Intervention Study of EMG Biofeedback Assisted Force Control to Treat Stroke Movement Disorder

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01962662
• Other study ID #: 201101080RB
• Secondary ID: NSC 100-2314-B-0
• Status: Recruiting
• Phase: N/A
• First received: January 30, 2013
• Last updated: October 10, 2013
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: Ming-Hsia Hu, PhD
• Phone: 886-2-33668137
• Email: mhh[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Feedback, Psychological
• Motor Deficit
• Stroke

Intervention

Other:
• EMG biofeedback training
EMG biofeedback assisted tibialis anterial force level control
• U/E exercise
strengthening and stretching

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tibialis Anterior muscle strength	By hand-held dynamometer	four years	No
Secondary	Tibialis Anterior muscle force control error	By hand-held dynamometer, unit: %(error trials/total trials)	four years	No
Secondary	walking speed	The time of middle 6 meters within 10 meters. unit: meter/minute	four years	No
Secondary	Timed Up and Go Test	The time of stand up and walking 3 meters and back to seat. unit: seconds	four years	No
Secondary	6 Minutes Walking Test	The distance of walking within 6 minutes, unit: metres	four years	No
Secondary	Ankle Range Of Motion	degree, measure by goniometer	four years	No
Secondary	Motor Evoke Potential threshold	By Transcranial Magnetic Stimulation	four years	No
Secondary	recruitment curve of Tibialis Anterior	By Transcranial Magnetic Stimulation	four years	No