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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Suit Stimulation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Grimes | Contact | 904-597-3478 | hannah.grimes@brooksrehab.org |
| Name | Affiliation | Role |
|---|---|---|
| Mark Bowden, PT, PhD | Brooks Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooks Rehabilitation | Recruiting | Jacksonville | Florida | 32216 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| The International Institute of Orthotics and Prosthetics | Not yet recruiting | Tampa | Florida | 33634 | United States |
|
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |