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Clinical Trials/NCT06285175
NCT06285175
Completed
Not Applicable

REINVENT: A Brain and Muscle Computer Interface for People With Severe Stroke

University of Southern California1 site in 1 country14 target enrollmentJune 1, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Southern California
Enrollment
14
Locations
1
Primary Endpoint
Fugl Meyer Assessment - Upper Extremity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
February 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sook-Lei Liew

Associate Professor

University of Southern California

Eligibility Criteria

Inclusion Criteria

  • Moderate to severe upper extremity hemiparesis and residual hand function (e.g., less than 20 degrees of active wrist or finger extension and enough muscle activity to measure with electromyography).

Exclusion Criteria

  • Taking anti-spasticity medication
  • Significant vision loss (corrected vision is acceptable)
  • Receptive aphasia
  • Hand contractures
  • Secondary neurological disease

Outcomes

Primary Outcomes

Fugl Meyer Assessment - Upper Extremity

Time Frame: Through study completion, an average of 1 month

This assessment measures upper limb impairment after stroke

Corticomuscular coherence

Time Frame: Through study completion, an average of 1 month

This assessment measures the connectivity between the brain and muscles of the affected side as a percentage.

Maximum EMG activity

Time Frame: Through study completion, an average of 1 month

This assessment measures trace muscle activity in the affected limb during a controlled movement task

Study Sites (1)

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