Status:
COMPLETED
Exoskeleton Footwear to Improve Walking
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Nebraska
Results Group LLC
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40+ years
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). T...
Detailed Description
Claudication due to peripheral artery disease (PAD) causes patients to walk less and slower, lose independence in daily living activities, and be sedentary compared to their healthy counterparts. The ...
Eligibility Criteria
Inclusion
- Inclusion criteria for healthy older: At entry into the study, all subjects must:
- 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
- Inclusion criteria for patients with PAD: At entry into the study, all subjects must:
- 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
Exclusion
- Exclusion criteria for healthy older, any potential subjects will be excluded if they have:
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04337554
Start Date
August 1 2020
End Date
September 30 2025
Last Update
October 16 2025
Active Locations (1)
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1
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850