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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011018
• Other study ID #: KMUHIRB-F(II)-20220175
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: August 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: LIN JAU HONG, Ph.D.
• Phone: 0929393300
• Email: jhlin[@]kmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults
• Stroke

Intervention

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
• 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.
• Mirror Therapy + Binaural Beat
Same as the mirror therapy protocol. Listen to music (mozart's clarinex concerto in A major K622), with Alpha (8Hz) binaural beat stimulation

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University, Department of Physical Therapy	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	20minutes
Primary	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	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.	5minutes
Secondary	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.	5minutes
Secondary	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.	10 minutes
Secondary	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.	5minutes