Validation of a Bimanual and Scenarized 3D Motion Analysis Protocol of Upper Limbs in Children With Unilateral Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome: Between-day reliability of kinematic parameters (MAX and ROM) will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC) and the Standard Measurement Errors (SEM) from the ICC.
研究概览
简要总结
Cerebral Palsy, in particular in its unilateral spastic form (uCP), is the main cause of motor disability in children, with a prevalence of 2/1000 births. These children have upper limb motor impairments that hinder the realization of activities of daily life in bimanual situations. 3D motion analysis (3DMA) is an objective and precise tool, considered as the gold standard for gait analysis. The existing 3DMA protocols consist of movements too standardized, in unimanual situations away from gestures of everyday life, or have not been validated in bimanual situations.
In a preliminary study, a 3DMA bimanual protocol was study. it was composed of 4 tasks integrated into a game scenario to have more spontaneity of movements, similar to those experienced by children in daily life. It allows the exploration of all degrees of freedom of the upper limb. Results showed an excellent acceptability and within day reliability on 20 uCP children and 20 typically developing children (TDC) for funct
详细描述
This is a prospective study for evaluation of a diagnostic and therapeutic tool.
"Be An Airplane Pilot" 3DMA:
The protocol consists of 5 complementary bimanual tasks that are integrated into a scenario game of "becoming an airplane pilot". It allows the exploration of all degrees of freedom of the UL kinematics of the non-dominant/hemiplegic.
The protocol will take place in a session that corresponds to the driving of an airplane and includes several tasks which consist of 5 repetitions of movements (= 5 cycles).
The kinematics of the trunk (flexion-extension, lateral flexions and rotations), shoulder (elevation, plane of elevation, rotations), elbow (flexion-extension and pronosupination) and wrist (flexion-extension and adduction/abduction) will be explored. The calculated kinematic parameters are the range of motion (ROM) and the maximum angle (MAX) of the degrees of freedom (DoF) of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary outcome: Between-day reliability of kinematic parameters (MAX and ROM) will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC) and the Standard Measurement Errors (SEM) from the ICC.
时间窗: At the end of the participation to the study for each uCP children (2- 4 weeks maximum)
Two kinematic parameters will be studied: MAX (Maximum angle value) and ROM (Range of Motion) parameters, measured in degrees. Outcome measures : * Between-day reliability of MAX will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC). * Between-day reliability of ROM will be studied by calculating a between-day Intra-class Correlation Coefficient (ICC). From ICC, Standard Measurement Errors (SEM) can be calculated. SEM represents from how much degree, it can be considered that the fluctuation is unrelated to chance.
次要结局
未报告次要终点