Status:
TERMINATED
Exoskeleton Variability Optimization
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
19-85 years
Phase:
NA
Brief Summary
Exoskeletons, wearable devices that assist with walking, can improve mobility in clinical populations. With exoskeletons, it is crucial to optimize the assistance profile. Recent studies describe algo...
Detailed Description
Exoskeletons, wearable devices that assist with walking, can improve mobility in clinical populations. With exoskeletons, it is crucial to optimize the assistance profile. Recent studies describe algo...
Eligibility Criteria
Inclusion
- Ability to provide written consent
- Chronic claudication history
- Ankle-brachial index \< 0.90 at rest
- Stable blood pressure, lipids, and diabetes for \> 6 weeks
- Ability to walk on a treadmill for multiple five-minute spans
- Ability to fit in exoskeleton
- Waist circumference 78 to 92 centimeters (31 to 36 inches)
- Thigh circumference 48 to 60 centimeters (19 to 24 inches)
- Minimal thigh length 28 centimeters (11 inches)
Exclusion
- Resting pain or tissue loss due to peripheral artery disease (PAD, Fontaine stage III and IV)
- Foot ulceration
- Acute lower extremity event secondary to thromboembolic disease or acute trauma
- Walking capacity limited by diseases unrelated to PAD, such as:
- Neurological disorders
- Musculoskeletal disorders (arthritis, scoliosis, stroke, spinal injury, etc.)
- History of ankle instability
- Knee injury
- Diagnosed joint laxity
- Lower limb injury
- Surgery within the past 12 months
- Joint replacement
- Pulmonary disease or breathing disorders
- Cardiovascular disease
- Vestibular disorder
- Acute injury or pain in lower extremity
- Current illness
- Inability to follow visual cues due to blindness
- Inability to follow auditory cues due to deafness
- Pregnant
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04338815
Start Date
January 31 2022
End Date
March 28 2025
Last Update
June 19 2025
Active Locations (1)
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1
University of Nebraska Omaha
Omaha, Nebraska, United States, 68182