| 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
|
|
|
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
|
|
|
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 stroke. 26 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. |