Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke

Study Overview
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Brief Summary
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This study aims to compare the effects of mirror therapy combined with either neuromuscular electrical stimulation or binaural beat stimulation on post-stroke lower limb motor function recovery. The study also explores the relationship between patients' cortical excitability and motor function improvement.

Official Title
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Comparison of Effects of Mirror Therapy Combined With Neuromuscular Electrical Stimulation or Binaural Beats Stimulation on Cortical Excitability, Heart Rate Variability and Lower Limb Motor Function in Patients With Stroke

Conditions
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Stroke, Healthy Adults

Intervention / Treatment
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* Other: Mirror Therapy
* Other: Mirror Therapy + Electrical Stimulation
* Other: Mirror Therapy + Binaural Beat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First occurrence of stroke≧ 6 months Mini-mental state examination≧24 Modified Ashworth's scale of ankle muscle ≦3 Sit independently≧30 mins Brunnstrom stage ≧3 Aged between 20 and 80 years Exclusion Criteria: Speech impairment Hearing impairment Visual impairment Other orthopedic diseases or nerve damage Complete sensory impairment Pacemaker or metal implants

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomly assigned treatment groups: Mirror Therapy Mirror Therapy + Electrical Stimulation Mirror Therapy + Binaural Beat
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirror therapy<br> | Other: Mirror Therapy<br>* Sitting, mirror place at the midline between the legs. Unaffected leg is placed in front of the mirror and perform ankle dorsiflexion exercises. Duration: 5 seconds, Rest: 5 seconds<br>|
| Experimental: Mirror Therapy + Electrical Stimulation<br> | Other: Mirror Therapy + Electrical Stimulation<br>* Same as the mirror therapy protocol. Affected leg: electrical stimulation on tibialis anterior muscle. Frequency: 35 Hz, Pulse width: 250µs, Duration: 5 seconds, Rest: 5 seconds.<br>|
| Experimental: Mirror Therapy + Binaural Beat<br> | Other: Mirror Therapy + Binaural Beat<br>* Same as the mirror therapy protocol. Listen to music (mozart's clarinex concerto in A major K622), with Alpha (8Hz) binaural beat stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer assessment, lower extremity | The Fugl-Meyer Assessment for lower extremity is a scale used to evaluate motor and functional recovery in patients with conditions like stroke. It measures muscle strength, movement control, coordination, and balance. Scores range from 0 (no movement) to 34 (full recovery). Higher scores indicate better recovery. | 10minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified ashworth scale | The Modified Ashworth Scale assesses muscle spasticity in conditions like stroke or cerebral palsy. Scores range from 0 to 4 or 5, indicating the severity of muscle resistance during passive movement. Higher scores mean more severe spasticity. It guides treatment and tracks progress. | 5minutes | 
| Timed up and go test | The Timed Up and Go (TUG) test assesses mobility by measuring the time it takes for someone to stand, walk a short distance, turn, and sit back down. Faster times suggest better mobility, while longer times may indicate mobility limitations or fall risk. It's a useful tool to evaluate functional capacity and guide interventions for improved mobility. | 5minutes | 
| The postural assessment scale for stroke patients | Higher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke. | 10 minutes | 
| Barthel index | The Barthel Index assesses a person's ability to independently perform daily activities. Scores range from 0 to 100, with higher scores indicating greater independence. | 5minutes |