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NCT03891641 Clinical Trial

Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

Peripheral Arterial Disease Clinical Trial

Official title:
A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03891641
Other study ID # 18-3169
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date June 15, 2020

Study information
Verified date August 2020
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Treadwell Tredlr
Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.

Locations
Country Name City State
United States Applied Biomechanics Laboratory Chapel Hill North Carolina

Sponsors (2)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Treadwell Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Overground Walking Speed After Intervention Measured from the time taken to walk 6 meters. Baseline, 6 weeks
Primary Change in 6-min Walk Distance Measured from the distance walked in 6 minutes. Baseline, 6 weeks
Secondary Change in Stride Length Measured using motion capture as the distance between heel markers across successive steps. Baseline, 6 weeks
Secondary Change in Peak Ankle Power Measured using motion capture and instrumented treadmill forces as the peak positive power generated by the calf muscles during the push-off phase of walking. Baseline, 6 weeks
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