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Clinical Trials/CTRI/2025/08/093069
CTRI/2025/08/093069Not yet recruitingNot Applicable

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

Indian Spinal Injuries Center1 site in 1 country26 target enrollmentStarted: August 27, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
26
Locations
1
Primary Endpoint
Fugl-Meyer Assessment Upper Extremity(FMA-UE)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
35.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subacute phase (1-6 months), Brunnstrom stage of hand (BRS) between 1-
  • able to follow commands.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Fugl-Meyer Assessment Upper Extremity(FMA-UE)

Time Frame: 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

Barthel Index (BI)

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Indian Spinal Injuries Center
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Sunita Behera

Indian Spinal Injury Center- Institute of Rehabilitation Science

Study Sites (1)

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