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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Healthy Adults
• Intervention / Treatment: Other: Mirror Therapy; Other: Mirror Therapy + Electrical Stimulation; Other: Mirror Therapy + Binaural Beat

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LIN JAU HONG, Ph.D.; Phone Number: 0929393300; Email: jhlin@kmu.edu.tw
• Study Contact Backup: Name: LIN YEN YU, Master's degree; Phone Number: 0988392631; Email: yenyu.lin88@yahoo.com

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University, Department of Physical Therapy
    • Contact: LIN JAU HONG, Ph.D.; Phone Number: 0929393300; Email: jhlin@kmu.edu.tw
    • Contact: LIN YEN YU, Master's; Phone Number: 0988392631; Email: yenyu.lin88@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirror therapy	Other: 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
Experimental: Mirror Therapy + Electrical Stimulation	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.
Experimental: Mirror Therapy + Binaural Beat	Other: Mirror Therapy + Binaural Beat; Same as the mirror therapy protocol. Listen to music (pink noise), with 14Hz binaural beat stimulation

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography	Electroencephalography is used obtain power data of total μ (8-12Hz), lower μ (8-10Hz), and upper μ (10-12Hz). μ suppression→ a negative value (<0) indicates inhibition of μ waves, indicating activation in the motor cortex(Bae et al., 2012).	20minutes

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Chair: LIN JAU HONG, Ph.D., Kaohsiung Medical University,department of Physical Therapy

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Investigative Techniques; Therapeutics; Physical Therapy Modalities; Rehabilitation; Physical Stimulation; Mirror Movement Therapy; Electric Stimulation
• Other Study ID Numbers: KMUHIRB-F(II)-20220175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: During the study period, to ensure subject privacy, only the implementers of this research project, monitors, regulatory authorities, and the institutional review board of our institution have the authority to access the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No