An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Toe Walking Severity (TWS) index
研究概览
简要总结
The present project will focus on evaluating the technical efficacy of the in-shoe gait monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.
详细描述
The investigators on this protocol intend to develop the device and rely on it to propose a Toe Walk Severity (TWS) index, a novel outcome measure for quantifying changes in severity of toe walking over time and for assessing the outcome of surgical and non-surgical interventions.
Tasks include:
A.Validate data acquisition measurements in laboratory setting compared to gold-standard video analysis and field (outside of laboratory).
B.Develop multi-stage classification algorithm from subset of laboratory and field data.
C.Validate classification algorithm against random subsets of laboratory and field data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able to ambulate 50 feet on level ground without the assistance of a person
- •able to ambulate on ramps and stairs without the assistance of a person
- •demonstrate a toe-walking pattern at the time of enrollment
- •medically stable
- •able to understand directions and follow simple instructions
排除标准
- •any cardiopulmonary, orthopedic, and neurological conditions other than CP that would prevent them from performing the motor tasks of interest
结局指标
主要结局
Toe Walking Severity (TWS) index
时间窗: 1 day
Measure for quantifying changes in severity of toe walking over time based on Center of Pressure trajectories computed by the sensorized insole
次要结局
- Edinburgh Visual Scale (EVS) score(1 day)
研究者
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital