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Recruiting NCT06011018

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

No phase Interventional Stroke Healthy Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mirror Therapy, Mirror Therapy + Electrical Stimulation, Mirror Therapy + Binaural Beat.
Who it may be relevant to
Registry conditions: Stroke, Healthy Adults. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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
  • 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.
  • Other Mirror Therapy + Binaural Beat
    Same as the mirror therapy protocol. Listen to music (pink noise), with 14Hz binaural beat stimulation

Primary outcome measures

  • Fugl-Meyer assessment, lower extremity [Time frame: 10minutes]
Secondary outcome measures (4)
  • Modified ashworth scale [Time frame: 5minutes]
  • Timed up and go test [Time frame: 5minutes]
  • The postural assessment scale for stroke patients [Time frame: 10 minutes]
  • Barthel index [Time frame: 5minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Kaohsiung Medical University, Department of Physical Therapy — Kaohsiung City

Identifiers

NCT: NCT06011018 · KMUHIRB-F(II)-20220175

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗