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REINVENT: A Brain and Muscle Computer Interface for Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06285175
Acronym
REINVENT
Enrollment
14
Registered
2024-02-29
Start date
2021-06-01
Completion date
2024-02-15
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

OTHERTele-REINVENT

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

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Corticomuscular coherenceThrough study completion, an average of 1 monthThis assessment measures the connectivity between the brain and muscles of the affected side as a percentage.
Fugl Meyer Assessment - Upper ExtremityThrough study completion, an average of 1 monthThis assessment measures upper limb impairment after stroke
Maximum EMG activityThrough study completion, an average of 1 monthThis assessment measures trace muscle activity in the affected limb during a controlled movement task

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026