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Exoskeleton Footwear to Improve Walking

NCT04337554 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2025-10-16

No results posted yet for this study

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

Interventions

DEVICE

Exoskeleton footwear

Assistive footwear

Sponsors & Collaborators

  • University of Nebraska

    collaborator OTHER

  • Results Group LLC

    collaborator INDUSTRY

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Sara A. Myers, PhD · Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

  • Iraklis I Pipinos, MD · Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04337554 on ClinicalTrials.gov