REINVENT: A Brain and Muscle Computer Interface for Stroke

NCT06285175 | Completed

• 1 other identifier: APP-22-04497
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Fugl Meyer Assessment - Upper Extremity

  This assessment measures upper limb impairment after stroke

  Through study completion, an average of 1 month

• Maximum EMG activity

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

  Through study completion, an average of 1 month

• Corticomuscular coherence

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

  Through study completion, an average of 1 month

Study Arms (1)

Tele-REINVENT

EXPERIMENTAL

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

Other: Tele-REINVENT

Interventions

Tele-REINVENT OTHER

Tele-REINVENT consists of EMG-biofeedback of the affected arm to control games on a computer screen.

Tele-REINVENT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: February 29, 2024
• Study Start: June 1, 2021
• Primary Completion: December 15, 2023
• Study Completion: February 15, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)