Status:
COMPLETED
Soleus Loading Response During Walking
Lead Sponsor:
Victor H. Duenas
Collaborating Sponsors:
Medical University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Healthy
Spastic Hemiparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Stroke survivors experience motor deficits, weak voluntary muscle activations, and low weight-bearing capacity that impair ambulation. Restoring motor function is a priority for people post-stroke, wh...
Detailed Description
Participants are assigned to a single group in this basic science study. The protocol includes testing a wearable powered ankle device and its control algorithm during treadmill walking. The robotic a...
Eligibility Criteria
Inclusion
- For able-bodied individuals, the inclusion criterion is adults with no known neurological conditions or history of orthopedic injuries.
- For individuals after stroke, inclusion criteria include participants who are neurologically stable for \>6 months (and \>1 year post stroke) and have medical clearance to participate in the study (with the expectation that current medication will be maintained without change for at least 4 months); ability to ambulate with or without an assistive device at least 10 m; and unilateral ankle extensor spasticity (hemiparesis); and able to wear the robotic ankle device, provide written informed consent and follow instructions.
Exclusion
- For able-bodied individuals, the exclusion criteria are motoneuron injury; a cardiac condition (history of myocardial infarct, pacemaker use); an unstable medical condition; and inability to provide written informed consent.
- For individuals after stroke, the exclusion criteria are are a cardiac condition (history of myocardial infarction or congestive heart failure, pacemaker use); motoneuron injury (i.e., the neurons that give rise to the axons innervating the muscles); ambulation velocity of \>1.2 m/s; a medically unstable condition (e.g., unstable angina, shortness of breath without exertion); musculoskeletal disorders that limit ambulation; and inability to provide informed consent.
Key Trial Info
Start Date :
September 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05436366
Start Date
September 30 2022
End Date
August 31 2024
Last Update
November 29 2024
Active Locations (1)
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1
Syracuse University
Syracuse, New York, United States, 13244