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NCT Number: 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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirror Therapy

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

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

Other

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

Primary outcomes

  1. Fugl-Meyer assessment, lower extremity

    Time frame: 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 outcomes

  1. Modified ashworth scale

    Time frame: 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.

  2. Timed up and go test

    Time frame: 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.

  3. The postural assessment scale for stroke patients

    Time frame: 10 minutes

    Higher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke.

  4. Barthel index

    Time frame: 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.

Other outcomes

  1. Electroencephalography

    Time frame: 20minutes

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

LIN JAU HONG, Ph.D.

CONTACT

[email protected]

0929393300

LIN YEN YU, Master's degree

CONTACT

[email protected]

0988392631

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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