Status:
COMPLETED
Neurostimulation Exosuit Augmented Training (NEAT) in the Clinic
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
Harvard University
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary goal of this study is to understand the feasibility and rehabilitative effects of a Neurostimulation Exosuit Augmented Training (NEAT) program designed to provide high-intensity gait train...
Detailed Description
Functional electrical stimulation (FES) is commonly used to manage foot drop in people with post-stroke hemiparesis. Emerging use of FES applied to the paretic plantarflexors to facilitate push-off ab...
Eligibility Criteria
Inclusion
- Age 18 - 80 years old
- History of stroke event occurring at least 6 months ago
- Observable gait deficits characteristic of post-stroke hemiparesis
- Independent ambulation for at least 30 meters (with an assistive device if needed but without a rigid brace for the ankle)
- Ankle dorsiflexion range of motion at least to neutral (i.e., 90 degrees between the shank and the foot)
- Resting heart rate between 40 - 100 bpm (inclusive)
- Resting blood pressure between 90/60 and 170/90 mmHg (inclusive)
- HIPAA authorization to allow communication with healthcare provider as needed during the study period
- Medical clearance by a physician
Exclusion
- NIH Stroke Scale Question 1b score \> 1 and Question 1c score \> 0
- Inability to communicate with investigators
- Visual neglect or hemianopia
- History of cerebellar stroke
- Actively receiving physical therapy for walking
- More than 2 unexplained falls in the previous month
- Pressure ulcers or skin wounds located near human-device interface sites
- Pacemakers or similar electrical implants that could be affected by electrical stimulation
- Metal implants directly under the stimulation sites
- Skin allergy or other condition sensitive to the adhesive from transcutaneous neurostimulation electrode pads
- Other medical, orthopedic, and neurological conditions that prevent full participation in the research
Key Trial Info
Start Date :
June 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT07218107
Start Date
June 4 2024
End Date
October 23 2024
Last Update
October 17 2025
Active Locations (2)
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1
Center for Neurorehabilitation
Boston, Massachusetts, United States, 02215
2
Neuromotor Recovery Laboratory
Boston, Massachusetts, United States, 02215