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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
Stable blood pressure, lipids, and diabetes for > 6 weeks
Ability to fit in exoskeleton: waist circumference 78 to 92 centimeters, thigh circumference 48 to 60 centimeters, minimal thigh length 28 centimeters
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 seconds
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My blood pressure, cholesterol, and diabetes have been stable for over 6 weeks.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Largest lyapunov exponent
Peak extension timing
Peak flexion timing
+1 more

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).

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
535 Previous Clinical Trials
1,143,884 Total Patients Enrolled
11 Trials studying Peripheral Arterial Disease
482 Patients Enrolled for Peripheral Arterial Disease
Philippe MalcolmPrincipal InvestigatorUniversity of Nebraska

Media Library

Exoskeleton optimization Clinical Trial Eligibility Overview. Trial Name: NCT04338815 — N/A
Peripheral Arterial Disease Research Study Groups: Optimal assistance pattern, Effects on endurance
Peripheral Arterial Disease Clinical Trial 2023: Exoskeleton optimization Highlights & Side Effects. Trial Name: NCT04338815 — N/A
Exoskeleton optimization 2023 Treatment Timeline for Medical Study. Trial Name: NCT04338815 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been accepted into this clinical trial?

"Confirmed. Information available on clinicaltrials.gov verifies that this medical trial is open for recruitment, having been initiated on January 31st 2022 and most recently updated November 4th 2022. 22 patients are requested to join at a single site."

Answered by AI

Is there an opportunity for me to participate in this experiment?

"22 individuals, aged 19-85 and afflicted with peripheral arterial disease, are suitable for participation in this trial. Furthermore, they must satisfy the following conditions: Be legally competent to give consent; Exhibit chronic claudication symptoms; Possess a waist circumference of 78 – 92 cm and thigh length between 48 - 60cm (with minimum 28cm); Have an ankle-brachial index below 0.90 at rest; Demonstrate stable blood pressure levels alongside regulated lipides/diabetes over 6 weeks period; Walk on treadmill for multiple 5 minutes spans without difficulty."

Answered by AI

Does the eligibility criteria of this study extend to those over 30 years old?

"This research is recruiting participants who are 19 years or older and 85 years old or younger."

Answered by AI

Are volunteers still being sought for this research project?

"According to clinicaltrials.gov, this medical research is recruiting participants as of November 4th 2022. Initially posted on January 31st, the trial has been updated in the interim."

Answered by AI
~4 spots leftby Sep 2024