The Effect of Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Gross Motor Function Classification System (GMFCS)
研究概览
简要总结
Abstract Objective: This study planned to examine the effect of Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI) on occupational performance, occupational satisfaction and functional performance in children with diplegic cerebral palsy (DCP).
Materials and Methods: This study was designed as a randomized controlled trial. 34 children with DCP (14 boys; 20 girls) who received routine therapy included to the study. All children were classified according to the Gross Motor Function Classification System (GMFCS) and the Manual Abilities Classification System (MACS). Participants were randomly divided into two groups: the GD-TG-PBI group (number =17; mean age: 7.70±2.25 years) and the control group (number =17; mean age: 7.41±2.06 years). Both groups received routine therapy twice a week for 45 minutes per session during 8 weeks; while the GD-TG-PBI group received GD-TG-PBI additional to routine therapy twice a week for 45 minutes per session during 8 weeks. Occupational performance and satisfaction were determined with the Canadian Occupational Performance Measure (COPM), and functional performance was evaluated with the Pediatric Evaluation of Disability Inventory (PEDI). The COPM and PEDI were performed before and after the intervention for both groups. Dİfferences between COPM and PEDI values before and after the intervention calculated, additionally the effect size of each parameter calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria of the study were a spastic DCP diagnosis, being aged 4-12 years, Gross Motor Function Classification System (GMFCS) level I, II or III, and Manual Ability Classification System (MACS) level I or II, and ability to follow verbal instructions.
排除标准
- •The exclusion criteria were mental retardation diagnosis, additional treatment other than neurodevelopmental treatment (NDT), surgical intervention or Botulinum Toxin injection in the last six months, diagnosis of psychiatric disorder accompanying CP, vision and/or hearing problems affecting participation.
结局指标
主要结局
Gross Motor Function Classification System (GMFCS)
时间窗: 15 minutes
The GMFCS was used for classify motor functions of participants. The GMFCS consisted five levels from 1 to 5, level 1 is the most independent whereas level 5 is fuly dependent. The Turkish GMFCS is valid and reliable.
Pediatric Evaluation of Disability Inventory (PEDI)
时间窗: 30 minutes
It was used to evaluate functional performance and disability level.PEDI contains 3 scales : Functional Skills Scale (FSS) that identifies clinical patterns of current skills in functional skill attainment; Caregiver Assistance Scale that indirectly measures capability and evaluates actual performance by assesing the extent of help a parent provides in daily functioning, and Modifications scale which was not used in current study. The FSS consists of self-care, mobility, and social function, including the ICF's activity and participation. It consist 197 items in total devided as 73 items in self care, 59 items in mobility and 65 items in social function. Each item is scored as unable (0) or able (1). The caregiver assistance scale measures the caregiver support with a Likert-type rating (0-5). PEDI is sensitive to show clinical changes that can guide the therapist in defining the functional level of children with CP (21-22). The Turkish validity and reliability was established (22).
The Canadian Occupational Performance Measure (COPM)
时间窗: 30 minutes
It was used to identify children's occupational problems and determine the goals of play. The COPM is a patient-reported, semi-structured assessment for individuals aged 8 years and over; it is used for goal-setting and planning interventions (18). The participants who were older than 8 years were asked to answer by themselves, and participants who were under 8 years answered both by themselves and parent proxy to identify and score occupational performance problems experienced in self-care, productivity, and leisure. In comparing initial and final values, a change of at least 2 points indicates clinical significance (19,20). The Turkish validity and reliability was established by Torpil et al (20).
Manual Ability Classification System (MACS)
时间窗: 15 minutes
The MACS was used for classify manuel functions of participants. The MACS consisted five levels from 1 to 5, level 1 is the most independent whereas level 5 is fuly dependent. The Turkish MACS is valid and reliable.
次要结局
未报告次要终点
研究者
Ruya Gul Temel
Occupational Therapist
Hacettepe University