Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Plantar Force Impulse (forefoot)
研究概览
简要总结
Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.
详细描述
Traumatic lower limb injuries often result in poor functional outcomes with long-term negative effects. Carbon fiber custom dynamic orthoses (CDOs) can improve outcomes by reducing pain, supporting the limb, and transferring forces around the limb through the CDO. CDOs consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. Although CDOs are becoming more commonly prescribed following injury the evidence available to guide clinical practice remains limited. The important role of the proximal cuff has not been systematically examined.
The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics. Two groups of individuals will participate: individuals with post-traumatic osteoarthritis in the ankle and healthy individuals. Testing will occur without an orthosis and while wearing orthoses with four proximal cuff designs representative of currently available devices: 1) a rigid patellar tendon bearing (PTB) clamshell cuff secured using a mechanical ratcheting system, 2) a PTB shell with a fixed pivot point secured with Velcro, 3) a rigid clamshell cuff secured with Velcro, and 4) a semi-rigid cuff with a flexible outer layer secured with Velcro.
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)
盲法说明
Participants will be blinded, to the greatest extent possible, to the different CDO designs and will only be introduced to each device as CUFF-A, CUFF-B, CUFF-C, CUFF-D.
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
- •PARTICIPANTS WITH PTOA:
- •Inclusion Criteria:
- •Diagnosis of ankle PTOA.
- •Ability to walk 50 feet at a slow to moderate pace.
- •Ability to walk without a cane or crutch.
- •Ability to read and write in English and provide written informed consent.
排除标准
- •Diagnosis with a moderate or severe brain injury.
- •Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition…).
- •Ankle weakness as a result of spinal cord injury or nervous system pathology.
- •Nerve, muscle, bone, or other condition limiting function in the contralateral extremity.
- •Rheumatoid or inflammatory arthritis.
- •Necrosis of any bones in the foot or ankle.
- •Pain of 8/10 or greater during walking.
- •Surgery on study limb anticipated in the next 6 months.
- •Uncorrected visual or hearing impairments.
- •Require use of a stabilizing device (i.e. Ankle Foot Orthosis or Knee Orthosis…) to perform daily activities.
- •Body mass index greater than
- •HEALTHY ABLE-BODIED PARTICIPANTS:
- •Inclusion Criteria:
- •Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
- •Ability to hop without pain.
- •Ability to perform a full squat without pain.
- •Ability to read and write in English and provide written informed consent.
- •Exclusion Criteria:
- •Diagnosis with a moderate or severe brain injury.
- •Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition).
- •Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
- •Medical conditions of injuries limiting function for greater than 6 weeks.
- •Uncorrected visual or hearing impairments.
- •Use of an assistive device.
- •Body mass index greater than 35.
结局指标
主要结局
Plantar Force Impulse (forefoot)
时间窗: Baseline
Plantar force impulse (Ns) across the total foot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk in each study condition.
Peak Plantar Force (total foot)
时间窗: Baseline
Force data (N) collected from the total foot (100% of sensor), measured between the foot and orthosis during gait.
Plantar Force Impulse (midfoot)
时间窗: Baseline
Plantar force impulse (Ns) across the total foot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk in each study condition.
Peak Plantar Force (midfoot)
时间窗: Baseline
Force data (N) collected from the total foot (middle 30% of sensor), measured between the foot and orthosis during gait.
PROMIS Patient Reported Outcomes for Physical Function
时间窗: Baseline
The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
PROMIS Patient Reported Outcomes for Pain Interference
时间窗: Baseline
The Patient Reported Outcome Information System (PROMIS) pain interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Plantar Force Impulse (total foot)
时间窗: Baseline
Plantar force impulse (Ns) across the total foot (100% of sensor) will be calculated using the integral of the force over the stance phase as participants walk in each study condition.
Peak Plantar Force (forefoot)
时间窗: Baseline
Force data (N) collected from the total foot (distal 40% of sensor), measured between the foot and orthosis during gait.
Peak Plantar Force (hindfoot)
时间窗: Baseline
Force data (N) collected from the total foot (proximal 30% of sensor), measured between the foot and orthosis during gait.
Numerical Pain Rating Scale
时间窗: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Plantar Force Impulse (hindfoot)
时间窗: Baseline
Plantar force impulse (Ns) across the total foot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk in each study condition.
Participant Device Preference
时间窗: Baseline
The participant will rank order their preference for their standard of care device (if applicable), NoCDO, CUFF-A, CUFF-B, CUFF-C, CUFF-D on a questionnaire.
次要结局
- Modified Socket Comfort Score (Comfort)(Baseline)
- Ankle Range of Motion(Baseline)
- Peak Ankle Power(Baseline)
- Peak Ankle Moment(Baseline)
- Modified Socket Comfort Score (Smoothness)(Baseline)
研究者
Jason Wilken
Associate Professor
University of Iowa