Effect of Custom Dynamic Orthoses on Forefoot Loading
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Peak Plantar Force (Forefoot)
研究概览
简要总结
The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.
详细描述
This study is designed to evaluate the effects of initial accommodation, CDO related training, and take-home use on foot loading during gait. In this study, adult participants who experienced an injury below the knee and require a CDO will walk without the CDO, then with the CDO following initial prescription, after training with or without visual force feedback, and after additional take-home use of the CDO. Participants will be randomized to to training with or without visual feedback of foot loading forces.
Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants will not be blinded to which study arm they are assigned.
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
- 否
入选标准
- •Patient Inclusion criteria
- •Ages: 18-65
- •Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
- •Shoe size between women's 8 and 13.5 or men's 6.5 and 13
- •Any of the following: weakness of ankle plantarflexors (<4/5 on MMT), limited pain free ankle motion (DF<10deg or PF<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
- •Ability to walk 25 feet without using a cane or crutch
- •Ability to walk at a slow to moderate pace
- •Able to read and write in English and provide written informed consent
排除标准
- •Pain > 9/10 while walking
- •Ankle weakness as a result of spinal cord injury or central nervous system pathology
- •AFO or CDO prescription that includes a knee brace or goes up to thigh
- •Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
- •Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
- •BMI greater than 40
- •Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
- •Pregnancy
研究组 & 干预措施
Provided Visual Feedback
Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO.
干预措施: Visual Feedback (Other)
No Visual Feedback
Participants will receive typical accommodation training after being prescribed the CDO.
结局指标
主要结局
Peak Plantar Force (Forefoot)
时间窗: Baseline
Maximum force (N) collected from the forefoot (distal 40% of sensor) during gait.
Plantar Force Impulse (Forefoot)
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 as participants walk.
次要结局
- Peak Plantar Force (Midfoot)(Baseline)
- Plantar Force Impulse (Midfoot)(Baseline)
- Peak Plantar Force (Hindfoot)(Baseline)
- Plantar Force Impulse (Hindfoot)(Baseline)
- Peak Plantar Force (Total Foot)(Baseline)
- Plantar Force Impulse (Total Foot)(Baseline)
研究者
Jason Wilken
Associate Professor
University of Iowa