Back to resultsMomentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility
Primary Purpose
Peripheral Arterial Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treadwell Tredlr
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
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
Sites / Locations
- Applied Biomechanics Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treadling Group
Control Group
Arm Description
Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
Control Subjects continue their normal daily activities.
Outcomes
Primary Outcome Measures
Change in Overground Walking Speed After Intervention
Measured from the time taken to walk 6 meters.
Change in 6-min Walk Distance
Measured from the distance walked in 6 minutes.
Secondary Outcome Measures
Change in Stride Length
Measured using motion capture as the distance between heel markers across successive steps.
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.
Full Information
NCT ID
NCT03891641
First Posted
March 25, 2019
Last Updated
October 9, 2020
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Treadwell Therapeutics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03891641
Brief Title
Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility
Official Title
A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 continues to prevent recruitment of people over the age of 65 years.
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Treadwell Therapeutics, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
No Masking
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treadling Group
Arm Type
Experimental
Arm Description
Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Subjects continue their normal daily activities.
Intervention Type
Behavioral
Intervention Name(s)
Treadwell Tredlr
Intervention Description
Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.
Primary Outcome Measure Information:
Title
Change in Overground Walking Speed After Intervention
Description
Measured from the time taken to walk 6 meters.
Time Frame
Baseline, 6 weeks
Title
Change in 6-min Walk Distance
Description
Measured from the distance walked in 6 minutes.
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Change in Stride Length
Description
Measured using motion capture as the distance between heel markers across successive steps.
Time Frame
Baseline, 6 weeks
Title
Change in Peak Ankle Power
Description
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.
Time Frame
Baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Franz, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Biomechanics Laboratory
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
IPD Sharing Time Frame
Beginning 9 to 36 months following publication.
IPD Sharing 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.
Learn more about this trial
Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility
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