FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093069 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
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   A study to compare the effectiveness of targeted muscle Functional electrical stimulation with motor relearning program versus conventional therapy with placebo functional electrical stimulation 
Scientific Title of Study   Effect of integrated approach of motor relearning driven Functional Electrical Stimulation and Motor Relearning Program for upper limb function in 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  Sunita Behera  
Designation  Postgraduate student (Master in Occupational Therapy) 
Affiliation  Indian Spinal Injury Center- Institute of Rehabilitation Science  
Address  Indian Spinal Injury Center - Institute of Rehabilitation Science
Sector- C, Vasant Kunj New Delhi
South West
DELHI
110070
India 
Phone  9777763018  
Fax    
Email  sb63018@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Vijay 
Designation  Associate Professor  
Affiliation  Indian Spinal Injury Center-Institute of Rehabilitation Science  
Address  Indian Spinal Injury Center - Institute of Rehabilitation Science , Sector-C , Vasant Kunj! Delhi- 110070
Sector- C Vasant Kunj New Delhi
South West
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  Indian Spinal Injury Center-Institute of Rehabilitation Science  
Address  Indian Spinal Injury Center - Institute of Rehabilitation Science , Sector-C , Vasant Kunj! Delhi- 110070
Sector- C Vasant Kunj New Delhi
South West
DELHI
110070
India 
Phone  9910631430  
Fax    
Email  priyanka_vijay02@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Spinal Injuires Center 
 
Primary Sponsor  
Name  Indian Spinal Injuries Center 
Address  PMR department, Ground Floor, Sec-c, Vasant Kunj, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  Indian Spinal Injuries Center  PMR department, Ground floor, Indian spinal injuries center, Sector - C, Vasant Kunj, new delhi
South West
DELHI 
9910631430

priyanka_vijay02@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional therapy with sham Functional electrical stimulation  Conventional therapy (30 minutes) will include weight bearing activities, PROM exercises, upper limb activities using departmental rehabilitation tools. Sham FES (15 Minutes) will be set at a frequency of 0. Intervention will be provided for a period of four weeks, 45 minutes per session for 5 days a week  
Intervention  Motor Relearning Program and functional electrical stimulation  Motor relearning program (30 Minutes) include Opening and closing lid of the bottle, picking up the glass of water and drink it, reach and manipulate the glass of water in different direction and drink it, transferring the small object from one container to another, turning door knob and pages of book. Functional electrical stimulation (15 minutes) will be applied on missing component of the performance. Intervention will be provided for a period of four weeks, 45 minutes per session for 5 days a week  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subacute phase (1-6 months),
Brunnstrom stage of hand (BRS) between 1-4.
able to follow commands 
 
ExclusionCriteria 
Details  Participants with fracture or dislocation of upper limb with any peripheral vascular disease,
Conditioning contraindicated to electrical stimulation like implants electric pacemaker ,
Sever cardiac arrhythmia,
Individual with uncontrolled hypertension and any pre diagnosed neurological conditions other than stroke.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Fugl-Meyer Assessment Upper Extremity(FMA-UE)
Barthel Index (BI) 
Baseline before intervention, post-test 1 will be after 4 weeks of intervention & post test 2 will be after 2 weeks of post test 1 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   27/08/2025 
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="9"
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 major global health issue and a leading cause of adult disability, especially due to upper limb motor impairments. About 5.5 million people died because of stroke and most stroke survivors experience long-term upper limb dysfunction, which significantly affecting daily living activities.[1] Various rehabilitation methods exist, including motor relearning programs (MRP) and electrical stimulation. This study explore the comparative effect between MRP with electrical stimulation  versus conventional therapy with electrical stimulation for better upper limb recovery in individual with sub acute stroke, a key phase for recovery due to neuroplasticity. It examine how motor relearning program (MRP) enhances upper limb function through task specific training while functional electrical stimulation (FES) complements it by activating targeted muscles to restore motor skill and improve functional ability. so the objective of the current study is to compare the effectiveness of an integrated approach using the motor relearning program combined with functional electrical stimulation (FES) versus conventional therapy combined with FES for upper limb function in individual with stroke26  participants with subacute phase of stroke will be recruited from the age group of 35-65 years having Brunnstrom stage between 1 to 4 for hand , ability to understand and follow commands. The exclusion criteria will be Participants with fracture or dislocation of upper limb with any peripheral  vascular disease, condition that contraindicated to electrical stimulation like implants electric pacemaker , severe cardiac arrhythmia ,individual with Uncontrolled hypertension and any pre diagnosed neurological condition other than stroke.

Pre-intervention assessment will be done using Fugl-Meyer Assessment of motor function-Upper extremity and The Barthel Index scale. Participants will then be divided into two groups (Group A and Group B) with 13 participants in each group. Group A will receives motor relearning program with functional electrical stimulation (Frequency: 20– 50 Hz. Activities program included –wrist extension, grasp and release training, pinch grip practice, simulated functional task (holding a cup , turning doorknob, lifting a small object). Group B will receive conventional therapy with sham functional electrical stimulation( frequency will be set to 0, same activities will be provided as GROUP A).  The training program will be given for 45 minutes, 5 days a week for 4 weeks. Then the post intervention assessment will be done after 4 weeks of intervention using same outcome measures i.e. FMA-UE and The Barthel Index.  Then the follow up assessment will be done after two weeks of post intervention assessment.

 
Close