NCT03891641TerminatedNot Applicable
A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease
University of North Carolina, Chapel Hill2 sites in 1 country17 target enrollmentStarted: June 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Change in Overground Walking Speed After Intervention
Study Overview
Brief Summary
This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., "treadling") through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No Masking
Eligibility Criteria
- Ages
- 65 Years to 99 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be able to walk without an assistive aid (i.e., walker, cane)
- •Have the capacity the provide written informed consent
- •Have previously diagnosed peripheral arterial disease (by self-report)
Exclusion Criteria
- •Lower extremity injury or fracture within the last 6 months
- •Have a leg prosthesis
- •Prisoners
- •Individuals clearly lacking the capacity to provide informed consent
- •Vestibular impairment
Outcomes
Primary Outcomes
Change in Overground Walking Speed After Intervention
Time Frame: Baseline, 6 weeks
Measured from the time taken to walk 6 meters.
Change in 6-min Walk Distance
Time Frame: Baseline, 6 weeks
Measured from the distance walked in 6 minutes.
Secondary Outcomes
- Change in Stride Length(Baseline, 6 weeks)
- Change in Peak Ankle Power(Baseline, 6 weeks)
Investigators
Study Sites (2)
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