Neurostimulation Exosuit Augmented Training (NEAT) in the Clinic
Completed · Not applicable
Conditions studied: Stroke
In brief
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 training in progressively challenging environments for individuals in the chronic phase of stroke recovery. The investigators will monitor feasibility of the training program and assess walking endurance and energy efficiency before and after the training to quantify effects of the training program on the recovery of walking function driven by improvements in forward propulsion and symmetry between limbs. Participants will complete pre-training and post-training evaluations alongside 12 gait training sessions across 4-5 weeks.
Key facts
- Study ID
- NCT07218107
- Run by
- Boston University Charles River Campus
- People needed
- 4
- Starts
- 2024-06-04
- Expected to finish
- 2024-10-23
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Center for Neurorehabilitation — Boston, Massachusetts, United States
- Neuromotor Recovery Laboratory — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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