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

NCT ID: NCT06011018

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2026-07-31

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.

Detailed Description

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Conditions

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Stroke Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned treatment groups:

1. Mirror Therapy
2. Mirror Therapy + Electrical Stimulation
3. Mirror Therapy + Binaural Beat
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mirror therapy

Group Type EXPERIMENTAL

Mirror Therapy

Intervention Type OTHER

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

Mirror Therapy + Electrical Stimulation

Group Type EXPERIMENTAL

Mirror Therapy + Electrical Stimulation

Intervention Type OTHER

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.

Mirror Therapy + Binaural Beat

Group Type EXPERIMENTAL

Mirror Therapy + Binaural Beat

Intervention Type OTHER

Same as the mirror therapy protocol. Listen to music (pink noise), with 14Hz binaural beat stimulation

Interventions

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Mirror Therapy

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

Intervention Type OTHER

Mirror Therapy + Electrical Stimulation

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.

Intervention Type OTHER

Mirror Therapy + Binaural Beat

Same as the mirror therapy protocol. Listen to music (pink noise), with 14Hz binaural beat stimulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LIN JAU HONG, Ph.D.

Role: STUDY_CHAIR

Kaohsiung Medical University,department of Physical Therapy

Locations

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Kaohsiung Medical University, Department of Physical Therapy

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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LIN JAU HONG, Ph.D.

Role: CONTACT

0929393300

LIN YEN YU, Master's degree

Role: CONTACT

0988392631

Facility Contacts

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LIN JAU HONG, Ph.D.

Role: primary

0929393300

LIN YEN YU, Master's

Role: backup

0988392631

Other Identifiers

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KMUHIRB-F(II)-20220175

Identifier Type: -

Identifier Source: org_study_id

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