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CTRI Number  CTRI/2025/08/093934 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 29/01/2026
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   A study to find out if game based training helps stroke patients recover arm strength and thinking skills.” 
Scientific Title of Study   Effectiveness of an intensive, functional gamified rehabilitation in improving sensory-motor and cognitive function following chronic stroke: A multicenter randomized clinical trial 
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 Manipal Academy of Higher Education Manipal Udupi
Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi
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 Manipal Academy of Higher Education Manipal Udupi
Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi
Udupi
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 Manipal Academy of Higher Education Manipal Udupi
Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi
Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Source of Monetary or Material Support  
ICMR FUNDED PROJECT 
 
Primary Sponsor  
Name  Indian Council for Medical Research (ICMR) 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Senthil Kumaran D  Kasturba Hospital Manipal  Department of Physiotherapy, Kasturba Hospital, Manipal, Karnataka
Udupi
KARNATAKA 		 9986910303

senthil.kumaran@manipal.edu 
Dr Senthil Kumaran D  Poovanthi Institute of Rehabilitation  Poovanthi Institute of Rehabilitation and Elder Care, Madurai, Tamil Nadu
Madurai
TAMIL NADU 		 9986910303

senthil.kumaran@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
KMC Mangalore IEC  Approved 
Poovanthi Institute of Rehabilitation and Elder care  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I60-I69||Cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intensive,functional, gamified rehabilitation program   The experimental group (EG) will receive intensive, functional, gamified rehabilitation using the ArmAble™ device under the supervision of a therapist. The ArmAble™ is a portable “Plug Play” device consisting of a computer monitor, gaming software, and a platform with a game console. The game console allows the participants to move their arms in the anteroposterior and/or mediolateral directions while playing interactive functional games.There is an option of attaching various types of handles to the gaming console based on the requirements of each game. There are two sorts of therapy games: functional games which incorporate activities of daily living tasks that are culturally relevant, context-specific, and meaningful to the participants, and non-functional games which are fun-based. In both of them, reaching and grasping movements are encouraged, which necessitate simultaneous flexion/extension, abduction/adduction of the shoulder, flexion/extension of the elbow and flexion/extension, and radial/ulnar deviation of the wrist. The participants in the EG were provided with both functional games (for example, delicious dosa, strike the mosquito, champion cleaner, and so on) and fun-based/commercial games (for example, bouncing the ball, Table tennis, fresh fruit catcher, and so on). The intervention for 45-60 minutes per day, six days per week for two weeks under the supervision of a qualified therapist. Conventional therapy consisted of facilitatory/inhibitory techniques, strength training, passive and active limb mobilization, balance, and ambulatory training for at least 45-60 minutes/day. Following the two-week intervention phase, participants will receive a functional rehabilitation program at the participants home for four weeks, lasting 30 minutes per day, six days per week. The purpose of this home training is to maintain and retain the effects of game-based rehabilitation therefore, no active game-based training will be received by the EG during this period. 
Comparator Agent  Task- Oriented training  Participants allotted to the comparator group (CG) will receive intensive, repetitive, task-oriented movements of the affected UL that cover everyday functional activities such as lifting the UL and placing it on the table, pulling a chair with one hand, opening the fingers to grip a cup, and navigating it towards the mouth. Each participant will complete three minimum tasks at least for 100 times every session (for a total of 300 repetitions per session). CG will receive the intervention for 45-60 minutes per day, six days per week for two weeks under the supervision of a qualified therapist. Conventional therapy consisted of facilitatory/inhibitory techniques, strength training, passive and active limb mobilization, balance, and ambulatory training for at least 45-60 minutes/day. Following the two-week intervention phase, participants will receive a functional rehabilitation program at the participants home for four weeks, lasting 30 minutes per day, six days per week. There will not be any difference in the content or amount of training done at home between the EG and CG. The purpose of this home training is to maintain and retain the effects of game-based rehabilitation therefore, no active game-based training will be received by the EG during this period. During this follow-up period, all participants will be given a logbook to keep track of their therapy sessions at home. A weekly phone call will be made to participants to make sure they are following the therapy program at home. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Clinically and or radiologically confirmed unilateral chronic stroke (more than 6 months post-stroke) diagnosed by a physician

Age between 18 and 80 years

Male or female participants.

Hemodynamically stable.

Stroke severity score more than 6 on the National Institutes of Health Stroke Scale

Brunnstrom voluntary control grade between 1 and 5 in the affected upper limb

Modified Ashworth Scale score less than or equal to 3 in the affected upper limb

Ability to sit independently or with support 
 
ExclusionCriteria 
Details  Global or receptive aphasia

Major medical problems or co-morbidities that preclude participation, such as shoulder pain in the paretic limb, shoulder subluxation/dislocation, severe arthritis, or prior surgery resulting in functional limitation.

Complex regional pain syndrome

Functional vision or hearing impairments that limit computer use

Vestibular disorders 
 
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 
The Fugl-Meyer Assessment-upper extremity (FMA) (40),
The Action Research Arm Test (ARAT) Scale (41)
Nottingham sensory assessment (25)
Montreal Cognitive Assessment Scale (MoCA) (28) 		 Pre-intervention (T0)
Post-intervention at 2 weeks (T1)
Follow up assessment at 6 weeks (T2)
 
 
Secondary Outcome  
Outcome  TimePoints 
The Motricity Index (MI) scale- arm component (32),
The modified Rankin Scale (mRS) (42),
The Stroke Impact Scale (SIS) version 3.0, (43)
 		 Pre-intervention (T0)
Post-intervention at 2 weeks (T1)
Follow up assessment at 6 weeks (T2)
 
The Game User Experience satisfaction scale (GUESS)  Post-intervention at 2 weeks only 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3 
Date of First Enrollment (India)   09/09/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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   Stroke is a major disabling disease which affects both upper and lower limbs resulting in a wide range of impairments, activity limitations and participation restrictions. However, upper limb impairments recover slowly and the amount of recovery is less compared to the lower limb. Studies have established that an intensive, repetitive, and task specific exercise program improves upper limb function in patients with stroke even after six months. ArmAble™ which is an interactive arm rehabilitation device has been developed recently which incorporates the principles of motor learning and neuroplasticity. Therapy using ArmAble™ caters intensive, repetitive training and it is fun based, motivating, challenging and provides feedback. No studies exist on investigating the effect of low-cost gaming rehabilitation using ArmAble™ which is commercially available, functionally relevant and on the chronic stages of stroke. Therefore, the aim of this study is to determine the effectiveness of an intensive, functional, gamified rehabilitation program compared to a conventional therapy program on upper limb sensorimotor and cognitive function in people with chronic stroke. 
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