Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delays
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 75
- 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 purpose of this study is to determine the optimal frequency and intensity of physical therapy for children with cerebral palsy aged 6 to 24 months of age. Participants will be randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy. Short and long term effects will be evaluated to determine the best 'dose' of rehabilitation for children with cerebral palsy, including frequency (number of sessions per week and the number of weeks), intensity (how hard the patient works), and time (how many total hours) of rehabilitation treatment.
详细描述
Determining optimal frequency of treatment for young children with cerebral palsy (CP) has implications for shaping the future of pediatric rehabilitation. There are wide variations in the number of hours per week of treatment in current outpatient rehabilitation programs for children with CP, suggesting clinical uncertainty. Usual weekly therapy at 1 - 2 hours per week for 6 months or longer is the most commonly implemented frequency of dose for children with CP 6 - 24 months of age. However, this decision about frequency is often made based on clinical reasoning and scheduling, not on principles of rehabilitation, child development, or evidence from strongly designed randomized controlled trials. The proposed study will fill this gap by directly comparing the effects of 3 frequency levels of therapy - concentrated daily, intermediate, and usual weekly in children with CP 6 - 24 months of age at the initiation of treatment and following these patients for 2 years.
In this prospective longitudinal study, children with Cerebral Palsy (n=75), 6 - 24 months of age, will be randomly assigned to one of three groups: daily, intermediate, or weekly physical therapy. The treatment phase of this study design is 5 months for a total of 40 hours of one-on-one therapy for both groups. Level 1 daily therapy is 2 hours of therapy per day for 20 straight weekdays. Level 2 intermediate therapy is 2 hours of therapy per day 3 days per week for 6.6 weeks. Level 3 usual weekly therapy is 2 hours of therapy one day per week for 20 weeks. Researchers will directly compare the effects of 3 these frequency levels of therapy at the initiation of treatment and following these patients for 2 years. Results will provide quantitative evidence of frequency-response, which is critical for informing clinical decision-making, health policy, and guidelines for reimbursement.
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
- 6 Months 至 24 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an age of 6 months - 24 months at the initiation of treatment. The age will be corrected for any eligible children born preterm until they are 2 years of age, as is standard clinical and research practice
- •a diagnosis or risk for CP in GMFCS levels III, IV and V or motor delay
- •ability to tolerate a 2 hour therapy session based on parent report and evaluating therapists, the same criteria the investigators used for the pilot study.
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.
结局指标
主要结局
Change in Gross Motor Function Measure (GMFM)-88
时间窗: Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment
GMFM evaluates change in gross motor function over time or with intervention in children with CP from 5 months to 16 years. It has been used widely in the field to determine functional motor change following intervention.
次要结局
- Change in Goal Attainment Scaling (GAS)(Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment)
- Change in Bayley Scales of Infant Development III(Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment)
- Change in Pediatric Evaluation and Disability Inventory (PEDI)(Baseline (pre-treatment) and 3 months, 6 months, 12 months, 18 months, and 24 months after initiation of treatment)
研究者
Jill Heathcock
Assistant Professor
Ohio State University
