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Exoskeleton Footwear to Improve Walking

NCT04337554 · VA Office of Research and Development · Updated 2 Oct 2026

What is being tested
Exoskeleton footwear
For
Peripheral Arterial Disease
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 40 years and older. About 47 people. The full rules are on the registry page.
Where
United States
When
Starts or started 1 Aug 2020, ends 30 Aug 2026. Registered 7 April 2020.
Results
None posted yet.

In the researchers' words

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.…
ClinicalTrials.gov, NCT04337554

Sites

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmaha, Nebraska, United States