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.
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.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
+886-2-33668137, d95428004@ntu.edu
Peih-Ling Tsaih, MS
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.
- Conditions
- Stroke, Feedback, Psychological, Motor Deficit
- 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 group | Role | What they receive |
|---|---|---|
| variable practice | Experimental | EMG 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 group | Experimental | EMG biofeedback training on force control muscle the goal of force level control training is 100% of maximal strength. Receives: Other: EMG biofeedback training |
| control group | Other | U/E exercise Receives: Other: U/E exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibialis Anterior muscle strength
By hand-held dynamometer
Measured: four years
Secondary outcomes (7)
Tibialis Anterior muscle force control error
By hand-held dynamometer, unit: %(error trials/total trials)
Measured: four years
walking speed
The time of middle 6 meters within 10 meters. unit: meter/minute
Measured: four years
Timed Up and Go Test
The time of stand up and walking 3 meters and back to seat. unit: seconds
Measured: four years
6 Minutes Walking Test
The distance of walking within 6 minutes, unit: metres
Measured: four years
Ankle Range Of Motion
degree, measure by goniometer
Measured: four years
Motor Evoke Potential threshold
By Transcranial Magnetic Stimulation
Measured: four years
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.
- First posted14 Oct 2013 (estimated)
- Study startJan 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Hsia Hu, PhD, Principal investigator, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01962662
- Acronym / sponsor ID
- 201101080RB
- Conditions
- Stroke, Feedback, Psychological, Motor Deficit
- Keywords
- stroke, transcranial magnetic stimulation, EMG biofeedback, motor function, neural plasticity, force
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| variable practice | Experimental | Other: EMG biofeedback trainingEMG biofeedback training on force control muscle the goal of force level control training is 25%, 50%, 75%, and 100% of maximal strength. |
| constant practice group | Experimental | Other: EMG biofeedback trainingEMG biofeedback training on force control muscle the goal of force level control training is 100% of maximal strength. |
| control group | Other | Other: U/E exerciseU/E exercise |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- stroke over three months
- unilateral hemiplegia or hemiparesis
- ankle movement deficit
- independent standing over 20 seconds
- independent walking over 10 meters
Key exclusion criteria (5 listed)
- no parkinsonism, hip and knee arthroplasty
- no acute L/E pain
- no epilepsy history
- no pacemaker
- no metal device in head
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG biofeedback trainingEMG biofeedback assisted tibialis anterial force level control | Other | constant practice group, variable practice |
| U/E exercisestrengthening and stretching | Other | control group |
Primary outcome
Tibialis Anterior muscle strength
Time frame: four years
By hand-held dynamometer
7 secondary outcomes
Tibialis Anterior muscle force control error
Time frame: four years
walking speed
Time frame: four years
Timed Up and Go Test
Time frame: four years
6 Minutes Walking Test
Time frame: four years
Ankle Range Of Motion
Time frame: four years
Motor Evoke Potential threshold
Time frame: four years
recruitment curve of Tibialis Anterior
Time frame: four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
- Derived from this study: PubMed 30598705Tsaih 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.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Hsia Hu, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
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.