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REINVENT: A Brain and Muscle Computer Interface for Stroke

NCT ID: NCT06285175

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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Tele-REINVENT

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

Intervention Type OTHER

Eligibility Criteria

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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

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Sook-Lei Liew

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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APP-22-04497

Identifier Type: -

Identifier Source: org_study_id