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NCT07164846NARecruiting

Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait

Brooks Rehabilitation

Start Date

8/5/2025

Completion Date

8/1/2026

Summary

This research aims to understand the effect of the Neuro20 Functional Electrical Stimulation Suit on autonomic nervous system function, muscle performance, and gait after amputation or neurologic injury.

Detailed Description

The purpose of this research study is to study the effect of the Neuro20 Functional Electrical Stimulation Suit on autonomic function, muscle performance, and walking ability. Electrical stimulation is intended to stimulate muscles in order to improve muscle performance. The Neuro20 is approved for this use by the United States Food and Drug Administration. In this study, the use of the device is considered investigational. Twenty subjects will participate in this study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * At least one week post amputation or neurologic injury (i.e. brain injury, stroke, spinal cord injury) and deemed medically stable to participate in rehabilitation * Able to provide Informed Consent by demonstrating the ability to follow a three step command Exclusion Criteria: * Pacemaker / Defibrillator or severe cardiac disease (Class IV according to New York Heart Association Functional Classification) * Implanted medical devices * Active DVT/thrombophlebitis * Active Cancer * Active fever, infection, or acute inflammation * Pregnancy * Epilepsy or uncontrolled seizures or seizure within the last 6 months * Implanted stimulator or pump that cannot be turned off externally * Significant, active wounds in areas stimulated by the suit * Inability to follow a three-step motor command * Bleeding tendency

Interventions

DEVICE

Therapy Sessions

Interested in This Trial?

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Conditions

Spinal Cord InjuryStrokeAmputees

Locations

Brooks Rehabilitation

Jacksonville, Florida 32216

United States

The International Institute of Orthotics and Prosthetics

Tampa, Florida 33634

United States