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

NCT01962662 | Unknown DMC

• 2 other identifiers: 201101080RBNSC 100-2314-B-002 -152 -
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Feedback, Psychological; Motor Deficit

Keywords

stroke; transcranial magnetic stimulation; EMG biofeedback; motor function; neural plasticity; force

Outcome Measures

Primary Outcomes (1)

• Tibialis Anterior muscle strength

  By hand-held dynamometer

  four years

Secondary Outcomes (7)

• Tibialis Anterior muscle force control error

  four years

• walking speed

  four years

• Timed Up and Go Test

  four years

• 6 Minutes Walking Test

  four years

• Ankle Range Of Motion

  four years

Study Arms (3)

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.

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.

Other: EMG biofeedback training

control group

OTHER

U/E exercise

Other: U/E exercise

Interventions

EMG biofeedback training OTHER

EMG biofeedback assisted tibialis anterial force level control

constant practice group; variable practice

U/E exercise OTHER

strengthening and stretching

control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 30598705 DERIVED

MeSH Terms

Conditions

Stroke; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming-Hsia Hu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Hsia Hu, PhD

CONTACT

886-2-33668137; mhh@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: October 14, 2013
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

TW (1)