NCT06011018

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
3mo left

Started Oct 2022

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Oct 2022Jul 2026

Study Start

First participant enrolled

October 25, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

3.8 years

First QC Date

August 21, 2023

Last Update Submit

August 27, 2025

Conditions

StrokeHealthy Adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Modified ashworth scale

    5minutes

  • Timed up and go test

    5minutes

  • The postural assessment scale for stroke patients

    10 minutes

  • Barthel index

    5minutes

Other Outcomes (1)

  • Electroencephalography

    20minutes

Study Arms (3)

Mirror therapy

EXPERIMENTAL
Other: Mirror Therapy

Mirror Therapy + Electrical Stimulation

EXPERIMENTAL
Other: Mirror Therapy + Electrical Stimulation

Mirror Therapy + Binaural Beat

EXPERIMENTAL
Other: Mirror Therapy + Binaural Beat

Interventions

Mirror TherapyOTHER

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
Mirror Therapy + Electrical StimulationOTHER

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 + Electrical Stimulation
Mirror Therapy + Binaural BeatOTHER

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

Mirror Therapy + Binaural Beat

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Speech impairment
  • Hearing impairment
  • Visual impairment
  • Other orthopedic diseases or nerve damage
  • Complete sensory impairment
  • Pacemaker or metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University, Department of Physical Therapy

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement TherapyElectric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeuticsPhysical StimulationInvestigative Techniques

Study Officials

  • LIN JAU HONG, Ph.D.

    Kaohsiung Medical University,department of Physical Therapy

    STUDY CHAIR

Central Study Contacts

LIN JAU HONG, Ph.D.

CONTACT

0929393300jhlin@kmu.edu.tw

LIN YEN YU, Master's degree

CONTACT

0988392631yenyu.lin88@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned treatment groups: 1. Mirror Therapy 2. Mirror Therapy + Electrical Stimulation 3. Mirror Therapy + Binaural Beat
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

October 25, 2022

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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

Locations

TW(1)