CTRI/2025/01/079679 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On:
25/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Physiotherapy (Not Including YOGA)
Study Design
Randomized, Parallel Group Trial
Public Title of Study
How game-based therapy can help stroke patients become more active
Scientific Title of Study
Effectiveness of A Game Based Rehabilitation on Sedentary Behavior and Physical Activity in Patients with Acute and Subacute Stroke A Multicenter Randomized Clinical Trial
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
S Aparna Selvam
Designation
PhD Scholar
Affiliation
Manipal college of Health Professions, Manipal Academy of Higher education, Manipal
Address
Kasturba Hospital
Department of Physiotherapy
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 Department of Physiotherapy
Manipal college of Health Professions, Manipal Academy of Higher education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 Udupi KARNATAKA 576104 India
Phone
7349403537
Fax
Email
aparna.mchpmpl2023@learner.manipal.edu
Details of Contact Person Scientific Query
Name
Dr Senthil Kumaran D
Designation
Additional Professor
Affiliation
Manipal college of Health Professions, Manipal Academy of Higher education, Manipal
Address
Kasturba Hospital
Department of Physiotherapy
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 Department of Physiotherapy
Manipal college of Health Professions, Manipal Academy of Higher education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 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, Manipal Academy of Higher education, Manipal
Address
Kasturba Hospital
Department of Physiotherapy
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 Department of Physiotherapy
Manipal college of Health Professions, Manipal Academy of Higher education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 Udupi KARNATAKA 576104 India
Phone
9986910303
Fax
Email
senthil.kumaran@manipal.edu
Source of Monetary or Material Support
Be Able Health Pvt Ltd Centre for Healthcare Entrepreneurship, IIT Hyderabad, Kandi, Sangareddy, Telangana India 502285
Manipal Academy of Higher Education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka India 576104
Primary Sponsor
Name
Manipal Academy of Higher Education
Address
Manipal Academy of Higher Education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka India 576104
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
Be Able Health Pvt Ltd
Be Able Health Pvt Ltd
Centre for Healthcare Entrepreneurship,
IIT Hyderabad, Kandi,
Sangareddy, Telangana 502285
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
S Aparna Selvam
Kasturba Hospital, Manipal
Department of Neurology and Department of Physiotherapy-Neurorehabilitation unit
Kasturba Hospital,
Udupi - Hebri Rd, Madhav Nagar, Manipal,
Karnataka India 576104
Udupi KARNATAKA
7349403537
aparna.mchpmpl2023@learner.manipal.edu
S Punitha
Poovanthi Institute of Rehabilitation And Elder Care
Department of Physiotherapy, Poovanthi Institute of Rehabilitation And Elder Care Melur Main Rd, Puvandi, Sivaganga Tamil Nadu India 630611 Sivaganga TAMIL NADU
Aravind Medical Research Foundation ethics committee
Approved
Kasturba Medical College/Kasturba Hospital Institutional Ethical Committee (KMC/KH IEC)
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
conventional therapy and Home based context specific exercise training and
Conventional therapy program
Rationale:Neuroplasticity, motor learning, functional recovery, prevention of secondary complications, individualized care, cardiovascular fitness enhancement, and psychosocial well-being
Procedures/Materials: Conventional therapy includes patient and caregiver education, passive and active mobilization of limbs, facilitatory/inhibitory techniques, muscle strengthening, balance and gait training, and aerobic and resistance exercises.
Delivery and mode:Individual therapy sessions,Supervised therapy sessions
How much:: 45-60 min/day per session, 2 sessions per day, 6 days/ week for 3 weeks
Tailoring:The intervention will be decided based on assessment, patient goals and will be modified based on the patient’s progress
Home Based Context-specific exercise program
Rationale:Functional task training, task-oriented training, generalization of skills, individualized treatment plans, cognitive and motor integration, promotion of independence, family involvement, increased motivation, environmental adaptation and long-term sustainability
Procedures/Materials:Participants in the experimental group will receive context-specific exercise which is based on aerobic activities, strengthening activities and balance activities as per the patient’s ability and goals
Delivery and mode:Home based program as advised by the therapist
Patients by themselves under the supervision of caregivers
How much:10-15 mins/day , 6 days/wk , for 1 month (3 of the selected activites from each domain ) with weekly reminder from the therapist over phone call or text messages
Tailoring:The intervention will be decided based on assessment, patients’ goals and will be modified based on the patient’s ability and progress
Intervention
Game based rehablitation using ArmAble and conventional therapy and Home based context specific exercise training and
Game-based rehabilitation-ArmAble
Rationale: Neuroplasticity, enhancing motivation, focusing on task-specific training, biofeedback Procedures/
Materials: Participants in the experimental group will receive patient and caregiver education, and gamified rehabilitation using ArmAbleâ„¢ under the supervision of the therapist
Delivery and mode: Individual therapy sessions, Supervised therapy session
How much:45-60 min/day per session, one session per day, 6 days/ week for 3 weeks
Tailoring: The intervention will be decided based on the assessment patients goals and will be modified based on the patient’s ability and progress
Progression: Patients will be made to play UE and LE games with ArmAble™ in sitting, semi-sitting and standing positions based on the patients’ ability , feedback, adaptive challenges, motor learning, cognitive integration, and social interaction
Conventional therapy program
Rationale:Neuroplasticity, motor learning, functional recovery, prevention of secondary complications, individualized care, cardiovascular fitness enhancement, and psychosocial well-being
Procedures/Materials: Conventional therapy includes patient and caregiver education, passive and active mobilization of limbs, facilitatory/inhibitory techniques, muscle strengthening, balance and gait training, and aerobic and resistance exercises.
Delivery and mode:Individual therapy sessions,Supervised therapy sessions
How much:: 45-60 min/day per session, 2 sessions per day, 6 days/ week for 3 weeks
Tailoring:The intervention will be decided based on assessment, patient goals and will be modified based on the patient’s progress
Home Based Context-specific exercise program
Rationale:Functional task training, task-oriented training, generalization of skills, individualized treatment plans, cognitive and motor integration, promotion of independence, family involvement, increased motivation, environmental adaptation and long-term sustainability
Procedures/Materials:Participants in the experimental group will receive context-specific exercise which is based on aerobic activities, strengthening activities and balance activities as per the patient’s ability and goals
Delivery and mode:Home based program as advised by the therapist
Patients by themselves under the supervision of caregivers
How much:10-15 mins/day , 6 days/wk , for 1 month (3 of the selected activites from each domain ) with weekly reminder from the therapist over phone call or text messages
Tailoring:The intervention will be decided based on assessment, patients’ goals and will be modified based on the patient’s ability and progress
The presence of the first ischemic or hemorrhagic stroke has been clinically and radiologically confirmed by a physician.
Aged eighteen years and above
Medically stable (with systolic blood pressure: one hundred twenty to one hundred sixty millimeters of mercury
Oxygen saturation: greater than ninety-two percent
Heart rate: forty to one hundred beats per minute
Temperature: less than thirty-eight point five degrees Celsius)
Montreal Cognitive Assessment score greater than or equal to twenty-six points
Stroke severity score greater than five and less than twenty-four on the NIH Stroke Scale (NIHSS)
PHASE TWO
The presence of the first ischemic or hemorrhagic stroke has been clinically and radiologically confirmed by a physician.
Aged eighteen years and above
Medically stable (with systolic blood pressure: one hundred twenty to one hundred sixty millimeters of mercury
Oxygen saturation: greater than ninety-two percent
Heart rate: forty to one hundred beats per minute
Temperature: less than thirty-eight point five degrees Celsius)
Patients with premorbid disability with a modified Rankin Scale score less than four
Stroke severity score greater than five and less than twenty-four on the NIH Stroke Scale (NIHSS)
The Brunnstrom voluntary control grade greater than or equal to one and less than or equal to six in the affected limb
Modified Ashworth Scale score less than or equal to three in the affected limb
Montreal Cognitive Assessment score greater than or equal to twenty-six points
Ability to come to a propped-up position with or without support
ExclusionCriteria
Details
PHASE 1
Global or receptive aphasia
Severe infections and cardiopulmonary diseases
Any brain-related surgical procedure
Any skin problems in the area of accelerometer placement.
Any other musculoskeletal conditions or significant medical problems or co-morbidities
Early deterioration/Premature decline
Isolation regime because of infection
Physician-ordered bed rest
PHASE 2
Global or receptive aphasia
Severe infections and cardiopulmonary diseases (acute coronary syndrome, severe heart failure)
Any brain-related surgical procedure
Any skin problems in the area of accelerometer placement.
Early deterioration/Premature decline
Any other musculoskeletal conditions or significant medical problems or co-morbidities
Isolation regime because of infection
Physician-ordered bed rest
Continuous monitoring will be performed from the time of recruitment until hospital discharge or up to 7 days, whichever occurs first.
Phase 2
Continuous monitoring will be conducted for 3 consecutive days post-recruitment and repeated for an additional 3 consecutive days at the end of the 3-week intervention period.
The National Institutes of Health Stroke Scale (NIHSS)
Phase 1
Assessments will be conducted at the time of recruitment & at hospital discharge, or on the 7th day post-recruitment, whichever occurs first.
Phase 2
Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period.
Montreal Cognitive Assessment (MoCA)
Phase 1
Assessments will be conducted at the time of recruitment & at hospital discharge or on the 7th day post-recruitment, whichever occurs first. A follow-up assessment will be performed 1 month after this time point, via a telephonic interview.
Phase 2
Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period. A follow-up assessment will be performed 1 month after completion of the 3-week intervention, via a telephonic interview.
Fugl-Meyer Assessment (FMA)
Phase 1
Assessments will be conducted at the time of recruitment & at hospital discharge, or on the 7th day post-recruitment, whichever occurs first.
Phase 2
Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period.
Berg Balance Scale (BBS)
Phase 1
Assessments will be conducted at the time of recruitment & at hospital discharge, or on the 7th day post-recruitment, whichever occurs first.
Phase 2
Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period.
Modified Rankin Scale(mRS)
Phase 1
Assessments will be conducted at the time of recruitment & at hospital discharge or on the 7th day post-recruitment, whichever occurs first. A follow-up assessment will be performed 1 month after this time point, via a telephonic interview.
Phase 2
Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period. A follow-up assessment will be performed 1 month after completion of the 3-week intervention, via a telephonic interview.
Motor Assessment Scale (MAS)
Phase 1
Assessments will be conducted at the time of recruitment & at hospital discharge, or on the 7th day post-recruitment, whichever occurs first.
Phase 2
Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period.
2 Minute step test (2MST)
Phase 1
Assessments will be conducted at the time of recruitment & at hospital discharge, or on the 7th day post-recruitment, whichever occurs first.
Phase 2
Assessments will be conducted at the time of recruitment & at the end of the 3-week intervention period.
Physical Activity in Inpatient Rehabilitation Assessment
(PAIR)
Phase 1
from the time of recruitment until hospital discharge or up to 7 days, whichever occurs first.
Phase 2
from the time of recruitment up to 3 days
Stroke Physical Activity Questionnaire (SPAQ)
Phase 1
A follow-up assessment will be conducted 1 month after the second assessment time point (i.e., hospital discharge or the 7th day post-recruitment, whichever occurs first), via a telephonic interview.
Phase 2
A follow-up assessment will be conducted 1 month after the second assessment time point (i.e., completion of the 3-week intervention period), via a telephonic interview.
Target Sample Size
Total Sample Size="105" Sample Size from India="105" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Introduction
Stroke is a significant public health problem in low-middle-income countries, including India. Inpatients in acute care settings are particularly vulnerable to the adverse effects of physical inactivity, which can exacerbate post-stroke disabilities, increase the risk of stroke recurrence, and prolong hospital stays. Despite the recommendations, many stroke patients tend to lead a sedentary lifestyle, spending prolonged periods sitting down each day.
Objectives
To estimate the levels of physical activity using a thigh-worn triaxial accelerometer in patients with acute and subacute stroke and to determine the effectiveness of a game-based rehabilitation on sedentary behavior and physical activity in patients with acute and subacute stroke.
Methods
The study’s first phase involves estimating physical activity levels and sedentary behavior in patients with acute and subacute stroke. Wherein the patients will be screened at 3 different settings in India, and those meeting the eligibility criteria will undergo an assessment and be given an activity log and a thigh-worn triaxial accelerometer, which they will need to wear for 7 days or until discharge, followed by assessment and a follow-up assessment at 1-month post-discharge.
The second phase constitutes the recruitment of patients fulfilling the objective of this phase, followed by baseline assessment along with completion of activity log and accelerometer recording followed up by randomization into experimental and control groups The experimental group will receive game-based rehabilitation, and the control group will receive conventional physiotherapy for 3 weeks, with an assessment along with completion of activity log and accelerometer data recording for a minimum of 3 days at the end of the 3rd week. after this, both the groups will be given the context-specific exercise program as a home-based therapy which they will have to perform up to the final assessment at 1 month
Results
Objective assessment and estimation of PA levels and delivery of game-based rehabilitation in the early stroke care periods may minimize the secondary effects of sedentary behavior and help in planning to meet the recommended levels of PA, reducing the burden in LMICs.
Conclusion
This strategy may enhance physical activity, directly contributing to and promoting healthier lifestyles. Also, this can potentially reduce healthcare costs. The utilization of accelerometers and gaming technology for health-related purposes demonstrates the potential of technological advancements to tackle health issues and enhance the overall quality of life.