The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peak Forefoot Force
研究概览
简要总结
Carbon fiber custom dynamic orthoses (CDOs) improve function, reduce pain, and offload the foot and ankle. CDOs include a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy, and a semi-rigid carbon fiber footplate. The purpose of this study is to determine the effect of CDO use and CDO footplate stiffness on foot loading, limb mechanics, pain, and comfort.
详细描述
Carbon fiber custom dynamic orthoses (CDOs) have been used to improve function, reduce pain, and offload the foot and ankle for individuals with a number of conditions affecting the lower extremity.[1-3] CDOs consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy during mid to late stance, a semi-rigid carbon fiber footplate, and, in some cases, a foam heel wedge placed in the shoe. Studies have previously investigated the effects of design characteristics on gait biomechanics and foot loading, however, the effect of foot plate stiffness on resulting foot loading is unknown.
The purpose of this study is to determine the effect of CDO use and CDO footplate stiffness on foot loading, limb mechanics, pain, and comfort. In this study, forces acting under the foot will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) and limb mechanics will be measured using motion capture cameras and force plates as participants walk without an orthosis (NoCDO), with a CDO, and with a CDO plus added carbon fiber stiffening inserts (1/2) at a controlled walking speed. Participants will be provided a heel lift for the contralateral limb to prevent leg length discrepancies during walking if necessary. After walking in each condition, participants will complete questionnaires concerning pain and orthosis comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 65
- •Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
- •Able to hop without pain
- •Able to perform a full squat without pain
- •Ability to read and write in English and provide written informed consent
- •Ability to fit in a generic sized CDO
排除标准
- •Diagnosed with a moderate or severe brain injury
- •Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- •Injuries that would limit performance in this study
- •Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- •Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
- •Require use of an assistive device
- •Unhealed wounds (cuts/abrasions) that would prevent AFO use
- •BMI > 40
- •Pregnancy
结局指标
主要结局
Peak Forefoot Force
时间窗: Baseline
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor).
Forefoot Force Impulse
时间窗: Baseline
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase.
Peak Hindfoot Force
时间窗: Baseline
Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor).
Hindfoot Force Impulse
时间窗: Baseline
Plantar force impulse (Ns) across the hindfoot (proximal 30% sensor) will be calculated using the integral of the force over the stance phase.
Peak Ankle Power
时间窗: Baseline
Peak sagittal plane ankle push-off power (W/kg) during gait.
次要结局
- Peak Midfoot Force(Baseline)
- Midfoot Force Impulse(Baseline)
- Peak Total Foot Force(Baseline)
- Total Foot Force Impulse(Baseline)
- Peak Ankle Dorsiflexion(Baseline)
- Peak Ankle Plantarflexion(Baseline)
- Ankle Range of Motion(Baseline)
- Peak Ankle Dorsiflexion Moment(Baseline)
- Peak Ankle Plantarflexion Moment(Baseline)
- Numerical Pain Rating Scale(Baseline)
- Modified Socket Comfort Score (Comfort)(Baseline)
研究者
Jason Wilken
Associate Professor
University of Iowa