Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
Completed · Not applicable
Conditions studied: Stroke
In brief
This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.
Key facts
- Study ID
- NCT06459401
- Run by
- Boston University Charles River Campus
- People needed
- 10
- Starts
- 2021-02-22
- Expected to finish
- 2022-05-17
- 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…
- Diagnosis of a stroke event occurring at least 6 months ago
- Observable gait deficits
- Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended
- Ability to follow a 3-step command
- Resting heart rate between 40-100 bpm
- Resting blood pressure between 90/60 and 170/90 mmHg
- NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
- HIPAA Authorization to allow communication with healthcare provider
- Medical clearance by a physician
You may not qualify if…
- Severe aphasia or inability to communicate with investigators
- Neglect or hemianopia
- Serious comorbidities that may interfere with ability to participate in the research (e.g. musculoskeletal, cardiovascular, pulmonary)
- Pacemakers or similar electrical implants that could be affected by electrical stimulation
- Metal implants directly under the stimulation sites
- Pressure ulcers or skin wounds located near human-device interface sites
- More than 2 unexplained falls in the previous month
Where it is running
- Science and Engineering Complex — Boston, Massachusetts, United States
- Neuromotor Recovery Laboratory — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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