An Adjustable Stiffness Orthosis to Maintain Muscle Engagement and Push-off Power in Cerebral Palsy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in Muscle Activity
研究概览
简要总结
This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.
详细描述
Our first aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor push-off power and range of motion compared to standard (physician prescribed) AFOs during walking in CP.
Our second aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor muscle activity while maintaining improved posture compared to standard AFOs during walking in CP.
Our third aim is to validate the need and usability of real-time stiffness adjustment during play and school activities; obtain feedback from the children, their parents, and orthotists to design the MVP.
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
- 8 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8-35 years old, inclusive
- •Diagnosis of cerebral palsy (CP)
- •Gross motor functional classification score level I, II, or III
- •Physician-prescribed AFOs of common design (i.e., rigid molded thermoplastic)
- •Ability to walk for 6 minutes on a treadmill
- •At least 20° of passive plantar-flexion range of motion
- •No concurrent treatment other than those assigned during the study
- •No condition other than CP that would affect safe participation
- •No surgery within 6 months of participation.
排除标准
- •Excessive knee flexion during walking caused by CP
结局指标
主要结局
Change in Muscle Activity
时间窗: day 1
Change in integrated soleus electromyography (mV/mV) muscle activity during stance phase of walking.
Change in Metabolic Cost of Transport
时间窗: day 1
Change in metabolic cost of transport during walking. To calculate the metabolic cost of transport, the standing baseline metabolic rate for each participant and each trial was subtracted from their walking metabolic rate to estimate the net metabolic rate of walking. Next, we normalized the net metabolic rate of walking by each participant's body mass (m) and walking speed to calculate the metabolic cost of transport (J/kg\*m), averaged over the last two minutes of each condition.
Change in Ankle Power
时间窗: 1 day during walking
Change in peak ankle power during stance phase measured in w/kg. Ankle kinematics and kinetics were calculated in OpenSim using the collected three-dimensional motion capture and the ground reaction forces. The joint kinematics and ground reaction forces were filtered using a low pass fourth order recursive Butterworth filter with a cut-off frequency of 6 Hz before being used to calculate joint kinetics. The ground reaction forces were collected using two force places associated with the instrumented treadmill (Bertec Corp, Columbus, USA) collected at 1200 Hz. The resultant joint kinetics were then further filtered using the same filtering parameters. Ankle joint power was calculated as the product of the joint moment and joint angular velocity.
次要结局
未报告次要终点