The Influence of Heel Wedge Properties on Roll-over of the Intrepid Dynamic Exoskeletal Orthosis (IDEO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Roll-over shape
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Roll-over shape
时间窗: 2 hours
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
COP velocity
时间窗: 2 hours
This will be calculated by taking the derivative of the COP anterior-posterior position
Instantaneous radius of curvature
时间窗: 2 hours
This will be calculated by taking the derivative of the anterior-posterior progression of the COP with respect to the shank angle
Ankle moment
时间窗: 2 hours
This will be calculated from the Ground Reaction Force (GRF) vector relative to the ankle joint center
次要结局
未报告次要终点
研究者
Andrea J. Ikeda
Research Prosthetist
Brooke Army Medical Center