The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Carbon Fiber Custom Dynamic Orthosis
  The carbon fiber custom dynamic orthosis (CDO) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee.
• Устройство Carbon Fiber Footplate
  One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness

Первичные конечные точки

• Peak Forefoot Force [Срок оценки: Baseline]
• Forefoot Force Impulse [Срок оценки: Baseline]
• Peak Hindfoot Force [Срок оценки: Baseline]
• Hindfoot Force Impulse [Срок оценки: Baseline]
• Peak Ankle Power [Срок оценки: Baseline]

Вторичные конечные точки (11)

• Peak Midfoot Force [Срок оценки: Baseline]
• Midfoot Force Impulse [Срок оценки: Baseline]
• Peak Total Foot Force [Срок оценки: Baseline]
• Total Foot Force Impulse [Срок оценки: Baseline]
• Peak Ankle Dorsiflexion [Срок оценки: Baseline]
• Peak Ankle Plantarflexion [Срок оценки: Baseline]
• Ankle Range of Motion [Срок оценки: Baseline]
• Peak Ankle Dorsiflexion Moment [Срок оценки: Baseline]
• Peak Ankle Plantarflexion Moment [Срок оценки: Baseline]
• Numerical Pain Rating Scale [Срок оценки: Baseline]
• Modified Socket Comfort Score (Comfort) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of Iowa — Iowa City

Идентификаторы

NCT: NCT07312032 · 202507360 · 202507360

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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