REINVENT: A Brain and Muscle Computer Interface for Stroke

NCT ID: NCT06285175

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-02-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tele-REINVENT

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

Group Type: EXPERIMENTAL

Tele-REINVENT

Intervention Type: OTHER

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

Interventions

Tele-REINVENT

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Sook-Lei Liew

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

Other Identifiers

APP-22-04497

Identifier Type: -

Identifier Source: org_study_id