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

Not Applicable

Recruiting

• Conditions: Amputees; Spinal Cord Injury; Stroke

• Registration Number: NCT07164846
• Lead Sponsor: Brooks Rehabilitation

Brief 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.

Study Timeline

• Study Start: 2025-08-05
• Study First Submitted: 2025-08-07
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Gait	Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks	The 6-minute walk test is a simple, standardized test used to assess a person's exercise capacity and functional mobility. An increase in distance walked reflects an improvement in mobility and gait.

Secondary Outcome Measures

Name	Time	Method
Change in Autonomic Function	Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks	Heart rate variability measures the variation in time between individual heartbeats, not just the average heart rate. An increase in variabiility indicates better health.

Trial Locations

Locations (2)

Brooks Rehabilitation; 🇺🇸 Jacksonville, Florida, United States

The International Institute of Orthotics and Prosthetics; 🇺🇸 Tampa, Florida, United States