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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Syracuse University

Syracuse, New York, United States, 13244