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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  
Name  Address 
NA  NA 
 
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  
Status 
Not Applicable 
 
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.
 
 
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  
Outcome  TimePoints 
NA  NA 
 
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.

 
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