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Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891641
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Behavioral: Treadwell Tredlr Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Treatment
Official Title: A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treadling Group
Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
Behavioral: Treadwell Tredlr
Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.

No Intervention: Control Group
Control Subjects continue their normal daily activities.



Primary Outcome Measures :
  1. Change in Overground Walking Speed After Intervention [ Time Frame: Baseline, 6 weeks ]
    Measured from the time taken to walk 6 meters.

  2. Change in 6-min Walk Distance [ Time Frame: Baseline, 6 weeks ]
    Measured from the distance walked in 6 minutes.


Secondary Outcome Measures :
  1. Change in Stride Length [ Time Frame: Baseline, 6 weeks ]
    Measured using motion capture as the distance between heel markers across successive steps.

  2. Change in Peak Ankle Power [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 99 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891641


Contacts
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Contact: Jason Franz, PhD (919) 966-6119 jrfranz@email.unc.edu

Locations
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United States, North Carolina
Applied Biomechanics Laboratory Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Jason Franz, Ph.D.    919-966-6119    jrfranz@email.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Jason Franz, PhD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03891641    
Other Study ID Numbers: 18-3169
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases