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临床试验/CTRI/2025/08/093069
CTRI/2025/08/093069尚未招募不适用

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 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年8月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
Fugl-Meyer Assessment Upper Extremity(FMA-UE)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Fugl-Meyer Assessment Upper Extremity(FMA-UE)

时间窗: 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)

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Indian Spinal Injuries Center
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sunita Behera

Indian Spinal Injury Center- Institute of Rehabilitation Science

研究点 (1)

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