Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

NCT03891641 | Terminated Results

• 1 other identifier: 18-3169
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Change in Overground Walking Speed After Intervention

  Measured from the time taken to walk 6 meters.

  Baseline, 6 weeks

• Change in 6-min Walk Distance

  Measured from the distance walked in 6 minutes.

  Baseline, 6 weeks

Secondary Outcomes (2)

• Change in Stride Length

  Baseline, 6 weeks

• Change in Peak Ankle Power

  Baseline, 6 weeks

Study Arms (2)

Treadling Group

EXPERIMENTAL

Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.

Behavioral: Treadwell Tredlr

Control Group

NO INTERVENTION

Control Subjects continue their normal daily activities.

Interventions

Treadwell Tredlr BEHAVIORAL

Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.

Treadling Group

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Treadwell Therapeutics, Inc: collaborator

Study Sites (1)

Applied Biomechanics Laboratory

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Jason R Franz, PhD
• Organization: University of North Carolina at Chapel Hill

jrfranz@email.unc.edu

919-966-6119

Study Officials

• Jason Franz, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized into a treadling group (n=15) or a control group (n=15). Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. The control group will be instructed to continue their normal daily activities.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: June 1, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: November 2, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 to 36 months following publication.
• Access Criteria: The investigator who proposes to use the data must have approval from an IRB, IEC, or REB, as applicable, and execute a data use/sharing agreement with the University of North Carolina at Chapel Hill.

Locations

US (1)