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StrokeNCT01962662

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

A study testing EMG biofeedback training and U/E exercise in people with Stroke and Feedback, Psychological, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke, Feedback, Psychological, Motor Deficit
What is being tested?
EMG biofeedback training and U/E exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTaiwan
Study dates
Jan 2012to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • stroke over three months
  • unilateral hemiplegia or hemiparesis
  • ankle movement deficit
  • independent standing over 20 seconds
  • independent walking over 10 meters
  • can follow order

Who cannot join

  • no parkinsonism, hip and knee arthroplasty
  • no acute L/E pain
  • no epilepsy history
  • no pacemaker
  • no metal device in head

Trial locations and contacts

1 site in 1 country.

Ming-Hsia Hu, PhD contact

886-2-33668137

mhh@ntu.edu.tw

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    +886-2-33668137, d95428004@ntu.edu

    Peih-Ling Tsaih, MS

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
EMG biofeedback training, U/E exercise
Keywords
stroke, transcranial magnetic stimulation, EMG biofeedback, motor function, neural plasticity, force
Medical subject headings
Stroke, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMG biofeedback trainingOther

    EMG biofeedback assisted tibialis anterial force level control

  • U/E exerciseOther

    strengthening and stretching

Study groups in NCT01962662
Study groupRoleWhat they receive
variable practiceExperimentalEMG biofeedback training on force control muscle the goal of force level control training is 25%, 50%, 75%, and 100% of maximal strength.
Receives: Other: EMG biofeedback training
constant practice groupExperimentalEMG biofeedback training on force control muscle the goal of force level control training is 100% of maximal strength.
Receives: Other: EMG biofeedback training
control groupOtherU/E exercise
Receives: Other: U/E exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tibialis Anterior muscle strength

    By hand-held dynamometer

    Measured: four years

Secondary outcomes (7)
  1. Tibialis Anterior muscle force control error

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

    Measured: four years

  2. walking speed

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

    Measured: four years

  3. Timed Up and Go Test

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

    Measured: four years

  4. 6 Minutes Walking Test

    The distance of walking within 6 minutes, unit: metres

    Measured: four years

  5. Ankle Range Of Motion

    degree, measure by goniometer

    Measured: four years

  6. Motor Evoke Potential threshold

    By Transcranial Magnetic Stimulation

    Measured: four years

  7. recruitment curve of Tibialis Anterior

    By Transcranial Magnetic Stimulation

    Measured: four years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2014 (estimated)
  4. Study completionJul 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01962662
Sponsor's protocol ID
201101080RB
Other IDs
NSC 100-2314-B-002 -152 -
Status last verified
Oct 2013
First submitted
30 Jan 2013
Last updated
14 Oct 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30598705

Questions about this trial

What is this clinical trial studying?

A study testing EMG biofeedback training and U/E exercise in people with Stroke and Feedback, Psychological, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ming-Hsia Hu, PhD (886-2-33668137, mhh@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tibialis Anterior muscle strength (time frame: four years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01962662, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.

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