Development of a Robotic Ankle Assist Device to Improve Mobility in Individuals With Movement Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Preferred Walking Speed
研究概览
简要总结
The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy.
The first specific goal is to assess the benefits of repeated gait training with RAAD assistance. Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention.
The second specific goal is to separately assess the benefits of repeated gait training with RAAD resistance. Individuals with CP will participate in a 4-week resistance intervention and mobility outcomes will be quantified pre and post intervention.
Assessed separately, it is hypothesized that both assistance and resistance training will improve mobility outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.
- •Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.
排除标准
- •Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.
- •Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.
结局指标
主要结局
Change in Preferred Walking Speed
时间窗: baseline and post intervention at 6 minutes
How fast someone prefers to walk
次要结局
- Change in COT(baseline and post intervention)
- Change in 6MWT(6 minutes pre/post)
- Change in Gait Kinetics(6 minutes pre/post)
- Change in Step Length(baseline and post intervention)
- Change in Gross Motor Function Measure Scale 66(20 minutes pre/post)
- Change in Fast Walking Speed(baseline and post intervention)