An interventional study of Heel Cushion Material Bulk (foam) in Physical Disability, sponsored by Brooke Army Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Brooke Army Medical Center · Not applicable, Interventional, and Treatment
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.
The proposed study includes a between groups comparison (for Aim 1) and a fully repeated crossover design (for Aim 2). It will be conducted in the Military Performance Lab (MPL) at the Center for the Intrepid (CFI), Brooke Army Medical Center, Joint Base San Antonio (JBSA)Fort Sam Houston, Texas. Subjects who use IDEOs will come to the Military Performance Lab for one test session during which they will walk in standardized shoes with six different heel wedges in random order. Control data will also be collected on able-bodied individuals. Control subjects will also come to the MPL for one test session in which they will walk using the same standardized shoes. For all subjects, biomechanical gait data will be collected as the subjects walk along a walkway in the MPL. This data will be used to calculate roll-over shape, instantaneous radius of curvature, Center of Pressure (COP) velocity, and ankle moment.
Brooke Army Medical Center is the lead sponsor of 92 studies on the registry; 11 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
IDEO Group
Inclusion Criteria:
Exclusion Criteria:
Control Group
Inclusion Criteria:
Control Group Exclusion Criteria:
Subjects who use IDEOs will come to the Military Performance Lab for one test session during which they will walk in standardized shoes with six different foam heel wedges (Heel Cushion Material Bulk (foam) from Kingsley Manufacturing Company) in random order. Control data will also be collected on able-bodied individuals. Control subjects will also come to the MPL for one test session in which they will walk using the same standardized shoes. For all subjects, biomechanical gait data will be collected as the subjects walk along a walkway in the MPL. This data will be used to calculate roll-over shape, instantaneous radius of curvature, COP velocity, and ankle moment.
Device: Heel Cushion Material Bulk (foam)
The heel wedge is made of a rubber style urethane foam. Heel wedges of specified heights and durometers will be inserted into the standard shoes, one at a time, during the test session only. The heel wedges used during the test session are made of the same foam as the heel wedges that are used clinically.
Roll-over shape
This will be calculated by determining the COP location in the coordinate system of the shank. The shape will be described by the calculated arc length and best-fit radius of curvature
Time frame: 2 hours
Instantaneous radius of curvature
This will be calculated by taking the derivative of the anterior-posterior progression of the COP with respect to the shank angle
Time frame: 2 hours
COP velocity
This will be calculated by taking the derivative of the COP anterior-posterior position
Time frame: 2 hours
Ankle moment
This will be calculated from the Ground Reaction Force (GRF) vector relative to the ankle joint center
Time frame: 2 hours
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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