| CTRI Number |
CTRI/2025/12/099238 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“Which Therapy Improves Arm Movement After Stroke?” |
|
Scientific Title of Study
|
‘Tech-driven Recovery: Evaluating Digital Mirror Therapy Against Task-oriented Training For Upper Limb Rehabilitation In Subacute Stroke Patients’- A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vamja Dhruv Gulabbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy RK University |
| Address |
School of Physiotherapy,RK University, Bhavnagar Highway, Kasturbadham, Rajkot
Rajkot GUJARAT 360020 India |
| Phone |
8160244489 |
| Fax |
|
| Email |
dvamja452@rku.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shrikant Savaniya |
| Designation |
Assistant Professor School of Physiotherapy RK. University |
| Affiliation |
School of Physiotherapy RK University |
| Address |
School of Physiotherapy,RK University, Bhavnagar Highway, Kasturbadham, Rajkot
Rajkot GUJARAT 360020 India |
| Phone |
8980748154 |
| Fax |
|
| Email |
shrikant.savaniya@rku.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Vamja Dhruv Gulabbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy RK University |
| Address |
School of Physiotherapy,RK University, Bhavnagar Highway, Kasturbadham, Rajkot
Rajkot GUJARAT 360020 India |
| Phone |
8160244489 |
| Fax |
|
| Email |
dvamja452@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Vamja Dhruv Gulabbhai School of Physiotherapy,RK University, Bhavnagar Highway, Kasturbadham, Rajkot - 360020, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Vamja Dhruv Gulabbhai |
| Address |
School of Physiotherapy,RK University, Bhavnagar Highway, Kasturbadham, Rajkot - 360020, Gujarat, India |
| 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 |
| Vamja Dhruv Gulabbhai |
RK Physiotherapy Rehabilitation and Research Centre |
Physiotherapy Department Room no 1 Opp Meghani Rangbhavan Bhaktinagar Circle Rajkot Gujarat India Rajkot GUJARAT |
8160244489
dvamja452@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of Physiotherapy RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digital Mirror Therapy |
Digital Mirror Therapy is a rehabilitation method using a tablet based virtual mirror display that shows the unaffected upper limb to simulate movement of the affected limb. Participants will perform tasks including peg transfers, card flipping, object manipulation, and wrist and hand movements. Sessions will last thirty to forty five minutes, five days per week, for four weeks. The therapy aims to improve upper limb motor function by stimulating the sensorimotor cortex in subacute stroke patients. |
| Comparator Agent |
Task Oriented Training |
Task Oriented Training includes repetitive, goal directed functional tasks to improve upper limb motor control. Participants will practice activities such as pegboard transfer, block stacking, and card flipping. Sessions will last thirty to forty five minutes, five days per week, for four weeks. The training aims to enhance motor relearning and functional use of the affected upper limb in subacute stroke patients. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
MCA strokes patients those who are confirmed with CT or MRI
Age between 35 to 60
Unilateral stroke of three month to six month
Able to understand and follow the instructions
Patients who meet the inclusion criteria and provide written informed consent will be included in the study.
Fugl-Meyer Assessment-Upper Extremity (FMA-UE) motor score between 19 and 58
|
|
| ExclusionCriteria |
| Details |
Patients with other neurological conditions like Parkinson’s disease
Musculoskeletal problems (deformity, recent fractures)
All type of visual problems that cannot be corrected
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fugl-Meyer Assessment for upper extremity (FMA-UE)
|
Baseline (Day 0) and Post-intervention (Week 4)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
31/12/2025 |
| 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="0" Months="6" 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
|
Stroke commonly causes long term upper limb disability and only a small percentage of patients regain full function. Neuroplasticity based rehabilitation during the subacute stage is important for recovery. Task Oriented Training involves repetitive goal directed functional tasks, while Digital Mirror Therapy uses virtual mirror feedback to stimulate the sensorimotor cortex. Evidence comparing these two approaches in subacute stroke is limited, creating a need for this study. This prospective randomized controlled trial will include thirty two subacute stroke patients aged thirty five to sixty years who meet the inclusion criteria. Participants will be randomly allocated into two parallel groups using simple computer generated randomization. Group A will receive Task Oriented Training involving functional tasks such as pegboard transfer, block stacking and card flipping. Group B will receive Digital Mirror Therapy using a tablet based virtual mirror display of the unaffected limb performing tasks such as peg transfers, card flipping and object manipulation. Both groups will receive sessions of thirty to forty five minutes, five days per week for four weeks. Pre test assessment will include the Fugl Meyer Assessment for the upper extremity performed one day before intervention. Post test assessment will be done one day after completing the four week program. The primary outcome measure is the Fugl Meyer Assessment Upper Extremity score. The study aims to compare the effectiveness of Task Oriented Training and Digital Mirror Therapy in improving upper limb motor function in subacute stroke patients and to determine which approach offers better functional recovery. |