Optimizing exoskeletons for patients with peripheral artery disease

Exoskeleton Variability Optimization for Reducing Gait Variability for Patients With Peripheral Artery Disease

This study is testing a new way to make exoskeletons work better for people with peripheral artery disease to help them walk more easily.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 19 Years to 85 Years
• Sex: All
• Sponsor: University of Nebraska (other)
• Locations: 1 site (Omaha, Nebraska)
• Trial ID: NCT04338815 on ClinicalTrials.gov

What this trial studies

This study evaluates a new method for optimizing exoskeletons to assist individuals with peripheral artery disease. It involves a habituation session to the hip exoskeleton, followed by an optimization session that uses a real-time algorithm to determine the best settings for the device. The effectiveness of the optimization will be assessed through various measurements, including muscle activity, walking speed, and energy expenditure. The goal is to prepare for future applications of exoskeletons in patients suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates are individuals with chronic claudication and an ankle-brachial index of less than 0.90 who can walk on a treadmill.

Not a fit: Patients with severe peripheral artery disease, such as those experiencing rest pain or tissue loss, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved mobility and quality of life for patients with peripheral artery disease through enhanced exoskeleton technology.

How similar studies have performed: While the approach of optimizing exoskeletons is innovative, similar studies have shown promise in enhancing mobility for patients with various conditions.

Eligibility criteria

Inclusion Criteria:

* Ability to provide written consent
* Chronic claudication history
* Ankle-brachial index \< 0.90 at rest
* Stable blood pressure, lipides, 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, thigh circumference 48 to 60 centimeters, minimal thigh length 28 centimeters.

Exclusion Criteria:

* Rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV).
* Foot ulceration.
* Acute lower extremity event secondary to thromboembolic disease or acute trauma
* Walking capacity limited by diseases which are unrelated to peripheral artery disease such as:

Neurological disorders, musculoskeletal disorders (arthritis, scoliosis, stroke, spinal injury, etc.), a 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, or vestibular disorder. This will be determined by verbal questioning from research personnel by verbally asking about conditions limiting their walking, whether subjects are taking medications for those conditions, and physicians' recommendations about limiting activity.

* Acute injury or pain in their lower extremity or current illness.
* Inability to follow visual cues due to blindness.
* Inability to follow auditory cues due to deafness.
* Women who are currently pregnant are excluded for safety reasons.

Where this trial is running

Omaha, Nebraska

• University of Nebraska Omaha — Omaha, Nebraska, United States (RECRUITING)

Study contacts

• Principal investigator: Philippe Malcolm — University of Nebraska
• Study coordinator: Philippe Malcolm, PhD

Conditions: Peripheral Arterial Disease, Exoskeleton