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Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717233
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
Southern Connecticut State University
Information provided by (Responsible Party):
Results Group LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus Device: Exoskeleton Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be evaluated as their own controls.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assistive ExoSkeleton & ExoTendon Platform to Enable Wearable Rehabilitation Robotics
Actual Study Start Date : October 18, 2018
Actual Primary Completion Date : October 17, 2019
Actual Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary Arm
Participants will be used as their own controls. Participants will be evaluated using exo-skeletons with non-motorized spring elements in parallel to the Achilles tendon. Up to 5 different levels of spring force will be evaluated to evaluate the impact upon plantar pressure and measures of fall risk.
Device: Exoskeleton
Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot




Primary Outcome Measures :
  1. Forefoot plantar pressure [ Time Frame: 30 minutes ]
    Measurements of the force and pressure on the bottom of the front of the foot


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717233


Locations
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United States, California
Rancho Los Amigos
Los Angeles, California, United States, 90242
United States, Connecticut
Southern CT State University
New Haven, Connecticut, United States, 06515
Sponsors and Collaborators
Results Group LLC
Southern Connecticut State University

Publications:
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Responsible Party: Results Group LLC
ClinicalTrials.gov Identifier: NCT03717233    
Other Study ID Numbers: FB20181
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetes Mellitus, Type 2
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Glucose Metabolism Disorders
Metabolic Diseases