The Influence of Heel Wedge Properties on Roll-over of the Intrepid Dynamic Exoskeletal Orthosis (IDEO)
Completed · Not applicable
Conditions studied: Physical Disability
In brief
The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a type of ankle foot orthosis designed to reduce pain and improve function for individuals with foot/ankle pain and/or weakness. Because the IDEO restricts ankle movement, the geometry and mechanics of the device must be designed to allow for a smooth roll-over as the patient walks with the IDEO. The heel wedge, while not physically part of the IDEO, is an integral part of the IDEO-heel wedge-shoe "system". The goal of this research is to determine how heel wedge properties may contribute to the smoothness of roll-over during gait. Insight into the effects of heel wedge properties on roll-over will help optimize the design of the IDEO-heel wedge-shoe "system" and may produce guidelines for the customization of these features.
Key facts
- Study ID
- NCT02509819
- Run by
- Brooke Army Medical Center
- People needed
- 24
- Starts
- 2015-07-01
- Expected to finish
- 2017-08-23
- Last updated by the study team
- 2019-01-16
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- DEERS (Defense Enrollment Eligibility Reporting System) eligible patients at the CFI
- 18 - 55 years old
- Have a unilateral lower extremity injury resulting in foot/ankle weakness and/or pain
- Currently using an IDEO
- Use of the IDEO for greater than two weeks
- Able to ambulate without an assistive device
- Able to comply with gait analysis
- Able to provide written informed consent
You may not qualify if…
- Neurologic, musculoskeletal or other disease state affecting the contralateral limb that limits normal locomotion
- Spinal cord injury or central nervous system pathology
- Medical or psychological disease that would preclude safe gait analysis (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia, etc.)
- Pain level of 4 or greater on a 0-10 scale
- Any open wound or infection on the foot
- Pregnancy
- Control Group
- Inclusion Criteria:
- DEERS eligible
- 18 - 55 years old
- Have no lower extremity injury which affects normal locomotion
- Able to comply with gait analysis
- Able to provide written informed consent
- Control Group Exclusion Criteria:
- Neurologic, musculoskeletal or other disease state that limits normal locomotion
- Previous lower extremity injury requiring surgery (e.g. anterior cruciate ligament tear, femur fracture, etc) or currently affecting normal locomotion
- Any pain that affects normal locomotion
- Any open wound or infection on the foot
- Spinal cord injury or central nervous system pathology
- Medical or psychological disease that would preclude safe gait analysis (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia, etc.)
- Pregnancy
Where it is running
- Brooke Army Medical Center — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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