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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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