| CTRI Number |
CTRI/2025/08/093244 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| 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
|
To compare effectiveness of visuoproprioceptive illusion of movement and motor imagery versus conventional physiotherapy on hand motor functions and spasticity among sub acute strokes subjects. |
|
Scientific Title of Study
|
To compare effectiveness of visuoproprioceptive illusion of movement and motor imagery versus conventional physiotherapy on hand motor functions and spasticity among subacute stroke subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa uniyal |
| Designation |
Research scholar |
| Affiliation |
phd scholar,sgrr university dehradun |
| Address |
SGRR university of medical and health sciences Patel nagar Dehradun ,department of physiotherapy.
S.G.R.R. University, department of physiotherapy, Patel nagar, Dehradun.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
08477023611 |
| Fax |
|
| Email |
uniyalricha6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr niraj kumar |
| Designation |
Professor |
| Affiliation |
professor ,department of physiotherapy sgrr university |
| Address |
SGRR university of medical and health sciences Patel nagar Dehradun
Department of physiotherapy, sgrr university Patel nagar, Dehradun.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
nirajkumar@sgrrmc.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr niraj kumar |
| Designation |
Professor |
| Affiliation |
professor ,department of physiotherapy sgrr university |
| Address |
SGRR university of medical and health sciences, department of physiotherapy, Patel nagar, Dehradun
SGRR university of medical and health sciences, department of physiotherapy, Patel nagar, Dehradun.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
nirajkumar@sgrrmc.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 niraj kumar |
shri mahant indiresh hospital patelnagar dehradun |
department of physiotherapy, basement ,north block,shri mahant indiresh hospital Patel nagar Dehradun.
Dehradun
UTTARANCHAL |
7895795277
nirajkumar@sgrrmc.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shri guru ram rai institute of medical and health sciences patel nagar dehradun |
Approved |
| Institutional ethics committee Shri guru ram rai institute of medical and health sciences patel nagar dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G460||Middle cerebral artery syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare effectiveness of visuo proprioceptive illusion of movement and motor imagery versus conventional physiotherapy on hand motor functions and spasticity among sub acute stroke subjects |
Type: Intervention
Name: Visuo proprioceptive illusion with virtual motor imagery
Description: Participants will receive tendon vibration induced movement illusion combined with virtual reality based motor imagery tasks using Oculus Meta 3 VR headset. Vibration at 100 Hz applied sequentially to forearm, palm, thenar eminence, first web space, and dorsal hand, each for 10 seconds with 10 seconds rest, 30 repetitions. Sessions last 45 minutes, 5 days per week for 6 weeks.
Week 1–3: motor imagery based grip and pinch tasks with progressive difficulty.
Week 4–6: active movement tasks with action observation.
Duration: 6 weeks, 5 sessions per week, 45 minutes per session.
Arm 2 – Control Group
Type: Comparator
Name: Standard rehabilitation therapy
Description: Participants will receive conventional upper limb rehabilitation including warm up with passive and active range of motion exercises, grip and pinch strength training with putty and grippers, and dexterity training with peg boards and functional tasks. Each session is 45 minutes, 5 days per week for 6 weeks.
Duration: 6 weeks, 5 sessions per week, 45 minutes per session.
|
| Comparator Agent |
Visuo proprioceptive illusion with virtual motor imagery Description: Participants will receive tendon vibration induced movement illusion combined with virtual reality based motor imagery tasks using Oculus Meta 3 VR headset |
Participants will receive conventional upper limb rehabilitation including warm up with passive and active range of motion exercises, grip and pinch strength training with putty and grippers, and dexterity training with peg boards and functional tasks. Each session is 45 minutes, 5 days per week for 6 weeks. Duration: 6 weeks, 5 sessions per week, 45 minutes per session. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
First-ever stroke
Subacute phase
No cognitive impairments
Moderate spasticity and hand function loss
|
|
| ExclusionCriteria |
| Details |
Severe spasticity
Cognitive impairments
Chronic stroke
Hemodynamically unstable
Other neurological disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hand grip strength
Hand pinch strength
Hand dexterity
Spasticity
Activities of daily life
Stroke quality assessment |
baseline
3rd week
end of 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hand Grip Dynamometer
Pinch Gauge Dynamometer
Block and Box Test (BBT)
Nine-Hole Peg Test
Stroke Specific Quality of Life Scale (SS-QOL)
Fugl-Meyer Assessment
Tardieu scale
|
baseline
3 weeks
end of 6 weeks |
Activities of daily life
Stroke quality assessment |
baseline
3rd week
end of 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/10/2025 |
| 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="2"
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
|
this study aims to compare the effectiveness of a combined intervention using visuo proprioceptive illusion of movement and motor imagery with conventional physiotherapy in improving hand motor functions and reducing spasticity in individuals recovering from a subacute stroke .the study will involve participants within the subacute phase post stroke and assess changes in hand function and spasticity levels using standadized clinical outcome measures. the goal is to determine whether engaging the brain through illusion based and mental imagery techniques affers superior benifits over traditional rehabilitation methods. |