| CTRI Number |
CTRI/2025/12/099014 [Registered on: 12/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational therapy] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Task-Oriented Mental Practice versus Motor Relearning Program in improving upper limb function and daily living activities among individual with stroke |
|
Scientific Title of Study
|
Effect of Task-Oriented Mental Practice and Motor Relearning Program in enhancing upper limb function and daily living activities among individual with stroke: 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 |
Monika Sharma |
| Designation |
Postgraduate student (Master of occupational therapy) |
| Affiliation |
ISIC Institute of rehabilitation sciences |
| Address |
Indian spinal injuries center- Institute of rehabilitation sciences, 2nd floor
sector C vasant kunj
South West delhi
DELHI
110070
India
New Delhi
DELHI
110070
India |
| Phone |
9818589928 |
| Fax |
|
| Email |
monikasharma1m2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Vijay |
| Designation |
Associate professor |
| Affiliation |
ISIC Institute of rehabilitation sciences |
| Address |
Indian spinal injuries center- Institute of rehabilitation sciences, 2nd floor
sector C vasant kunj
South West delhi
DELHI
110070
India
New Delhi
DELHI
110070
India |
| Phone |
9910631430 |
| Fax |
|
| Email |
priyanka_vijay02@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Vijay |
| Designation |
Associate Professor |
| Affiliation |
ISIC Institute of rehabilitation sciences |
| Address |
ISIC Institute of Rehabilitation Sciences, Sector-C, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
9910631430 |
| Fax |
|
| Email |
priyanka_vijay02@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PMR department, ISIC Multispeciality Hospital, Ground floor, Sec-c, vasant Kunj, New Delhi-110070 |
|
|
Primary Sponsor
|
| Name |
ISIC Multispeciality Hospital |
| Address |
Sector- C, Vasant Kunj, New Delhi-110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyanka Vijay |
PMR Department, ISIC Multispeciality Hospital |
Ground Floor, ISIC Multispeciality Hospital, Sector-c, vasant Kunj
South West
DELHI |
9910631430
priyanka_vijay02@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indian Spinal Injuries Center Institutional Ethics Committee |
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 |
| Comparator Agent |
Motor Relearning Program |
Shoulder forward flexion Pushing the wall
Wrist extension and radial deviation Forearm supination Thumb opposition and palmar abduction Cupping of Hand Intervention will be provided for a period of 5 sessions per week for 4 weeks with each session lasting for 30 mins.
|
| Intervention |
Task oriented mental practice |
Taking out a small cup from a height one can reach from a sitting position Wiping the desk with a towel Fold towel turn once Picking up pen from table and draw two lines Intervention will be provided for a period of 5 sessions per week for 4 weeks with each session lasting for 30 mins.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with ischemic and hemorrhagic stroke
Duration of stroke- subacute phase (1-6 months post stroke
Brunnstrom stage 3 for hand
MOCA greater or equal to 26
Vividness of Movement Imagery Questionnaire- less than or equal to 2.26 (average)
|
|
| ExclusionCriteria |
| Details |
Recurrent cerebrovascular disease
Individual with any communication problems, perceptual & visual deficits
Excessive pain on paretic upper limb (scores more than 4 on VAS)
Individuals with any prediagnosed neurological conditions other than stroke
Individuals with any prediagnosed psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fugl-Meyer Assessment of motor function (U/E)
Functional Independence measure (FIM) |
Baseline (week 0), after 4 weeks, after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/12/2025 |
| 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 leads to upper limb impairment, reducing independence in daily activities and quality of life. Task Oriented Mental Practice improves motor skills by combining mental imagery of movements with actual physical practice. This helps stimulate neuroplasticity, leading to stronger cortical changes and better motor learning. The Motor Relearning Program focuses on practicing controlled muscle actions and improving movement components. It is based on the brain’s ability to reorganize and adapt, aiming to stimulate or optimize this capacity to enhance motor recovery. While both TOMP and MRP have been individually proven to be effective in improving upper limb function and enhancing activities of daily living in stroke survivors, limited research directly compares these interventions. This gap makes it difficult for clinicians to determine the more effective rehabilitation strategy. This study compares the effectiveness of Task Oriented Mental Practice and the Motor Relearning Program in improving upper limb functions and activities of daily living among individuals with stroke. The study will be conducted as an experimental trial with 30 subacute stroke participants from GIPMER & ISIC, New Delhi. Participants will be randomly assigned to either the TOMP group or the MRP group. Individuals will be aged 20 to 60 years, with a duration of 1 to 6 months post stroke, Brunnstrom Stage 3 of hand, MOCA score greater than or equal to 26, and VMIQ score less than or equal to 2.26. Exclusion criteria include recurrent strokes, severe pain, perceptual or visual deficits, and other neurological or psychiatric conditions. Interventions will be provided for 30 minutes per day, 5 days per week, for 4 weeks. Outcome measures include the Fugl Meyer Assessment Upper Extremity and the Functional Independence Measure. Assessments will be conducted before the intervention(baseline), after the 4 week intervention, and 6 weeks (follow up). |