Exoskeleton Footwear to Improve Walking

NCT04337554 | Completed FDA Device

• 1 other identifier: A3266-R
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the best assistance level of an exoskeleton footwear (EF) that can assist walking for people older than 40 with and without peripheral artery disease (PAD). The test will be performed on two different groups of people for this study that include: 1) people with PAD, and 2) individuals who don't have PAD. Data will be collected from 50 healthy older individuals and 25 patients with PAD, both groups will be 40 years or older. Gait biomechanics, muscle oxygenation, and energy cost for seven different walking conditions including normal walking, walking with EF with no assistance, and walking with EF with 5 different levels of assistance will be collected from the healthy older individuals. Additionally, subject-reported outcomes after each walking conditions including perceived comfort and fatigue, rate of perceived exertion and feasibility of the EF will be collected. Gait biomechanics, muscle oxygenation, energy cost, and patient-reported outcomes will be measured in patients with PAD for four walking conditions including normal walking, walking with EF but no assistance, walking with EF with the best two assistance levels. Subjects will be allowed to acclimate to the EF prior to recording data. All patients with PAD will participate in feasibility interviews that will assess acceptability, demand, implementation, and practicality. All subjects will be asked to fill out questionnaires that assess quality of life, physical function, and the ability to complete activities of daily living.

Conditions

Peripheral Arterial Disease

Keywords

Exoskeleton Device

Outcome Measures

Primary Outcomes (1)

• biological ankle torque in Newton meters/kilogram

  The primary outcome variables of biological contribution to ankle torque and power will be calculated from five steps per leg during the flat ground walking. Ground reaction forces for the vertical, anterior-posterior, and medial-lateral direction, and joint angles, joint angular velocity for the hip, knee, and ankle during the stance phase of walking, joint torques and powers are will also be calculated.

  baseline assessment

Secondary Outcomes (4)

• Muscle Oxygenation

  baseline assessment

• Energy cost

  baseline assessment

• Rate of perceived exertion

  baseline assessment

• Claudication Onset and Peak Walking Times (seconds)

  baseline assessment

Study Arms (2)

Older healthy

Individuals over 40 years of age

Device: Exoskeleton footwear

Peripheral artery disease

Individuals over 40 years of age with peripheral artery disease.

Device: Exoskeleton footwear

Interventions

Exoskeleton footwear DEVICE

Assistive footwear

Older healthy; Peripheral artery disease

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Omaha VA Medical Center

You may qualify if:

• Be able to give written, informed consent
• Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks as determined by a health history questionnaire
• Be 40 years of age or older
• Healthy aged selected to match the population of patients with PAD
• Demonstrate negative history of chronic claudication or other exercise limitation as determined by a health history questionnaire
• Meet criteria 1-3 from above
• Demonstrate positive history of chronic claudication pain
• Demonstrate exercise-limiting claudication per history and direct observation
• Have evidence of occlusive disease on ankle/brachial index testing and/or computerized tomographic angiography

You may not qualify if:

• An ankle-brachial index \< 0.90 at rest, as measured by the study team
• Healthy subjects only
• Individuals without symptoms but with reduce blood flow (asymptomatic PAD) will be excluded
• Walking capacity limited by conditions affecting the legs (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Nebraska: collaborator
• Results Group LLC: collaborator

Study Sites (1)

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1850, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Sara A. Myers, PhD

  Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

  PRINCIPAL INVESTIGATOR

• Iraklis I Pipinos, MD

  Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 7, 2020
• Study Start: August 1, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)