Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

Not Applicable

Terminated

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT03891641
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Study Start: 2019-06-01
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Status Verified: 2020-08
• Results First Submitted: 2020-10-09
• Results First Submitted QC: 2020-10-09
• Last Update Submitted: 2020-10-09
• Results First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Overground Walking Speed After Intervention	Baseline, 6 weeks	Measured from the time taken to walk 6 meters.
Change in 6-min Walk Distance	Baseline, 6 weeks	Measured from the distance walked in 6 minutes.

Secondary Outcome Measures

Name	Time	Method
Change in Stride Length	Baseline, 6 weeks	Measured using motion capture as the distance between heel markers across successive steps.
Change in Peak Ankle Power	Baseline, 6 weeks	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.

Trial Locations

Locations (1)

Applied Biomechanics Laboratory; 🇺🇸 Chapel Hill, North Carolina, United States