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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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06011018
Enrollment
72
Registered
2023-08-25
Start date
2022-10-25
Completion date
2026-07-31
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults, Stroke

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.

Interventions

OTHERMirror 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

OTHERMirror 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.

OTHERMirror Therapy + Binaural Beat

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

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Participants were randomly assigned treatment groups: 1. Mirror Therapy 2. Mirror Therapy + Electrical Stimulation 3. Mirror Therapy + Binaural Beat

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer assessment, lower extremity10minutesThe 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

MeasureTime frameDescription
Modified ashworth scale5minutesThe 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.
Timed up and go test5minutesThe 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.
The postural assessment scale for stroke patients10 minutesHigher scores on the Postural Assessment Scale for Stroke Patients (PASS) indicate greater difficulty in postural control and stability after a stroke.
Barthel index5minutesThe 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

MeasureTime frameDescription
Electroencephalography20minutesElectroencephalography 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).

Countries

Taiwan

Contacts

Primary ContactLIN JAU HONG, Ph.D.
jhlin@kmu.edu.tw0929393300
Backup ContactLIN YEN YU, Master's degree
yenyu.lin88@yahoo.com0988392631

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026