TERMINATED

Exoskeleton Variability Optimization

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 algorithms (i.e., human-in-the-loop) to optimize the assistance profile with real-time metabolic measurements. The needed duration of current human-in-the-loop (HITL) algorithms range from 20 minutes to 1 hour which is longer than the average duration that most patients with peripheral artery disease (PAD) can walk. Because of this limited walking duration, it is often not possible for patients with PAD to reach steady-state metabolic cost, which makes these measurements are not useful for optimizing exoskeletons. In this study, investigators intend to develop and evaluate HITL optimization methods for exoskeletons and use the information to design and evaluate a portable hip exoskeleton. Shorter and more clinically feasible HITL optimization strategies based on experiments in healthy adults might allow utilizing these optimization strategies to become available for patient populations such as patients with PAD.

Official Title

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

Quick Facts

Study Start:2022-01-31
Study Completion:2025-03-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04338815

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide written consent
  2. * Chronic claudication history
  3. * Ankle-brachial index \< 0.90 at rest
  4. * Stable blood pressure, lipids, and diabetes for \> 6 weeks
  5. * Ability to walk on a treadmill for multiple five-minute spans
  6. * Ability to fit in exoskeleton
  7. * Waist circumference 78 to 92 centimeters (31 to 36 inches)
  8. * Thigh circumference 48 to 60 centimeters (19 to 24 inches)
  9. * Minimal thigh length 28 centimeters (11 inches)
  1. * Resting pain or tissue loss due to peripheral artery disease (PAD, Fontaine stage III and IV)
  2. * Foot ulceration
  3. * Acute lower extremity event secondary to thromboembolic disease or acute trauma
  4. * Walking capacity limited by diseases unrelated to PAD, such as:
  5. * Neurological disorders
  6. * Musculoskeletal disorders (arthritis, scoliosis, stroke, spinal injury, etc.)
  7. * History of ankle instability
  8. * Knee injury
  9. * Diagnosed joint laxity
  10. * Lower limb injury
  11. * Surgery within the past 12 months
  12. * Joint replacement
  13. * Pulmonary disease or breathing disorders
  14. * Cardiovascular disease
  15. * Vestibular disorder
  16. * Acute injury or pain in lower extremity
  17. * Current illness
  18. * Inability to follow visual cues due to blindness
  19. * Inability to follow auditory cues due to deafness
  20. * Pregnant

Contacts and Locations

Principal Investigator

Philippe Malcolm
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

University of Nebraska Omaha
Omaha, Nebraska, 68182
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Philippe Malcolm, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-31
Study Completion Date2025-03-28

Study Record Updates

Study Start Date2022-01-31
Study Completion Date2025-03-28

Terms related to this study

Keywords Provided by Researchers

  • Exoskeleton

Additional Relevant MeSH Terms

  • Peripheral Arterial Disease