Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

Diabetic Foot Ulcer Clinical Trial

Official title:

Assistive ExoSkeleton & ExoTendon Platform to Enable Wearable Rehabilitation Robotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717233
• Other study ID #: FB20181
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: October 17, 2019

Study information

• Verified date: February 2020
• Source: Results Group LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Foot
• Diabetic Foot Ulcer
• Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
• Foot Ulcer
• Ulcer

Intervention

Device:
• Exoskeleton
Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot

Locations

Country	Name	City	State
United States	Rancho Los Amigos	Los Angeles	California
United States	Southern CT State University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Results Group LLC	Southern Connecticut State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forefoot plantar pressure	Measurements of the force and pressure on the bottom of the front of the foot	30 minutes
Secondary	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