Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change of gross motor function (GMFM-66)
研究概览
简要总结
Cerebral Palsy (CP) is the most common cause of physical disability in childhood. Up to day the investigators have treated children diagnosed cerebral palsy with side-alternating whole body vibration (System Galileo®) from the age of two years on. Considering verticalisation (standing and walking) at about 12 months of age in a normal developing child the investigators suggest the introduction of verticalisation with whole body vibration to a child with CP at this early age in order to enhance motor development and participation.
In this pilot study the investigators will test the feasibility and the effect on motor development of whole body vibration in children with CP from 12 months of age. The investigators will investigate the effect of whole body vibration on motor performance, independence in all day living situations, quality of life and contractures compared to a control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed CP
- •≥ 12 months and ≤ 24 months of age (prematures corrected age)
- •GMFCS level II, III, IV
- •Inability to stand and walk
- •Written informed consent of legal guardian
排除标准
- •Chronic infectious disease
- •Epilepsy not responding to therapy
- •Additional severe congenital disorder (e.g. congenital heart disorder)
- •Surgery in previous three months
- •Hernia requiring surgery
- •Treatment with Botulinumtoxin
- •Acute Thromboses
- •Implants and tendinitis in body parts to be trained
- •Acute inflammation in the musculoskeletal system
- •Slipped disc
- •Rheumatoid arthritis
- •Fractures in previous three months
- •Intracerebral bleeding in previous three months
- •Planned surgery in study period
- •Participation at another interventional trial
- •Gall stones, kidney stones and pregnancy of the person who trains with the child
结局指标
主要结局
Change of gross motor function (GMFM-66)
时间窗: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
次要结局
- Health-related quality of life (PedsQL)(Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up))
- Participation in activities in daily life (PEDI)(Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up))
- Passive Range of Motion (PROM)(Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up))
- Training compliance(Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up))
研究者
Christina Stark
Staff member at the muscle-bone research group
University of Cologne