Comparative Efficacy Research of Intensive and Distributed Constraint-Induced Therapy: Evidence-Based Neurorehabilitation in Children With CP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- "change" Melbourne Assessment 2 (MA2)
研究概览
简要总结
This 3-year research project aims to investigate and compare the treatment effectiveness (in terms of motor and psychosocial outcomes) and potential predictors (in terms of demographical, biological and psychosocial domains) of the intensive and distributed Child- and Family-Friendly CIT protocols with an equivalent intervention period in children with CP by quasi randomized controlled study design. In addition, the selection and examination of outcome measures were based on the ICF-CY model to provide comprehensively documents.
详细描述
Upper limb dysfunction is a common and disabling consequence of children with cerebral palsy (CP). As children with hemiplegia primarily have one better funcitoning side of their body and one more affected side, they often tend not to use the affected extremity resulting in the phenoema of developmental disregard. Recent evidence suggests that constraint-induced therapy (CIT) is the most effective technique to improve the use of the affected hand and reduce the developmental disregard in children with CP. However, despite the cumulative evidence supporting the effects of pediatric CIT, the concerns of feasibility and gaps of current knowledge prompt us to conduct this current proposal. The concerns of the feasibility include this approach is emotionally problematic at early stages and researchers suggested that the orginal CIT protocols may be too intrusive for children and their families. The gaps of current knowledge include: no study has directly investigated the effectiveness differences between various CIT models; no study examines, monitors and compares the psychosocial outcomes while receiving the CIT protocols for children and their parents systematically and comprehensively; and no study investigates the possible clinical characteristics of children that may influence the training effects of the various CIT models.
Investigators will recruit a total of 60 children with CP from the CP Association, medical centers, and special educational systems and participants will be assigned to the two intervention groups. The intensive CIT is delivered by the group-based design with 6 hours a day for 6 days (36 hours in total) and the distributed CIT will be delivered by individualized home-based intervention with 2.25 hours a day, two times a week, for 8 weeks (36 hours in total).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intensive CIT Model Program
In day camp model, the therapist will monitor and modify the activities to fit each child's ability and need (e.g. implementing task analysis, grading the challenge for each individual with varying capabilities) to make sure the intervention quality is equivalence to the individualized treatment.The day camp model will be arranged as "Adventure Camp" that decorating the treatment place as the adventure world and the participants take role as a warrior. This novel design is mean to enhance and motivate the engagement of participation.
干预措施: Intensive CIT Model Program (Other)
Distributed CIT Model Program
All treatment activities will be focused on the training of the more affected upper limbs with contextual restraint. Investigators choose this child-friendly way to restraint children's non or less impaired hand without any devices. Investigators will provide a unilateral activities and verbal cues to restraint participants' non or less affected side. All tailored activities will be designed as fun and age-appropriated based on the child's preference and parents' concerns. In order to help children to generalize the therapeutic gains to the real world environment, the intervention will take place in the natural environment such as home or school where it may be easier to identify real practical problems and makes the family or caregivers involved more closely and directly.
干预措施: Distributed CIT Model Program (Other)
结局指标
主要结局
"change" Melbourne Assessment 2 (MA2)
时间窗: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months
The MA2 was developed to investigate the objective upper-limb movement in children with CP aged 2.5 to 15 years (Randall, Imms, Carey, \& Pallant, 2014). The test comprises 14 functional tasks (e.g., grasping a pellet, pointing, and etc), which are representative of the most important components of unilateral upper limb function, including reach, grasp, release, and manipulate.
"change" Pediatric Motor Activity Log-Revised (PMAL-R)
时间窗: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months
The PMAL-R is adapted from the Pediatric Motor Activity Log (Taub et al., 2004), which was developed as an outcome measure for evaluating the effectiveness of CIT in children with CP. It is a parent-reported evaluative tool used to capture the spontaneous use of the affected upper limb in 22 daily activities. Each activity is rated by parents/careers on two set (how often and how well) of 6-point ordinal scales (0-5). The 'how often' scale measures amount of use, and the 'how well' scale measures quality of movement, of the affected upper limb. The PMAL-R testing manual is available online.
"change" Box and Block Test (BBT)
时间窗: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months
The BBT assesses manual dexterity by county the number of blocks that are transferred with a single hand from one compartment to another within 60 seconds. In recent years, it has increasingly been used to assess gross manual dexterity of the affected versus the non-affected hand in children and young adolescents with hemiplegia cerebral palsy.
次要结局
- "change" Motion Analysis(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)
- "change" ABILHAND-Kids(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)
- "change" Test of Playfulness (ToP)(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)
- "change" Client Satisfaction Questionnaire (CSQ)(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)
- "change" Dimensions of Mastery Questionnaire (DMQ)(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)
- "change" Pediatric Engagement Questionnaire (PEQ)(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)
- "change" Parenting Stress Index-Short Form (PSI-SF)(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)
- "change" Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)
- "change" Pediatric Evaluation of Disability Inventory (PEDI)(Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months)