Amputees, Spinal Cord Injury, Stroke
Conditions
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.
Interventions
DEVICETherapy Sessions
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.
Sponsors
Brooks Rehabilitation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactHannah Grimes
Outcome results
None listed