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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01962662
Collaborator
(none)
100
1
3
30
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: EMG biofeedback training
  • Other: U/E exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Jul 1, 2014
Anticipated Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: variable practice

EMG biofeedback training on force control muscle the goal of force level control training is 25%, 50%, 75%, and 100% of maximal strength.

Other: EMG biofeedback training
EMG biofeedback assisted tibialis anterial force level control

Experimental: constant practice group

EMG biofeedback training on force control muscle the goal of force level control training is 100% of maximal strength.

Other: EMG biofeedback training
EMG biofeedback assisted tibialis anterial force level control

Other: control group

U/E exercise

Other: U/E exercise
strengthening and stretching

Outcome Measures

Primary Outcome Measures

  1. Tibialis Anterior muscle strength [four years]

    By hand-held dynamometer

Secondary Outcome Measures

  1. Tibialis Anterior muscle force control error [four years]

    By hand-held dynamometer, unit: %(error trials/total trials)

  2. walking speed [four years]

    The time of middle 6 meters within 10 meters. unit: meter/minute

  3. Timed Up and Go Test [four years]

    The time of stand up and walking 3 meters and back to seat. unit: seconds

  4. 6 Minutes Walking Test [four years]

    The distance of walking within 6 minutes, unit: metres

  5. Ankle Range Of Motion [four years]

    degree, measure by goniometer

  6. Motor Evoke Potential threshold [four years]

    By Transcranial Magnetic Stimulation

  7. recruitment curve of Tibialis Anterior [four years]

    By Transcranial Magnetic Stimulation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei city Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Ming-Hsia Hu, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01962662
Other Study ID Numbers:
  • 201101080RB
  • NSC 100-2314-B-002 -152 -
First Posted:
Oct 14, 2013
Last Update Posted:
Oct 14, 2013
Last Verified:
Oct 1, 2013
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2013