SDR-Auswertung, Unterteil Kognition, Bildgebung, Lebensqualität
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Motor function measured by GMFCS
研究概览
简要总结
Selektive dorsal rhizotomy (SDR) has been used as treatment option in children suffering from cerebral palsy (CP) for several decades and multiple studies demonstrated its benefits. Nevertheless, there are still no proven strategies for patient selection, optimal point of time for the operation or pre- and postoperative therapies. The evaluation of the impact of selective motor control, cognition and cerebral imaging findings on the motor outcome and life quality in children with CP who underwent SDR at the Charité University clinics will clarify these critical points in daily care for patients with CP.
详细描述
SDR at the Charité University clinics. Two study visits before surgery and during the follow-up 3 months, 6 months, 12 months, 24 months and 5 years post-operatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of cerebral palsy
- •able to perform most tasks according to study protocols
- •parents and physician decided to perform SDR
排除标准
- •not able to perform any tasks according to study protocols
- •no candidate for SDR
结局指标
主要结局
Motor function measured by GMFCS
时间窗: 5 years
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
Motor function measured by GMFM-88
时间窗: 5 years
Ability of a child to perform specified motor tasks, measured by GMFCS and GMFM-88
次要结局
- Spasticity by modified Tardieu scale(5 years)
- Contractures by range of motion (ROM)(5 years)
- Quality of life measured by "Disabkids"-Questionaire (German version)(5 years)
- Quality of life measured by questionaire "kid screen"(5 years)
- Selective motor control(5 years)
- Spasticity by modified Ashworth scale(5 years)
研究者
Anne van Riesen
MD
Charite University, Berlin, Germany