| CTRI Number |
CTRI/2025/08/093859 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Soft Robotic Glove Therapy with Mental Imagery versus Physical Practice with Mental Imagery for Post-Stroke Hand Recovery. |
|
Scientific Title of Study
|
Effectiveness of Soft Robotic Glove Therapy with Mental Imagery versus Physical practice with Mental Imagery on post-stroke hand recovery- 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 |
Ritika Chauhan |
| Designation |
Postgraduate student (Master of ocupational therapy- Neurology) |
| Affiliation |
ISIC Institute of Rehabilitation sciences |
| Address |
ISIC Institute of Rehabilitation Sciences, opp. Vasant valley school, IAA colony sector c, Vasant kunj South West DELHI 110070 India |
| Phone |
9560172751 |
| Fax |
|
| Email |
Ritikachauhan345@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Lipika Malik |
| Designation |
Assistant Professor |
| Affiliation |
ISIC Institute of Rehabilitation sciences |
| Address |
ISIC Institute of Rehabilitation Sciences, opp. Vasant valley school, IAA colony sector c, Vasant kunj South West DELHI 110070 India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Lipika Malik |
| Designation |
Assistant Professor |
| Affiliation |
ISIC Institute of Rehabilitation sciences |
| Address |
ISIC Institute of Rehabilitation Sciences, opp. Vasant valley school, IAA colony sector c, Vasant kunj South West DELHI 110070 India |
| Phone |
9999931199 |
| Fax |
|
| Email |
lipika.otist@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre- Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi, South Delhi, 110070, India |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Center |
| 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 Lipika Malik |
Indian Spinal Injuries Center |
PMR department, Ground floor, ISIC, Sector-C, Vasant Kunj, Delhi- 110070 South West DELHI |
9999931199
lipika.otist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indian Spinal Injuries Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I60-I69||Cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Mental imagery + Soft robotic glove assisted therapy)
|
20 mins :Mental imagery, consists of
3 min- relaxation exercises,
15 min- MI guided practice, and
2 min- refocusing
(5 min: mid session break)
15 min: soft robotic glove-based therapy.
Tasks involved:
Individual flexion and extension of all fingers,
Making a fist and spreading of hands,
Pinch movements- index finger pinch, middle finger pinch, ring finger pinch, little finger pinch,
Functional tasks- Grab a ball,
Hold a dice (two- finger pinch), Hold the block (three- finger pinch).
|
| Comparator Agent |
Group B (Mental imagery + Physical practice) |
20 min: Mental imagery consists of
3 min- relaxation exercises,
15 min- MI guided practice and
2 min- refocusing
( 5 min: mid-session break)
15 min: physical practice.
Tasks involved:
Flexion and extension of thumb,
Abduction and adduction of all digits,
Making a fist and spreading of hand,
Moving extended fingers backwards and forwards,
Moving hand between ulnar and radial deviation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Stroke duration of more than 4 weeks.
MOCA score of greater than or equal to 26 for good cognitive health.
Ability to imagine motor acts; completion of Kinesthetic and visual imagery questionnaire 10 with score of more than or equal to 25.
Modified Ashworth Scale score of less than or equal to 2 for the affected hand.
Fugl Meyer Assessment- Upper Extremity score of greater than or equal to 50.
|
|
| ExclusionCriteria |
| Details |
Any pre diagnosed neurological and psychiatric disorder other than stroke.
Individuals who have joint contracture, musculoskeletal pain or fracture in hand or wrist.
Individuals with perceptual deficits such as neglect and apraxia.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fugl Meyer assessment upper extremity,
Box and Block test, and
Jebsen Taylor Hand function test. |
one Day before intervention and a day after 4 weeks of intervention. |
|
|
Secondary Outcome
|
|
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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
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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 is a leading cause of long term disability, with many survivors experiencing persistent sequelae that impair hand function and limit independence in activities of daily living (ADLs). Mental imagery is the mental rehearsal of a physical task to enhance motor skills without actual movement. As it activates brain areas similar to physical practice, their combination effectively improves motor recovery after stroke. Stroke patients with hand impairments reported positive outcomes using a soft robotic glove. These gloves significantly improved strength, coordination, and dexterity, helping patients regain independence and serving as a promising adjunct in hand rehabilitation. While robotic gloves offer significant motor recovery benefits, they may not always outperform conventional physical practice. However, integrating them with mental imagery can further enhance functional improvement. This study would compare soft robotic glove with mental imagery to physical practice with mental imagery for post-stroke hand recovery, aiming to identify the more effective approach for better clinical outcomes. The study design will be Experimental and 30 participants will be recruited from PMR department, ISIC, New- Delhi. The participants age will be between 18 to 80 years, duration of more than 4 weeks post stroke, with MAS score of less than or equal to 2 for affected hand, ability to follow and understand commands and ability to imagine motor acts with KVIQ10 score of greater than or equal to 25. The exclusion criteria will be individuals having any pre diagnosed neurological and psychiatric disorder other than stroke. Individuals who have joint contracture, musculoskeletal pain or fracture in hand or wrist and individuals with perceptual deficits such as neglect and apraxia. Pre intervention assessment will be done using Fugl meyer assessment upper extremity, box and block test and Jebsen Taylor hand function test. Participants will then be divided into two groups (Group A and Group B) with 15 participants in each group. Group A will receive Mental imagery + Physical practice and Group B will receive Mental imagery + Soft robotic glove based therapy. The training program will be given for 35 mins, 3 sessions per week for 4 weeks. The post intervention assessment will be done after 4 weeks of intervention using the same outcome measures i.e. Fugl meyer assessment upper extremity, box and block test and Jebsen Taylor hand function test. |