REINVENT: A Brain and Muscle Computer Interface for Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Tele-REINVENT

• Registration Number: NCT06285175
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-09-28
• Primary Completion: 2023-12-15
• Status Verified: 2024-02
• Study Completion: 2024-02-15
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tele-REINVENT	Tele-REINVENT	All participants in this study are asked to use tele-REINVENT, a 6 week home tele-rehab program with EMG biofeedback.

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Assessment - Upper Extremity	Through study completion, an average of 1 month	This assessment measures upper limb impairment after stroke
Corticomuscular coherence	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	Through study completion, an average of 1 month	This assessment measures trace muscle activity in the affected limb during a controlled movement task

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States