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CTRI Number  CTRI/2025/04/084323 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Can game therapy at home improve hand activity after stroke 
Scientific Title of Study   Effect of a Home-based Gamified, Intensive, and Functional Tele-rehabilitation (Home-GIFT) program on improving upper limb function following stroke 
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 Senthil Kumaran D 
Designation  Additional Professor 
Affiliation  Manipal college of health professions 
Address  Department of Physiotherapy, Manipal college Of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Senthil Kumaran D 
Designation  Additional Professor 
Affiliation  Manipal college of health professions 
Address  Department of Physiotherapy, Manipal college Of Health Professions, MAHE, Manipal


KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Senthil Kumaran D 
Designation  Additional Professor 
Affiliation  Manipal college of health professions 
Address  Department of Physiotherapy, Manipal college Of Health Professions, MAHE, Manipal


KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Source of Monetary or Material Support  
Medical Instruments Devices Allied Services Department of Science and Technology Hub Ground floor Manipal Central Research Instrumentation Facility MIT camous Mnipal Academy of Higher education Manipal Karnataka India Pin code 576104 
 
Primary Sponsor  
Name  Medical Instruments Devices Allied Services Department of Science and Technology Hub 
Address  Medical Instruments Devices Allied Services Department of Science and Technology Hub Ground floor Manipal Central Research Instrumentation Facility MIT camous Mnipal Academy of Higher education Manipal Karnataka India Pin code 576104 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Senthil Kumaran D  Kasturba Hospital Manipal  Department of Physiotherapy Room No: 102, N-Block, 1st Floor Baliga Block, Kasturba Hospital Madhav Nagar, Manipal – 576104 Karnataka, India
Udupi
KARNATAKA 		 9986910303

senthil.kumaran@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G461||Anterior cerebral artery syndrome, (2) ICD-10 Condition: G460||Middle cerebral artery syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Home- based Gamified,intensive,functional tele-rehabilitation(Home-GIFT) + Additional convential therapy followed by home-based, functional rehabilitation program  Dose: Home-GIFT 45 min-1 hour per day; Duration: 6 days per week for 4 weeks for conventional therapy: 1 hour/day,6 days/week,for 4 weeks home based functional rehabilitation 30 min/day, 6 days a week for 4 weeks 
Comparator Agent  Task-based training + conventional therapy followed by home-based, function al rehabilitation program  Dose: Task-based Training 45-1 hour per day;Duration:6 days per week for 4 weeks for conventional therapy: 1 hour per day, 6 days per week for 4 weeks home based functional rehabilitation 30 min/day,6 days a week for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnosed with acute or sub-acute unilateral stroke
Hemodynamically stable participants having a stroke severity score more than 6 on the National Institute of Health Stroke Scale (NIHSS)
A Chedoke-McMaster arm component score 2-6 in the affected upper limb
The ability to sit with or without support and living in the community
 
 
ExclusionCriteria 
Details  Patients with unstable medical conditions/disease
Uncooperative patients
Patients with upper extremity musculoskeletal conditions/disease that preclude assessment and intervention (for e.g., Severe shoulder pain)
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Fugl-Meyer Assessment- Upper extremity
Action research arm test

 		 baseline, 4th week and 8th week

 
 
Secondary Outcome  
Outcome  TimePoints 
Motricity index score
Kinematic measures of upper extremity reach
Visual analog fatigue scale
mRS
SIS (version 3.0)
Distance covered with upper extremity using ArmAble mini device (Home-GIFT)
 		 baseline, 4th week and 8th week 
 
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   Phase 2 
Date of First Enrollment (India)   15/04/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

All stroke patients in the neurology ward and the OPD of Kasturba Hospital will be screened. Informed consent will be obtained from patients willing to participate. Baseline assessment will be conducted (Demographics, ARAT, Fugl Meyer Assessment UE, Motricity index, mRS, SIS 3.0, visual fatigue scale, kinematic measures of upper extremity reach). For the experimental group, home-based gamified, intensive, functional telerehabilitation (Home-GIFT using ArmAble Mini device) will be provided for approximately 45 mins to 1 hour per day. The therapy will be delivered at home, with the telemonitoring to track progress and ensure adherence, while the control group will follow a task-oriented program for about 45 min to 1 hour per day. Both groups should perform their exercises at home for 6 days per week for 4 weeks. Additionally, both groups will receive conventional therapy for 1 hour/day, 6 days/week for 4 weeks, followed by a home-based, functional rehabilitation program for another 4 weeks (~30 min/day, 6 days/week). This will be followed by a home-based functional exercise program (30 min/day, 6 days a week for 4 weeks). All outcome measures will be measured at baseline, 4-week post-intervention, and at the Completion of the follow-up assessment at the 8th week. Data obtained will be analysed using R Studio software.

 
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