Back to resultsComparison 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
Primary Purpose
Stroke, Healthy Adults
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mirror Therapy
Mirror Therapy + Electrical Stimulation
Mirror Therapy + Binaural Beat
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
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
Sites / Locations
- Kaohsiung Medical University, Department of Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Mirror therapy
Mirror Therapy + Electrical Stimulation
Mirror Therapy + Binaural Beat
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT06011018
First Posted
August 21, 2023
Last Updated
August 27, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06011018
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Healthy Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned treatment groups:
Mirror Therapy
Mirror Therapy + Electrical Stimulation
Mirror Therapy + Binaural Beat
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mirror therapy
Arm Type
Experimental
Arm Title
Mirror Therapy + Electrical Stimulation
Arm Type
Experimental
Arm Title
Mirror Therapy + Binaural Beat
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Mirror Therapy + Electrical Stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy + Binaural Beat
Intervention Description
Same as the mirror therapy protocol. Listen to music (mozart's clarinex concerto in A major K622), with Alpha (8Hz) binaural beat stimulation
Primary Outcome Measure Information:
Title
Fugl-Meyer assessment, lower extremity
Description
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 Outcome Measure Information:
Title
Modified ashworth scale
Description
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
Title
Timed up and go test
Description
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
Title
The postural assessment scale for stroke patients
Description
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
Title
Barthel index
Description
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 Pre-specified Outcome Measures:
Title
Electroencephalography
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LIN JAU HONG, Ph.D.
Phone
0929393300
Email
jhlin@kmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
LIN YEN YU, Master's degree
Phone
0988392631
Email
yenyu.lin88@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LIN JAU HONG, Ph.D.
Organizational Affiliation
Kaohsiung Medical University,department of Physical Therapy
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Medical University, Department of Physical Therapy
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIN JAU HONG, Ph.D.
Phone
0929393300
Email
jhlin@kmu.edu.tw
First Name & Middle Initial & Last Name & Degree
LIN YEN YU, Master's
Phone
0988392631
Email
yenyu.lin88@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
During the study period, to ensure subject privacy, only the implementers of this research project, monitors, regulatory authorities, and the institutional review board of our institution have the authority to access the data
Learn more about this trial
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
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