A Randomized Cross-over Design Evaluating the Effects of Using a Rehabilitation-specific Gaming Software Platform for the Achievement of Individual Physiotherapy Goals of Children With Severe Spastic Cerebral Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Goal Attainment Scale (GAS)
研究概览
简要总结
The aim of this project is to evaluate the effectiveness of using rehabilitation-specific gaming in physical therapy of children with cerebral palsy.
The primary goal of this project is to evaluate the effectiveness of integrating 15 to 20 minutes of gaming using a rehabilitation-specific gaming platform into standard physiotherapy sessions on the achievement of individual goals of children with bilateral spastic cerebral palsy with GMFCS level III-IV.
The secondary goal of this project is to evaluate the effectiveness of integrating 15 to 20 minutes of gaming using a rehabilitation-specific gaming platform into standard physiotherapy sessions on trunk control and gross motor function of children with bilateral spastic cerebral palsy with GMFCS level III-IV.
详细描述
Forty children are recruited via the Cerebral Palsy Reference Centre (University Hospital Leuven, Pellenberg). Children are recruited when they have been diagnosed with bilateral spastic CP, Gross Motor Function Classification (GMFCS) level III-IV, aged between 6 and 15y and standardly receive physiotherapy at an intensity of minimally 2 times per week, 45 minutes per session.
Children are randomized into the intervention group (conventional, usual therapy including the use of rehabilitation-specific gaming) or the control group (PT, usual physiotherapy not including gaming), followed by a cross-over. After the intervention period of 3 months, wash-out period will be organized to evaluate follow-up effects.
During the intervention period, the usual individual physiotherapy program of the child will be continued as performed before the study and will be executed by the child's usual, familiar physiotherapist. The therapist will be asked to use the rehabilitation-specific gaming software every therapy session, for at least 15 to 20 minutes. The therapist will receive an extensive introduction and demonstration of the software and the researchers will participate in at least one therapy session.
During the control period, the usual, conventional physiotherapy of the child will be continued and the therapist will be asked not to use any gaming activities. Also during the control period, the frequency and duration of the therapy sessions will not be influenced by the researchers.
A wash-out period in between both programs, assumes that therapy effects are still present for a certain period after the intervention and therefore aims to wash-out these effects. Therefore, this period is considered after each intervention period. As during the control period, therapy will be continued as usual during the washout-period but no gaming is allowed during therapy.
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
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral Spastic CP
- •Gross Motor Function Classification (GMFCS) level III-IV,
- •Aged between 6 and 15y
- •Standardly receive physiotherapy at an intensity of minimally 2 times per week, 45 minutes per session.
排除标准
- •received multilevel surgery in the previous year
- •visual acuity <3/10
研究组 & 干预措施
Control period
In this group conventional physiotherapy of the child will be continued and the therapist will be asked not to use any gaming activities. Also during the control period, the frequency and duration of the therapy sessions will not be influenced by the researchers.
Intervention period
In this group the usual individual physiotherapy program of the child will be continued as performed before the study and will be executed by the child's usual, familiar physiotherapist. The therapist will be asked to use the rehabilitation-specific gaming software every therapy session, for at least 15 to 20 minutes. The therapist will receive an extensive introduction and demonstration of the software and the researchers will participate in at least one therapy session.
干预措施: Rehabilitation-specific gaming platform (Other)
Wash-out period
The wash-out period is considered after each intervention period. As during the control period, therapy will be continued as usual during the washout-period but no gaming is allowed during therapy.
结局指标
主要结局
Goal Attainment Scale (GAS)
时间窗: 3 months
Evaluates the achievement of the individual goals per child and allows comparison of a heterogeneous group of children. GAS is essentially conducted on a 5-point measure, with the degree of attainment captured for each goal area. If the patient achieves the expected level, this is scored at 0. If they achieve a better than expected outcome this is scored at: +1 (Somewhat better), +2 (much better). If they achieve a worse than expected outcome this is scored at: -1 (Somewhat worse) or -2 (much worse). Goals may be weighted to take account of the relative importance of the goal to the individual, and/or the anticipated difficulty of achieving it. Overall Goal Attainment Scores are then calculated by applying a formula. The composite GAS (the sum of the attainment levels x the relative weights for each goal) is transformed into a standardised measure or T score with a mean of 50 and standard deviation of 10.
次要结局
- Pediatric Balance Scale (PBS)(3 months)
- Trunk Control Measurement Scale (TCMS)(3 months)
- Gross Motor Function Measure-88 (GMFM)(3 months)