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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Brooks Rehabilitation
Study ID
NCT07164846
Status
Recruiting
Apply to this trial

Conditions

  • Amputees
  • Spinal Cord Injury
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Therapy Sessions — DEVICE
    You 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.

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
Oct 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Change in Gait [ Time Frame: Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brooks RehabilitationJacksonvilleFlorida32216
Hannah Grimes
[email protected]
904-528-3159
Mark Bowden (PRINCIPAL_INVESTIGATOR)
The International Institute of Orthotics and ProstheticsTampaFlorida33634
Mike Hoggatt
[email protected]
601-720-7291
Arlene Gillis (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

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By research site
Brooks Rehabilitation· Jacksonville, FLThe International Institute of Orthotics and Prosthetics· Tampa, FL

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