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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

First occurrence of stroke≧ 6 months

Mini-mental state examination≧24

Modified Ashworth's scale of ankle muscle ≦3

Sit independently≧30 mins

Disqualifiers

Speech impairment

Hearing impairment

Visual impairment

Other orthopedic diseases or nerve damage

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirror Therapy

    Other intervention

    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 intervention

    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 intervention

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

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: Mirror therapyExperimental treatment 1 intervention
Group B: Mirror Therapy + Electrical StimulationExperimental treatment 1 intervention
Group C: Mirror Therapy + Binaural BeatExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
10minutes

Secondary outcomes

1

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.

Time frame
5minutes
2

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.

Time frame
5minutes
3

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.

Time frame
10 minutes
4

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.

Time frame
5minutes

Other outcomes

1

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).

Time frame
20minutes

Sponsors and contacts

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