Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

Assistive ExoSkeleton & ExoTendon Platform 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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
• Intervention / Treatment: Device: Exoskeleton

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90242
      • Rancho Los Amigos
  • Connecticut
    • New Haven, Connecticut, United States, 06515
      • Southern CT State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forefoot plantar pressure	Measurements of the force and pressure on the bottom of the front of the foot	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures of fall risk	Measurements of postural sway, balance and gait speed to provide an indication of participant's risk of falling while wearing different shoes.	30 minutes

Collaborators and Investigators

• Sponsor: Results Group LLC
• Collaborators: Southern Connecticut State University

Publications and helpful links

General Publications

• Roser MC, Canavan PK, Najafi B, Cooper Watchman M, Vaishnav K, Armstrong DG. Novel In-Shoe Exoskeleton for Offloading of Forefoot Pressure for Individuals With Diabetic Foot Pathology. J Diabetes Sci Technol. 2017 Sep;11(5):874-882. doi: 10.1177/1932296817726349.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): October 17, 2019
• Study Completion (Actual): October 17, 2019

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetes Mellitus, Type 2; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: FB20181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No