Intervention Study of EMG Biofeedback Assisted Force Control to Treat Stroke Movement Disorder
Primary Purpose
Stroke, Feedback, Psychological, Motor Deficit
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
EMG biofeedback training
U/E exercise
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, transcranial magnetic stimulation, EMG biofeedback, motor function, neural plasticity, force
Eligibility Criteria
Inclusion Criteria:
- stroke over three months
- unilateral hemiplegia or hemiparesis
- ankle movement deficit
- independent standing over 20 seconds
- independent walking over 10 meters
- can follow order
Exclusion Criteria:
- no parkinsonism, hip and knee arthroplasty
- no acute L/E pain
- no epilepsy history
- no pacemaker
- no metal device in head
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
variable practice
constant practice group
control group
Arm Description
EMG biofeedback training on force control muscle the goal of force level control training is 25%, 50%, 75%, and 100% of maximal strength.
EMG biofeedback training on force control muscle the goal of force level control training is 100% of maximal strength.
U/E exercise
Outcomes
Primary Outcome Measures
Tibialis Anterior muscle strength
By hand-held dynamometer
Secondary Outcome Measures
Tibialis Anterior muscle force control error
By hand-held dynamometer, unit: %(error trials/total trials)
walking speed
The time of middle 6 meters within 10 meters. unit: meter/minute
Timed Up and Go Test
The time of stand up and walking 3 meters and back to seat. unit: seconds
6 Minutes Walking Test
The distance of walking within 6 minutes, unit: metres
Ankle Range Of Motion
degree, measure by goniometer
Motor Evoke Potential threshold
By Transcranial Magnetic Stimulation
recruitment curve of Tibialis Anterior
By Transcranial Magnetic Stimulation
Full Information
NCT ID
NCT01962662
First Posted
January 30, 2013
Last Updated
October 10, 2013
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01962662
Brief Title
Intervention Study of EMG Biofeedback Assisted Force Control to Treat Stroke Movement Disorder
Official Title
Effects of Force Level Control Training Using EMG Biofeedback on Transcranial Magnetic Stimulation-Induced Excitability to Anterial Tibialis and Motor Functions After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Force generation and force level control are important neuromuscular control mechanism for successful execution of movement for our daily activities. Impaired force level control is a major deficit of motor control in people with stroke. Electromyographic biofeedback (EMG biofeedback) has been suggested by researchers and clinicians to be a useful and effective tool for enhancing control of force level during motor skill learning for people with stroke. Based on the concept of motor-skill learning, practice with variable force levels may be more effective than practice with a constant force level to enhance movement performance. The EMG biofeedback provides a suitable tool for such practice of force level control and hence for motor skill learning. However, research literatures thus far have yet to provide convincing evidences to support this claim. Neural imaging studies have shown corresponding brain reorganization and neural plasticity following physical practice of movement skills in people with stroke. It is curious whether EMG biofeedback augmented physical practice of motor skills enhances brain reorganization. Using brain mapping techniques, in particular, the transcranial magnetic stimulation (TMS), we could investigate neural plasticity accompanying motor function changes induced by physical training, and hence may help to develop safer and more effective training parameters. The purpose of this study is to examine the effects of variable practiced EMG biofeedback training emphasized on force level control of the ankle muscle on balance and gait performance and the corresponding changes of corticospinal excitability using TMS in people with chronic stroke.
Detailed Description
Background: Force generation and force level control are important neuromuscular control mechanism for successful execution of movement for our daily activities. Impaired force level control is a major deficit of motor control in people with stroke. Electromyographic biofeedback (EMG biofeedback) has been suggested by researchers and clinicians to be a useful and effective tool for enhancing control of force level during motor skill learning for people with stroke. Based on the concept of motor-skill learning, practice with variable force levels may be more effective than practice with a constant force level to enhance movement performance. The EMG biofeedback provides a suitable tool for such practice of force level control and hence for motor skill learning. However, research literatures thus far have yet to provide convincing evidences to support this claim. Neural imaging studies have shown corresponding brain reorganization and neural plasticity following physical practice of movement skills in people with stroke. It is curious whether EMG biofeedback augmented physical practice of motor skills enhances brain reorganization. Using brain mapping techniques, in particular, the transcranial magnetic stimulation (TMS), we could investigate neural plasticity accompanying motor function changes induced by physical training, and hence may help to develop safer and more effective training parameters. The purpose of this study is to examine the effects of variable practiced EMG biofeedback training emphasized on force level control of the ankle muscle on balance and gait performance and the corresponding changes of corticospinal excitability using TMS in people with chronic stroke. Study Design and Methods: This study is a single-blind randomized controlled trial. Sixty participants will be recruited and randomly assigned to one of the three groups: constant practice, variable practice and control group. Each participant receives 3 days per week for a total of 6 weeks of EMG biofeedback assisted force level control training of the Tibialis Anterior (TA) muscle. For the variable practice group, the participants will practice exertion of force output levels at 100%, 75%, 50%, and 25% of maximal TA muscle strength with EMG feedback. For the constant practice group, the goal of force level control training is 100% of maximal strength. The control group participants will practice maximal TA muscle control without EMG feedback. Balance and gait-related motor functions, such as TA force control error, TA strength, ankle range of motion, calf muscle spasticity, walking speed, Timed Up and Go test, Six-minute Walking test, and dynamic balance test and corticospinal excitability including threshold, latency, and recruitment curve of TA motor evoked (MEP) potentials will be evaluated at baseline, post-training, two weeks after training and six weeks after training. Statistical Package for Social Science (SPSS)13.0 will be used for statistical analysis. Anticipated results: We anticipate that all three groups of participants may demonstrate changes in maximal weight shift amplitude, gait speed and corticospinal excitability. However, only the variable practice group will demonstrate ability to modify and vary force level control during balance and gait tasks, and reveal corresponding changes in recruitment curve of TA MEP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Feedback, Psychological, Motor Deficit
Keywords
stroke, transcranial magnetic stimulation, EMG biofeedback, motor function, neural plasticity, force
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
variable practice
Arm Type
Experimental
Arm Description
EMG biofeedback training on force control muscle the goal of force level control training is 25%, 50%, 75%, and 100% of maximal strength.
Arm Title
constant practice group
Arm Type
Experimental
Arm Description
EMG biofeedback training on force control muscle the goal of force level control training is 100% of maximal strength.
Arm Title
control group
Arm Type
Other
Arm Description
U/E exercise
Intervention Type
Other
Intervention Name(s)
EMG biofeedback training
Intervention Description
EMG biofeedback assisted tibialis anterial force level control
Intervention Type
Other
Intervention Name(s)
U/E exercise
Intervention Description
strengthening and stretching
Primary Outcome Measure Information:
Title
Tibialis Anterior muscle strength
Description
By hand-held dynamometer
Time Frame
four years
Secondary Outcome Measure Information:
Title
Tibialis Anterior muscle force control error
Description
By hand-held dynamometer, unit: %(error trials/total trials)
Time Frame
four years
Title
walking speed
Description
The time of middle 6 meters within 10 meters. unit: meter/minute
Time Frame
four years
Title
Timed Up and Go Test
Description
The time of stand up and walking 3 meters and back to seat. unit: seconds
Time Frame
four years
Title
6 Minutes Walking Test
Description
The distance of walking within 6 minutes, unit: metres
Time Frame
four years
Title
Ankle Range Of Motion
Description
degree, measure by goniometer
Time Frame
four years
Title
Motor Evoke Potential threshold
Description
By Transcranial Magnetic Stimulation
Time Frame
four years
Title
recruitment curve of Tibialis Anterior
Description
By Transcranial Magnetic Stimulation
Time Frame
four years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stroke over three months
unilateral hemiplegia or hemiparesis
ankle movement deficit
independent standing over 20 seconds
independent walking over 10 meters
can follow order
Exclusion Criteria:
no parkinsonism, hip and knee arthroplasty
no acute L/E pain
no epilepsy history
no pacemaker
no metal device in head
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Hsia Hu, PhD
Phone
886-2-33668137
Email
mhh@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Hsia Hu, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei city
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+886-2-33668137
Email
d95428004@ntu.edu
First Name & Middle Initial & Last Name & Degree
Peih-Ling Tsaih, MS
12. IPD Sharing Statement
Citations:
PubMed Identifier
30598705
Citation
Tsaih PL, Chiu MJ, Luh JJ, Yang YR, Lin JJ, Hu MH. Practice Variability Combined with Task-Oriented Electromyographic Biofeedback Enhances Strength and Balance in People with Chronic Stroke. Behav Neurol. 2018 Nov 26;2018:7080218. doi: 10.1155/2018/7080218. eCollection 2018.
Results Reference
derived
Learn more about this trial
Intervention Study of EMG Biofeedback Assisted Force Control to Treat Stroke Movement Disorder
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