Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrooks Rehabilitation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pacemaker / Defibrillator or severe cardiac disease (Class IV according to New York Heart Association Functional Classification)
Implanted medical devices
Active DVT/thrombophlebitis
Active Cancer
Trial design
Design model
Single group
Treatments tested in this trial
Therapy Sessions
DeviceYou will complete up to 12 sessions using the Neuro20 suit under the direct supervision of study staff. Each session will be 1-2 hours in duration. Each session, you will change into the suit and then receive no more than 105 minutes of electrical stimulation, and then change out of the suit and have a skin check. The suit has 20 electrodes that will stimulate muscles in your upper arm (above the elbow), upper leg (above the knee), chest, abdominals, and back. Stimulation levels will be adjusted to your comfort. You will likely feel tingling and/or muscle contractions. The timing and intensity of each type of activity will depend on your individual needs and will be prescribed by the study doctor.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Active Suit StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gait
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.
Time frame
Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeksSecondary outcomes
1
Change in Autonomic Function
Heart rate variability measures the variation in time between individual heartbeats, not just the average heart rate. An increase in variabiility indicates better health.
Time frame
Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov