Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Brooks Rehabilitation
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change in Gait
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active Suit Stimulation
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.
Intervention: Therapy Sessions (Device)
Outcomes
Primary Outcomes
Change in Gait
Time Frame: 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 Outcomes
- Change in Autonomic Function(Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks)
Investigators
mark.bowden
Vice President of Clinical Integration and Research
Brooks Rehabilitation