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Exoskeleton Variability Optimization

NCT04338815 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-06-19

Study results available
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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 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.

Conditions

  • Peripheral Arterial Disease

Interventions

OTHER

Exoskeleton Optimization

Participants will walk 10-minute trials while an optimization algorithm changes the assistance profile of the exoskeleton.

OTHER

Endurance Evaluation

Participants will walk 2 trials at a speed of 1 meter per second until the participant indicates claudication or a maximum duration of 6 minutes, which ever comes first.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Philippe Malcolm · University of Nebraska

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2025-03-28
Completion
2025-03-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338815 on ClinicalTrials.gov