of Study
|
Effectiveness of Occupation-Based Cognitive Retraining versus Occupation-Based metacognitive strategy training on executive function and its impact on occupational performance among traumatic brain injury survivors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Gokul A |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
Chennai
TAMIL NADU
600116
India |
| Phone |
6380000850 |
| Fax |
|
| Email |
gokulaladi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Loganathan S |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
Chennai
TAMIL NADU
600116
India |
| Phone |
9841958099 |
| Fax |
|
| Email |
loganathanot@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Loganathan S |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
Chennai
TAMIL NADU
600116
India |
| Phone |
9841958099 |
| Fax |
|
| Email |
loganathanot@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gokul. A |
| Address |
No.1 Ramachandra Nagar Porur, Chennai – 600 116
Tamil Nadu, India. |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Dr Gokul A |
Sri Ramachandra Institute of Higher Education and Research (DU) |
Ground Floor Neuro Occupational Therapy Out Patient Department Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy Sri Ramachandra Institute of Higher Education and Research Deemed to be University No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
Chennai
TAMIL NADU |
6380000850
gokulaladi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRIHER. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Occupation based cognitive retraining
|
Therapist guided structured training of executive cognitive skills including attention working memory planning problem solving cognitive flexibility inhibition initiation and task completion using repetitive task oriented cognitive practice embedded within meaningful daily occupations. Intervention is delivered once per week for twelve weeks with each session lasting one hour
|
| Comparator Agent |
Occupation based metacognitive strategy training
|
Participant driven metacognitive strategy training emphasizing self awareness goal setting planning self monitoring self regulation strategy generation error identification and performance self evaluation using the goal plan do check approach embedded within meaningful daily occupations without direct therapist led repetitive cognitive drills. Training is delivered once per week for twelve weeks with each session lasting one hour
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participant with at least one year and not more than 5 years of Post Traumatic Brain Injury will be included.
2. Age between 18 – 60 years will be included.
3. Mild to moderate cognitive impairment by a score ranging between 10 and 25 on the Montreal Cognitive Assessment (MoCA) will be included.
4. A deficient score greater than 78 seconds in Trail Making Test (TMT-B&W) – A and a deficient score greater than 273 seconds in Trail Making Test (TMT-B&W) – B.
5. The participant should be able to understand and write either English or Tamil. |
|
| ExclusionCriteria |
| Details |
1. Participants with any other significant medical, neurological, psychiatric and orthopedic conditions will be excluded.
2. Severe physical impairments that would prevent active participation in community-based or occupation-based interventions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Occupation-Based Cognitive Retraining versus Occupation-Based Metacognitive Strategy Training on Executive Functions. Measured by Executive function measured using the Executive Skills Questionnaire – Revised (ESQ-R). |
Baseline (Pre-intervention) and after 12 weeks of intervention (Post-intervention). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze its impact on Occupational performance and Instrumental Activities of Daily Living. Occupational performance measured using the Canadian Occupational Performance Measure (COPM) and Instrumental activities of daily living measured using UK-FIM FAM (Extended ADL components). |
Baseline (Pre-intervention) and after 12 weeks of intervention (Post-intervention). |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2026 |
| Date of Study Completion (India) |
15/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
This study aims to compare the effectiveness of occupation based cognitive retraining and occupation based metacognitive strategy training on executive function occupational performance and instrumental activities of daily living among individuals with traumatic brain injury. The study is a randomized controlled trial conducted at Sri Ramachandra Hospital Chennai. A total of thirty participants aged between eighteen and sixty years with traumatic brain injury of one to five years duration will be recruited and randomly allocated into two intervention groups. Group A will receive occupation based cognitive retraining and Group B will receive occupation based metacognitive strategy training. The intervention will be provided for twelve weeks with one session per week. Executive function occupational performance and instrumental activities of daily living will be assessed before and after the intervention using standardized outcome measures. The findings of this study are expected to provide evidence on the effectiveness of occupation based interventions in improving executive function occupational performance and instrumental activities of daily living among traumatic brain injury survivors. |