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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

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

Study details
    Spinal Cord Injury
    Stroke
    Amputees

NCT07164846

Brooks Rehabilitation

1 November 2025

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