Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics
Completed · Not applicable
Conditions studied: Diabetic Foot Ulcer, Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03717233
- Run by
- Results Group LLC
- People needed
- 40
- Starts
- 2018-10-18
- Expected to finish
- 2019-10-17
- Last updated by the study team
- 2020-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Self-reported history of diabetic foot ulcer
You may not qualify if…
- 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 .
Where it is running
- Rancho Los Amigos — Los Angeles, California, United States
- Southern CT State University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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