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CTRI Number  CTRI/2024/12/078058 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Behavioral
Other (Specify) [Robot assisted movement therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the usefulness of home-based therapy using a robot after stroke 
Scientific Title of Study   Home-based robot-assisted upper-limb training for stroke in India 
Trial Acronym  HOMER 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sivakumar Balasubramanian 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of Bioengineering Christian Medical College Bagayam Vellore 632002 Tamil Nadu

Vellore
TAMIL NADU
632002
India 
Phone  04162285098  
Fax    
Email  siva82kb@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Sivakumar Balasubramanian 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of Bioengineering Christian Medical College Bagayam Vellore 632002 Tamil Nadu


TAMIL NADU
632002
India 
Phone  04162285098  
Fax    
Email  siva82kb@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Sivakumar Balasubramanian 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of Bioengineering Christian Medical College Bagayam Vellore 632002 Tamil Nadu


TAMIL NADU
632002
India 
Phone  04162285098  
Fax    
Email  siva82kb@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian Medical College Ludhiana will be one of the trial sites in this clinical study. Address: Brown Rd, CMC Campus, Ludhiana, Punjab 141008 
Christian Medical College Vellore will be one of the trial sites in this clinical study. Address: Ida Scudder Road, Vellore – 632004 Tamil Nadu, India. 
Manipal College of Health Professionals will be one of the trial sites in this clinical study. 
The montory support for the work comes from the ICMR Investigator Initiated Intermediate Grant. Address: V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India  
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  Ida Scudder Road, Vellore – 632004 Tamil Nadu, India. 
Type of Sponsor  Other [Society] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jeyaraj Pandiyan  Christian Medical College Ludhiana  Department- neurology Room number- 195 Christian Medical College Ludhiana, brown road, Ludhiana Punjab 141008.
Ludhiana
PUNJAB 		 9915784750

jeyarajpandian@hotmail.com 
Dr Sanjith Aron  Christian Medical College Vellore  A-402, Room 15, 4th floor, Department of Neurological Science, Christian Medical College Vellore Ranipet Campus
Vellore
TAMIL NADU 		 9894022395

sanjith@cmcvellore.ac.in 
Dr John Solomon  Manipal College of Health Professionals  Room no 302, Motor Control Training Unit, Department of Physiotherapy, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA 		 9945670671

john.solomon@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Research Committee (IRC) Manipal College of Health Professions  Approved 
INSTITUTIONAL REVIEW BOARD (IRB) OFFICE OF RESEARCH CHRISTIAN MEDICAL COLLEGE VELLORE, INDIA  Approved 
NSTITUTIONAL ETHICS COMMITTEE (IEC), BIOMEDICAL &HEALTH RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I63||Cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Robot assisted upper limb therapy at home  For the intervention group, patients and caregivers will receive an orientation to the standard ADL-based home therapy program and robot-assisted upper-limb training during an in-clinic session on day 0. The intervention will involve the use of two compact and portable rehabilitation robots – PLUTO and MARS. On day 1, PLUTO and MARS will be installed in the patients home, and the intervention will commence on day 2. During the first three days of the intervention, a study intervention therapist will visit the participants home to provide semi-supervised therapy using the ADL-based program, PLUTO, and MARS. On the third day, the intervention therapist will record a video of the patients ADL-based therapy and training sessions with PLUTO and MARS and leave the videos with the patient for use as instruction on how to carry out therapy by themselves. After the initial three days, participants will continue training independently with the assistance of their caregiver. They will be required to train six days per week for four weeks, dedicating at least 30 minutes per day to the ADL-based home therapy program, 30 minutes per day to MARS, and 60 minutes per day to PLUTO. Following the first three days, the intervention therapist will be available on call to address any adverse events experienced by the participant and to provide any necessary assistance or guidance regarding the use of the robotic devices. The number of technical assistance requests and the nature of the assistance provided will be recorded using a standard form. Patients and caregivers will be given a diary to keep track of their training duration, and exercise details for the ADL component of their training. To monitor progress and ensure support, the intervention therapist will conduct weekly voice or video calls with the participants, starting from the second week of the intervention. These calls will serve to identify and record any adverse events, as well as to discuss the participants overall progress and address any questions or concerns they may have. The discussions during these weekly calls will be documented. At the end of the four-week training period, the intervention therapist will visit the patients home to record a video of the patient performing the ADL therapy tasks and training exercises with PLUTO and MARS, and to carry out the post-intervention assessment (A1).  
Comparator Agent  Standard paper-based home therapy program  For the control group, a standard ADL-based home therapy program will be prescribed to the recruited patients. The patient and caregiver will receive an orientation for the home-therapy program during an in-clinic session on day 0, and the home-therapy program will be initiated from day 2. During the first three days, a study intervention therapist will visit the patients home to provide supervised ADL-based home therapy intervention, ensuring clarity regarding the exercises and tasks to be performed. On day 3, the therapist will also record a video of the patients therapy performance, which will be provided to the patient to use as an instruction for how to do the prescribed tasks/exercises as part of their home therapy. Following the initial three days, the patient will be required to train independently with the caregiver for a minimum of 120 minutes per day, six days per week, for four weeks. Training sessions can be divided into multiple sessions throughout the day, with each session lasting at least 30 minutes. Patients will be encouraged to exceed the 120-minute training requirement if feasible. From the fourth day onwards, at least one study investigator will be available on call to address any adverse events reported by the participants during their training sessions. Patients and caregivers will be given a diary to keep track of their training duration and exercise details. To monitor progress and address any concerns, the intervention therapist will conduct weekly voice or video calls with the participants, starting from the second week of the intervention. These calls will record any adverse events experienced by the participants and discuss their overall progress with the intervention. The discussions during these weekly calls will be documented.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  First-ever stroke leading to a moderate arm paresis (FMA greater than 50)
Between 30 to 90 days post-stroke
VFE greater than 3deg (needs to be checked)
Age greater than 45 years, with classical atherosclerotic risks for stroke
Sufficient cognitive abilities (MoCA score greater than 26)
Living in and around the hospital (less than 100km radius); discharged from the hospital and living at home.
Strokes included as per TOAST criteria: (1) Large-Artery atherosclerosis, (2) Cardio-embolism, (3) Small-vessel occlusion. 
 
ExclusionCriteria 
Details  Recurrent stroke or patient with pre-stroke MRS greater than or equal to 1
Not having a caregiver/supervisor at home
Severe post-stroke depression
Severe aphasia
Psychiatric disorders
Other conditions like acquired brain injury contribute to arm and hand impairment.
Other stroke complications, such peri arthritis, shoulder subluxation, and CRPS.
Any other medical condition that makes the patient unsuitable for upper-limb therapy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
All participants will be assessed by a blinded assessor at 3 time points:
A0: Before the start of the intervention.
A1: Immediately after the completion of the 4-week intervention.
A2: 6-month post-stroke time point of each study participant.

Fugl-Meyer Assessment (FMA) scale will be the primary outcome measure of the study. It will be assessed at all three assessment time points A0, A1, and A2. 		 All participants will be assessed by a blinded assessor at 3 time points:
A0: Before the start of the intervention.
A1: Immediately after the completion of the 4-week intervention.
A2: 6-month post-stroke time point of each study participant.

Fugl-Meyer Assessment (FMA) scale will be the primary outcome measure of the study. It will be assessed at all three assessment time points A0, A1, and A2. 
 
Secondary Outcome  
Outcome  TimePoints 
Action Research Arm Test
Robotic assessment with PLUTO & MARS
Arm use assessment using the wearable inertial sensors
Motor Activity Log
EuroQual (EQ-5D)
Subjective Index of Physical & Social Outcome (SIPSO)
Modified Rankin Scale
Complex Regional Pain Syndrome (CRPS)
Montreal Cognitive Assessment (MOCA)
Patient Health Questionnaire (PHQ9)
Caregiver Strain Index (CSI) 		 Baseline, after the intervention (four weeks), & six months after the start of the intervention. 
Adherence to therapy – based on usage data from the robots, & the training log diaries.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Semi-structured interview to evaluate their experience with home therapy 		 At the end of the intervention (four weeks). 
Clinical and technical support will be computed based on the number of times the participant called during the study, the reason for the call (Technical, Clinical), and the duration of the call
Adverse Events
Dropout questionnaire: If a participant withdraws from the study, the reason for dropout will be recorded. 		 Assessed during the intervention 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   01/04/2026 
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)  		 Not Yet Recruiting 
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 escalating demand for high-quality, intense therapy post-stroke to maximise recovery is a pressing challenge for India’s healthcare system. Modern approaches use technology to provide intense, assisted, engaging, and game-based arm/hand training that exploits the human brain’s inherent neuroplasticity to promote recovery. The use of technology enables the implementation of controlled therapy with high repetitions and intermittent clinician supervision, providing a practical and scalable solution to this problem. The Christian Medical College (CMC) Vellore, in collaboration with the Indian Institute of Technology (IIT) Madras, has developed two compact, portable robots – one for the arm and one for the hand – for home-based neurorehabilitation.

Recent preliminary work by CMC Vellore in home-based robot-assisted hand neurorehabilitation in stroke survivors has shown encouraging results by substantially augmenting therapy dosage in conjunction with large improvements in upper limb impairments. Building upon this initial success, we hypothesise that robot-assisted home therapy of both arm and hand functions in subacute stroke subjects will be feasible and improve both upper limb impairment and function beyond the minimum clinically important difference. This project aims to rigorously test this hypothesis, presenting the potential to revolutionise the landscape of neurorehabilitation service delivery in India.
 
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