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Exoskeleton Optimization for Peripheral Artery Disease

N/A

Recruiting

Led By Philippe Malcolm

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to fit in exoskeleton: waist circumference 78 to 92 centimeters, thigh circumference 48 to 60 centimeters, minimal thigh length 28 centimeters

Ability to walk on a treadmill for multiple five-minute spans

Must not have

Rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV)

Acute lower extremity event secondary to thromboembolic disease or acute trauma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 seconds

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, faster method to optimize exoskeletons for people with peripheral artery disease.

Who is the study for?

This trial is for individuals who can legally consent and have chronic leg pain due to poor blood flow (Peripheral Vascular Disease or Peripheral Arterial Disease), with specific measurements of blood flow, stable health conditions, and the ability to walk on a treadmill. They must fit certain physical criteria related to waist, thigh size, and length. Pregnant women and those with severe disease stages or other major health issues are excluded.

What is being tested?

The study is testing a new way to adjust exoskeletons that might be quicker and more practical in clinical settings. It's being piloted on healthy subjects first before moving on to patients with peripheral artery disease. The focus is on how well these optimized exoskeletons help with endurance.

What are the potential side effects?

Since this trial involves mechanical assistance rather than drugs, side effects may include discomfort from wearing the exoskeleton, potential skin irritation at contact points, muscle soreness after use, or fatigue during endurance evaluations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I meet the size requirements for the exoskeleton.

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I can walk on a treadmill for several 5-minute periods.

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I have a history of leg pain when walking.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe leg pain or tissue loss because of poor blood flow.

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I recently had a blood clot or injury affecting my leg.

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I am currently experiencing pain or have an injury in my leg.

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I have a foot ulcer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 seconds

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 seconds

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 seconds for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Largest lyapunov exponent

Peak extension timing

Peak flexion timing

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Optimal assistance patternExperimental Treatment1 Intervention

An optimization algorithm will change the assistance pattern on the hip exoskeleton during walking sessions and the optimal assistance pattern will be determined when gait variability is minimized.

Group II: Effects on enduranceExperimental Treatment1 Intervention

Determine effects on endurance of participants using ground reaction force (Bertec treadmill), walking speed (Bertec treadmill), indirect calorimetry (Cosmed), and motion capture (Vicon).

0 / 7Eligibility criteria met