Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics
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|ClinicalTrials.gov Identifier: NCT03717233|
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : March 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus||Device: Exoskeleton||Not Applicable|
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 (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)|
|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|
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.
Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot
- Forefoot plantar pressure [ Time Frame: 30 minutes ]Measurements of the force and pressure on the bottom of the front of the foot
- 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.
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
|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|