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Completed

NCT Number: NCT03717233

Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will wear the exo-skeletons and walk in a safe environment. Measurements will be taken to determine how the exo-skeletons affect the pressure on the feet of people with diabetic foot ulcer and how they walk.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Los Amigos, Los Angeles, California, United States

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About this study

Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will include those with self-described history of Diabetic Foot Ulcer and age-matched healthy volunteers. Participants will wear the exo-skeletons and will be asked to walk 32 feet, and to stand quietly for 30 seconds.

Measurements will be taken to evaluate how the exoskeletons affect how people walk, and will also evaluate the pressure on the bottom of their feet. These measurements will be repeated multiple times to evaluate four different exo-tendon spring rates, and two sets of control shoes.

Exo-skeletons have been shown to reduce the pressure on the bottoms of people's feet and to reduce the effort to walk. This study is necessary to understand the contribution of different levels of exo-skeleton spring force to these effects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-reported history of diabetic foot ulcer

Exclusion criteria

  • Unable to continuously ambulate/walk ≥ 40 feet without an assistive device, such as a cane or walker
  • Signs/symptoms of an infected foot lesion/ulcer as determined by a basic foot exam
  • Trans-metatarsal foot amputation or more significant amputation.
  • Symptomatic for signs/symptoms of cardiovascular disease as determined from interpretation of the 2017 PAR-Q+ (predicated on participant responses of "yes" indicating symptomatic/unstable medical conditions to page 2 and page 3 of the 2017 PAR-Q)
  • Participants will be excluded from this study if they demonstrate pre-participation, or chronic, signs/symptoms of hypoglycemia: Confusion, unusual headache, unusual visual disturbances, self-reported mental dullness, shakiness, self-reported weakness, abnormal sweating, undue nervousness/anxiety, and/or tingling of the mouth, toes, and/or fingers or if they answer yes to question 5b and 5c of the 2017 PAR-Q+ .
  • Participants will be temporarily excluded from this study if they are symptomatic for acute illness such as cold or fever. If the participant is symptomatic for acute illness such as cold or fever, participation will be reconsidered upon illness resolution.
  • If participants answer yes to question 4a of the 2017 PAR-Q+ and if they demonstrate pre-study participation resting blood pressure < 90/60 mmHg and >140/90 mmHg .

Treatment and study plan

Exoskeleton

Device

Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot

Primary outcomes

  1. Forefoot plantar pressure

    Time frame: 30 minutes

    Measurements of the force and pressure on the bottom of the front of the foot

Secondary outcomes

  1. Measures of fall risk

    Time frame: 30 minutes

    Measurements of postural sway, balance and gait speed to provide an indication of participant's risk of falling while wearing different shoes.

Sponsors and collaborators

Lead sponsor

Results Group LLC

Industry

Collaborators

  • Southern Connecticut State University

Registry information

Official study title

Assistive ExoSkeleton & ExoTendon Platform to Enable Wearable Rehabilitation Robotics

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2018
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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