| CTRI Number |
CTRI/2025/12/098473 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Home exercises for balance and daily activities in head injury |
|
Scientific Title of Study
|
Family-led home exercise program on balance and daily activities in individuals with traumatic brain injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUBATHRA A |
| Designation |
Masters of Physiotherapy (Advanced PT in Neurology) |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
KMCH College of Physiotherapy
SF NO: 256 &267,Kalapatti Post, Coimbatore-641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
7094924380 |
| Fax |
|
| Email |
subathraarasan2201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KARTHIK BABU S PT PhD |
| Designation |
Principal & Professor |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
KMCH College of Physiotherapy
SF.NO. 256 &267, Kalapatti Post, Coimbatore-641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KARTHIK BABU S PT PhD |
| Designation |
Principal & Professor |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
KMCH College of Physiotherapy
SF.No. 256 &267, Kalapatti Post, Coimbatore-641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMCH College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
KMCH College of Physiotherapy |
| Address |
SF NO:259 & 267 Kalapatti Post, Coimbatore - 641048 |
| 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 |
| Subathra A |
Kovai Medical Center Hospital |
Department of Physiotherapy and Rehabilitation
Ground floor,
Avinasi Road, Coimbatore
Coimbatore
TAMIL NADU |
7094924380
subathraarasan2201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL 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: G939||Disorder of brain, unspecified, (2) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family led Home Exercise program |
Individuals will be discharged home and begin a caregiver-supervised exercise program including sitting, standing, and walking balance activities tailored to their abilities. Caregivers will facilitate 45–60 minute sessions, five days per week, while therapists provide remote support and progression advice. Feasibility will be tracked with check-in forms, and adherence ensured through geo-tagged photos/videos, daily calls, and caregiver checklists. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.GCS 9-15
2.Ability to perform sit to stand independently
3.Able to follow simple commands
4.Able to communicate in the language used in the rehabilitation program(English or Tamil) |
|
| ExclusionCriteria |
| Details |
1.Individuals with other medical injuries that may affect sitting and standing
2.Individuals with previous diagnosis of other neurological conditions
3.Individuals with major polytrauma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Five time-sit-to-stand test
2. Modified Clinical Test of Sensory Interaction on Balance
3. Barthel index |
1. At the time of discharge
2. one months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Barthel index |
1. At the time of discharge
2. one months follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/12/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study involves individuals with mild to moderate TBI undergoing a family-led home-based exercise program to improve balance and daily activities, supervised by caregivers. Outcomes (FTSST, mCTSIB, Barthel Index) will be assessed at discharge and follow-up, with feasibility and adherence monitored through check-ins, caregiver checklists, and remote tracking. |