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Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

NCT ID: NCT03891641

Last Updated: 2020-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-06-15

Brief Summary

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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

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No Masking

Study Groups

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Treadling Group

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

Group Type EXPERIMENTAL

Treadwell Tredlr

Intervention Type BEHAVIORAL

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

Control Group

Control Subjects continue their normal daily activities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Treadwell Tredlr

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Treadwell Therapeutics, Inc

INDUSTRY

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Franz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Applied Biomechanics Laboratory

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-3169

Identifier Type: -

Identifier Source: org_study_id