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

Brooks Rehabilitation

Status: Enrolling

Conditions: Stroke; Amputees; Spinal Cord Injury

Treatments: Device: Therapy Sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT07164846

Pro00083882

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Active Suit Stimulation

Experimental group

Description:

Participants will be engaging in one hour of therapy with the suit in stimulation mode for twelve sessions. The first three sessions will be in conditioning mode, and the subsequent nine will be in strength mode.

Treatment:

Device: Therapy Sessions