| CTRI Number |
CTRI/2026/02/104061 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Intelligent Robot-Assisted Upper Limb Rehabilitation for Stroke Survivors |
|
Scientific Title of Study
|
Development and Evaluation of Intelligent Robot-Assisted Upper Limb Therapy System |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kishor Lakshminarayanan |
| Designation |
Associate Professor |
| Affiliation |
Vellore Institute of Technology |
| Address |
Room no 408 - Neurorehabilitation Lab, Pearl Research Park, School of Healthcare Science and Engineering, Vellore Institute of Technology,
Thiruvalam Road,
Katpadi, Vellore
Tamilnadu
Vellore
TAMIL NADU
632014
India |
| Phone |
9361013563 |
| Fax |
|
| Email |
kishor.ln@vit.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kishor Lakshminarayanan |
| Designation |
Associate Professor |
| Affiliation |
Vellore Institute of Technology |
| Address |
Room no 408 - Neurorehabilitation Lab, Pearl Research Park, School of Healthcare Science and Engineering, Vellore Institute of Technology,
Thiruvalam Road,
Katpadi, Vellore
Tamilnadu
Vellore
TAMIL NADU
632014
India |
| Phone |
9361013563 |
| Fax |
|
| Email |
kishor.ln@vit.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kishor Lakshminarayanan |
| Designation |
Associate Professor |
| Affiliation |
Vellore Institute of Technology |
| Address |
Room no 408 - Neurorehabilitation Lab, Pearl Research Park, School of Healthcare Science and Engineering,
Vellore Institute of Technology,
Thiruvalam Road,
Katpadi, Vellore
Tamilnadu
Vellore
TAMIL NADU
632014
India |
| Phone |
9361013563 |
| Fax |
|
| Email |
kishor.ln@vit.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, Government of India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR) |
| Address |
Indian Council of Medical Research
Department of Health Research
Ministry of Health and Family Welfare
Government of India, New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Kishor Lakshminarayanan |
Vellore Institute of Technology |
Room No 408 & 413I,
School of Healthcare Science and Engineering,
Pearl Research Park,
Vellore Institute of Technology,
Thiruvalam Road, Vellore,
Tamilnadu, India.
PIN - 632014
Vellore
TAMIL NADU |
09361013563
kishor.ln@vit.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects would have no UE or other neurological disorders and will be age and gender matched to the stroke patients. |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ETbot Intelligent Robot Assisted Upper Limb Rehabilitation |
ETbot based upper limb rehabilitation delivered using an end effector robotic system providing passive, active assisted and resistive therapy modes. Therapy sessions are conducted five days per week for six weeks with each session lasting approximately sixty to ninety minutes. During therapy EEG EMG and robotic kinetic and kinematic data are recorded to identify biomarkers of functional state and to develop an adaptive robotic decision making framework. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged eighteen years and above. Stroke participants with radiologically confirmed ischemic or hemorrhagic stroke with upper limb motor impairment of at least twelve weeks duration and Modified Ashworth Scale score less than or equal to two. Healthy adult volunteers with no history of neurological or musculoskeletal disorders and age and gender matched to the stroke participants. All participants must be able to understand instructions and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Individuals with neurological conditions other than stroke such as Parkinson disease or Alzheimer disease, severe orthopedic conditions affecting the upper limb, severe cognitive or communication impairment, uncontrolled medical illness, significant visual impairment affecting task performance, spatial neglect, inability to sit for therapy or assessment sessions, or unwillingness to participate. Healthy volunteers with any current or past neurological or upper limb musculoskeletal disorder are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification Of EEG EMG And Kinematic Biomarkers Associated With Post Stroke Upper Limb Function During Robot Assisted Therapy |
Baseline And During Therapy Sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Feasibility Of Robot Assisted Upper Limb Therapy
Development And Validation Of Adaptive Robotic Decision Framework
Changes In EEG EMG And Kinematic Measures During Therapy |
Baseline and During Therapy Sessions |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
27/02/2026 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kishor.ln@vit.ac.in].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to develop and evaluate an intelligent robot assisted upper limb rehabilitation system for individuals with stroke related motor impairment. The robotic system delivers passive active assisted and resistive upper limb exercises while recording brain muscle and movement related signals.
Twenty stroke survivors with upper limb weakness and twenty healthy adult volunteers will participate in the study. Stroke participants will undergo robot assisted therapy sessions five days per week for six weeks. Healthy volunteers will perform similar movement tasks for comparison of biological and movement related markers.
Clinical assessments along with electroencephalogram electromyography and robotic motion data will be collected to identify biomarkers associated with upper limb functional state after stroke. These data will be used to develop an adaptive robotic decision making framework that can personalize therapy based on individual responses.
The outcomes of this study are expected to improve understanding of recovery related biomarkers and support the development of intelligent rehabilitation technologies for stroke care. |