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

Not Applicable

Recruiting

• Conditions: Stroke; Healthy Adults
• Interventions: Other: Mirror Therapy + Electrical Stimulation; Other: Mirror Therapy; Other: Mirror Therapy + Binaural Beat

• Registration Number: NCT06011018
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-25
• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-30
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. First occurrence of stroke≧ 6 months
2. Mini-mental state examination≧24
3. Modified Ashworth's scale of ankle muscle ≦3
4. Sit independently≧30 mins
5. Brunnstrom stage ≧3
6. Aged between 20 and 80 years

Exclusion Criteria

1. Speech impairment
2. Hearing impairment
3. Visual impairment
4. Other orthopedic diseases or nerve damage
5. Complete sensory impairment
6. Pacemaker or metal implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirror Therapy + Electrical Stimulation	Mirror Therapy + Electrical Stimulation	-
Mirror therapy	Mirror Therapy	-
Mirror Therapy + Binaural Beat	Mirror Therapy + Binaural Beat	-

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer assessment, lower extremity	10minutes	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.

Secondary Outcome Measures

Name	Time	Method
Modified ashworth scale	5minutes	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.
The postural assessment scale for stroke patients	10 minutes	Higher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke.
Timed up and go test	5minutes	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.
Barthel index	5minutes	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.

Trial Locations

Locations (1)

Kaohsiung Medical University, Department of Physical Therapy; 🇨🇳 Kaohsiung, Taiwan