Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches
试验速览
- 阶段
- 不适用
- 入组人数
- 18
研究概览
简要总结
This project (CO-OP II) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (CP). The initial study was comprised of a series of four single case studies with children with CP. It evaluated the potential of the Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children with CP and tested the procedures for CO-OP II. The overall objective of the full series of studies is to determine whether better functional outcomes are achieved for children with CP with CO-OP intervention than with contemporary occupational therapy treatment.
The primary objective of CO-OP II is to establish the feasibility of conducting a full scale randomize control trial (RCT) to discover if there are differences in functional outcomes (i.e., improvement in task performance, self efficacy) between a group of children with CP receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In order to meet this objective, a pilot RCT will be conducted to answer the specific research questions outlined below:
- Do children wiht CP acquire the skills they set as goals in each of the two treatment groups?
- Do the acquired skills generalize and transfer?
- Are the skills maintained at 4 months post intervention?
- Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy than the CTA?
- Does amount of parent involvement have any effect on skill acquisition or self efficacy?
Completion of this pilot RCT will provide the necessary data to conduct a full study to test the following hypothesis:
- Children with CP who receive CO-OP treatment will be more successful than children receiving CTA in improving their performance on child-chosen skills and they self efficacy.
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
- 7 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 7 and 12 years of age
- •diagnosis of cerebral palsy with hemiplegia or spastic diplegia
- •Level 1,2 or 3 on the Gross Motor Function Classification Scale(GMFCS)
- •normal intelligence (IQ> 85 on at least one scale (verbal or performance) of the Kaufman Brief Intelligence Test (KBIT-2)
- •child assent and agreement to participate
- •parental consent and agreement to participate
- •sufficient language ability to communicate with and be understood during treatment
排除标准
- •previously received or presently receiving a cognitive treatment for motor-based performance problems
- •use of alternative communication system such as PECS or communication board
- •regular use of BOTOX during intervention period
