Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

University of North Carolina (UNC)

Status: Terminated

Conditions: Peripheral Arterial Disease

Treatments: Behavioral: Treadwell Tredlr

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03891641

18-3169

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 65 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Treadling Group

Experimental group

Description:

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

Treatment:

Behavioral: Treadwell Tredlr

Control Group

No Intervention group

Description:

Control Subjects continue their normal daily activities.