| CTRI Number |
CTRI/2025/12/098903 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Benefits of game-based hand exercises in patients with head injury |
|
Scientific Title of Study
|
Effect of gamified hand training on individuals with mild to moderate 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 |
N SATTYA |
| Designation |
Master of Physiotherapy (AdvancedPT 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 |
6379497102 |
| Fax |
|
| Email |
sattyananthagopal01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKARTHIK BABU |
| 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 |
| 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 |
| Sattya N |
Kovai Medical Center Hospital |
Department of Physiotherapy and Rehabilitation,
Ground floor, Avinasi road, Coimbatore.
Coimbatore
TAMIL NADU |
6379497102
sattyananthagopal01@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: V029||Pedestrian injured in collision with two- or three-wheeled motor vehicle, unspecified whether traffic or nontraffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional hand therapy |
conventional hand therapy helps to engage the patients with task oriented exercises |
| Intervention |
Squegg gamified hand traing |
squegg gamified hand training helps the individuals to engage in the treatment and helps with neuroplasity |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. GCS level mild ( 13-15 ) to moderate ( 9-12 )
2. MOCA greater or equal to 26 score
3. RLA Scale above level 6 |
|
| ExclusionCriteria |
| Details |
1. Upper limb fracture.
2. Individuals with a pre-existing chronic illness or neurological or psychiatric condition.
3. Individuals with pre-existing cardiovascular conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Squegg digital hand dynamometer.
|
Baseline & 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nine hole peg test
Barthel index |
Baseline & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/12/2025 |
| 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)
|
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
|
The study examines methods to improve hand grip in individuals with mild to moderate traumatic brain injury (TBI). Hand impairment can lead to muscle tightness and weakness, as well as difficulty holding objects during daily activities. This research aims to enhance hand grip through gamified hand training using different types of games, which promote precise movement and help individuals adapt to daily tasks that may be challenging after TBI. Outcome measures are the Squeeze Digital Hand Dynamometer, the Nine-Hole Peg Test and the Barthel Index, which will be taken as an initial assessment and after a 4-week follow-up assessment. |