A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change in Gross Motor Function Measure (GMFM)-88
研究概览
简要总结
The ACHIEVE study is a comparison of the effectiveness of 2 intensities of physical therapy treatment for children with Cerebral Palsy in an outpatient physical therapy setting. High intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks. In comparison, usual weekly is considered standard of care; although both dosing models are used clinically for children with CP. Participants are assign to the treatment group at random. Participant who are unable to consent to randomization are allowed to chose a treatment group.
详细描述
The overall goal of this project is to compare the effectiveness of high intense periodic and usual weekly therapy in treating Cerebral Palsy (CP) in children 2-8 years of age for motor rehabilitation. In this prospective randomized controlled trial (RCT), 108 children ages 2 to 8 years of age with CP will be enrolled and assigned to one of 2 service delivery models: 1 hour per day, 1 x per week for 40 weeks (usual weekly); and 2 hours every weekday for two 10-consecutive-weekdays (total 4 weeks), for a repeated "periodic" bout (high intense periodic). Participants unable to consent to randomization are allowed to chose a treatment group. All patients enrolled in ACHIEVE will also have 1 hour per month of Physical Therapy Consultation (PTC) during the treatment period of 40 weeks (9 months). PTCs provide monthly motor skill monitoring, consultation, and home therapy program progression. Outcome evaluations will be performed by blinded evaluators at baseline (month 0, before treatment), month 9 for all patients to assess short term effects, and at months 12 and 18 for patients to assess long term effects. Parent surveys will be collected at 0, 4.5, and 9 months only (PC-2). Short-term and long-term effects will be analyzed to determine individual differences in children's response to intensity. A subset will be analyzed at 12 and 18 month.
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
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 to 8 years of age at initiation of treatment
- •a diagnosis of motor delay or CP in GMFCS levels 1-V
- •ability to tolerate a 2 hour therapy session based on parent report and evaluating therapists.
排除标准
- •uncontrollable seizures or any co-morbid condition that prevents full participation during treatment sessions
- •participation in another daily treatment program in the last 6 months
- •auditory or visual conditions that prevent full participation during treatment sessions
- •Progressive neurological disorder with no potential for improvement.
- •Recent surgery where physical therapy is contraindicated.
结局指标
主要结局
Change in Gross Motor Function Measure (GMFM)-88
时间窗: Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.
GMFM evaluates change in gross motor function over time or with intervention in children
次要结局
- Change in Pediatric Evaluation and Disability Inventory (PEDI)(Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.)
- Change in Bayley Scales of Infant Development III(Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.)
- Change in Goal Attainment Scaling (GAS)(Baseline (pre-treatment) and 9 months 12 months, and 18 months following initiation of treatment.)
研究者
Jill Heathcock
Associate Professor
Ohio State University