Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI) Is Nintendo Wii an Effective Intervention for Children With Osteogenesis Imperfecta
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in physical capacity
研究概览
简要总结
Children with osteogenesis imperfecta are described as extremely sedentary and therefore fatigable, which strongly impacts their daily activities. The physical rehabilitation of these children is a fundamental aspect of treatment.
It has been shown that playing Wii console causes the same increase in energy expenditure than practicing moderate exercise, while ensuring user safety. This type of physical exercise with this type of fun game console might have a role in the treatment of OI children on the physical side but also on the psychological side.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Children affiliated to a social security scheme
- •Children diagnosed OI by a competent physician of one of the French specialist centers;
- •OI children type 1 or type 4;
- •Stable OI (far from a fractional episode of at least two months);
- •Children without regular activity on the Nintendo Wii console or other interactive console;
- •Boy or Girl> 6 to 18 years
- •Parents or person having parental authority affiliated to a social security scheme
- •Parents or person having parental authority who signed the consent form for the study.
排除标准
- •- Children who can not walk;
- •Children with severe OI other than type 1 or type 4;
- •Fracture during the last two months;
- •Surgical intervention within the last 8 months;
- •Inability to understand and follow the protocol;
- •Participation in another clinical study;
- •Children, parents or holder of parental authority refusing the written consent.
结局指标
主要结局
Change in physical capacity
时间窗: from baseline to 3 months
Compare the change in physical capacity between training group of children with OI and control group of children with OI. The physical capacity is measured by maximal oxygen consumption VO2 max (ml/min/kg) measured during incremental exercise on cycle ergometer
次要结局
- Compare endurance of lower limbs between training group and control group(Month 9)
- Change in physical capacity(From baseline to 9 months)
- Compare quality of life between training group and control group(Month 9)
- Compare muscle strength between training group and control group(Month 9)
- Training tolerance(Baseline from 9 months)
- Compare physical inactivity between training group and control group(Month 9)
- Compare functional benefit between training group and control group(Month 9)
- Compare body fat between training group and control group(Month 9)
- Compare Energy expenditure of lower limbs between training group and control group(Month 9)