| CTRI Number |
CTRI/2026/04/108486 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| 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
|
Robotic and modified movement therapy on hand functions among brain stroke patients |
|
Scientific Title of Study
|
Effects of robot assisted therapy and modified constraint induced movement therapy on hand functions among stroke patients |
| 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 Sam Thamburaj |
| Designation |
Professor |
| Affiliation |
VINAYAKA MISSION’S COLLEGE OF PHYSIOTHERAPY |
| Address |
PRINCIPAL,DEPARTMENT OF PHYSIOTHERAPY
VINAYAKA MISSION’S COLLEGE OF PHYSIOTHERAPY
SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
|
| Fax |
|
| Email |
principal.vmcpt@vmu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ponmani |
| Designation |
Research scholar |
| Affiliation |
VINAYAKA MISSION’S COLLEGE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY
VINAYAKA MISSION’S COLLEGE OF PHYSIOTHERAPY
SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
8940666650 |
| Fax |
|
| Email |
ponmanimpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ponmani |
| Designation |
Research scholar |
| Affiliation |
VINAYAKA MISSION’S COLLEGE OF PHYSIOTHERAPY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY
VINAYAKA MISSION’S COLLEGE OF PHYSIOTHERAPY
SALEM
TAMIL NADU
636308
India |
| Phone |
8940666650 |
| Fax |
|
| Email |
ponmanimpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaga Missions College of Physiotherapy Room No 3, Department of Physiotherapy, NH-47, Sankari Main Road,. Periya Seeragapadi,. Salem-636 308 |
|
|
Primary Sponsor
|
| Name |
Vinayaga Missions College of Physiotherapy |
| Address |
Room No 3, Department of Physiotherapy, NH-47, Sankari Main Road,. Periya Seeragapadi,. Salem-636 308 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sam Thamburaj |
VINAYAKA MISSION’S COLLEGE OF PHYSIOTHERAPY |
DEPARTMENT OF PHYSIOTHERAPY
VINAYAKA MISSION’S COLLEGE OF PHYSIOTHERAPY
SALEM
Salem
TAMIL NADU |
9003598038
principal.vmcpt@vmu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL THERAPY |
SOFT TISSUE MOBILIZATION, JOINT MOBILIZATION, FACILITATION OF MUSCLE ACTIVITY/MOVEMENT,POSITIONING, SPECIFIC SENSORY INPUT, SPLINTING TECHNIQUES,EXERCISE TO INCREASE STRENGTH, BALANCE AND MOBILITY INCORPORATING UPPER LIMB ACTIVITY.4 hours per day every day for 2 weeks |
| Intervention |
MODIFIED CONSTRAINT INDUCED MOVEMENT THERAPY |
Unaffected limb Constrained using restrictive mitten 4 hours per day every day for 2 weeks. Activities. |
| Intervention |
Robot assisted Therapy |
Task specific activities using upper limb robots for 30 MINUTES , 5 TIMES PER WEEK FOR 2 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Sub acute stroke patients between the age group of 35 and 45 years are only included.
Sub acute Hemiparetic stroke patients having spasticity grading modified Ashworth scale between 1 to 2.
Hemiparetic stroke patients having Brunnstrom stages of stroke recovery from stage 2 to stage 5.
Participants with single stroke history.
Participants having the ability to actively extend 10 degrees at the wrist, metacarpo phalangeal Joint and inter phalangeal joint
|
|
| ExclusionCriteria |
| Details |
Participants with serious cognitive deficits
Participants who are non cooperative, dropouts and less than 23 points in Mini Mental State Examination
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fugl – Meyer (U-L)(Upper – Limb)
Hole Peg test
|
baseline, after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Independence Measure (FIM) |
baseline, after 2 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
AIM OF THE STUDY The purpose and aim of the study is to find the effects of Robot Assisted Therapy and modified Constraint Induced Movement Therapy on hand functions among stroke patients. NEED OF THE STUDY The principles of neuroplasticity on hand recovery after stroke which includes high intensity practice, repetitive practice of functional tasks will be achieved in many Therapies. The affected hand recovery after stroke will remains plateau in function after 6 months of stroke. Therefore it is a need to find the effective therapy in additional to conventional therapy on motor functions recovery of the affected hand after stroke. OBJECTIVES To improve the hand functions (motor) among stroke patients by Conventional Therapy, Modified constraint induced movement therapy with conventional therapy,Robot assisted therapy with conventional therapy. To compare the effects of modified constraint induced movement therapy and conventional therapy over conventional therapy alone. To compare the effects of Robot assisted therapy and conventional therapy over conventional therapy alone. To compare the effects modified constraint induced movement therapy and conventional therapy over conventional therapy and Robot assisted therapy. HYPOTHESIS There may be no significant difference in the improvement of hand functions (motor) among stroke patients who receive conventional therapy ,Modified constraint induced movement therapy with conventional therapy,Robot assisted therapy with conventional therapy. There may be a significant difference in the improvement of hand functions (motor) among stroke patients who receive Modified constraint induced movement therapy with conventional therapy and conventional therapy alone, Robot assisted therapy with conventional therapy and conventional therapy alone, Modified constraint induced movement therapy with conventional therapy and Robot assisted therapy with conventional therapy. |