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Mechanics-based Intervention to Improve Post-stroke Stability

June 19, 2019

Overview

Every year, about 15,000 American Veterans suffer from a stroke. After a stroke the ability to walk is a top goal among victims. However, only half are able to return to normal mobility. This clinical trial will test a novel elastic force-field designed to improve post-stroke stability through targeted motor learning. The results of the experiment will serve as the basis for the development of novel gait rehabilitation techniques. This can lead to an increase in the quality of life of thousands of Veterans and save millions of dollars.

 

Study Information

This is an interventional, doube-blind, parallel assignment with the primary purpose of treatment. There is an estimated 54 participants. The study began on April 1, 2017, and is estimated to be completed by March 31, 2021.

 

Inclusion Criteria

 

  • All sexes, at least 21 years old
  • Experienced a stroke 6 months prior to participation
  • Preferred overground gait speed of at least 0.2 m/s
  • Ability to walk at self-selected speed for 3 minutes without a cane or walker
  • Able to provide informed consent

 

Exclusion Criteria

 

  • Resting heart rate above 110 beats/min
  • Resting blood pressure higher than 200/110 mm Hg
  • History of :
    • congestive heart failure
    • unstable cardiac arrhythmias
    • hypertrophic cardiomyopathy
    • severe aortic stenosis
    • angina or
    • dyspnea at rest or during activities of daily living
  • Pre Existing neurological disorders or dementia
  • History of major head trauma
  • Legal blindness or severe visual impairment
  • Life expectancy less than 1 year
  • History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  • Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern

 

Location

You may participate in this study at the Ralph H. Johnson VA Medical Center in Charleston, SC, United States, 294001-5799. If you have any questions or concerns please contact Jesse C Dean, PhD at 843-792-9566 or at deaje@musc.edu.

 

Sponsors/Collaborators

This clinical trial is being sponsored by the VA Office of Research and Development with Jesse C. Dean, PhD of the Ralph H. Johnson VA Medical Center in Charleston, SC as the Principal Investigator.

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