Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 8
- 主要终点
- Change in sitting behavior
研究概览
简要总结
The purpose of the proposed project is to compare the efficacy of two fully developed physical therapy interventions in 8-24 months olds with or at high risk of having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments.
详细描述
The purpose of the proposed project is to compare the efficacy of two fully developed physical therapy interventions in 8-24 months olds with or at high risk of having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments. The project builds on a nearly complete clinical trial evaluating the efficacy of the START-Play intervention compared to a non-dose matched comparison group. The proposed study directly addressed the need for a dose-matched clinical trial to consider the impact of dose of intervention on efficacy. A direct comparison of START-Play with the dose matched (24 visits in 3 months) UCPT provided in the same environment (homes) and provided by licensed physical therapists will allow for a direct comparison of the efficacy of interventions based on two different set of key principles.
START-Play is based on developmental and basic science, motor learning, and neuroplasticity, in addition to our extensive preliminary efficacy data. START-Play has been fully described with a protocol manual, training documents, and fidelity measures. The UCPT intervention is based on videotaped session of the comparison group community based intervention sessions and parent report for the ongoing clinical trial. A fidelity measure used the previous research quantifies differences in the focus of these interventions and will be used to maintain adherence to both intervention groups. Three sites in different regions of the United States will recruit from local intervention and medical centers for a total of 150 infants with or at high risk of having cerebral palsy between ages 4-24 months of age, when they show readiness skills for early sitting and reaching. Risk for CP will be based on the early detection guidelines and all outcome measures are included in the NIH supported Common Data Elements for Cerebral Palsy. Each infant will be randomized into a group and will receive the START-Play or the UCPT intervention for 3 months, with follow up extending for 12 months from baseline.
The primary objectives examine change over time in sitting gross motor and cognitive development.
Differences in outcomes between the two intervention groups will be examined. In addition, we will begin to identify predictors of response to developmental motor interventions by evaluating the relationship between intervention outcomes and 1) infant and family characteristics, 2) presence of white matter, cerebellar, basal ganglion, or gray matter injury.
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)
盲法说明
outcome assessor is blinded to group assignment.
入排标准
- 年龄范围
- 8 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dx or clinical signs of cerebral palsy (CP) previously described
- •Between 8-24 months of age (corrected for prematurity as applicable) at study entry
- •Able to prop sit for 3 seconds, maintain the head at least to the level of neutral alignment with the trunk supported at the axilla, exhibit some spontaneous movement of the arms and visually focus on a toy or person's face for at least 3 seconds in any position.
- •Gross motor delay with a Bayley IV gross motor subscale score less than 5.5 (1.5 standard deviation below mean)
排除标准
- •Medical complications that severely limit assessments/intervention participation such as severe visual impairment, congenital/orthopedic anomalies that limit sitting or reaching, or uncontrolled seizures.
- •A child will be excluded if the parents report any of following: 1) disability of a progressive nature such as muscular dystrophy or leukodystrophy; 2) family plans to move out of the local area within one year from the start of the study; 3) major surgery planned that might affect physical performance. 4) genetic conditions that have a similar presentation to intellectual disability or autism.
研究组 & 干预措施
START-Play Intervention
Sitting Together And Reaching to Play is an intervention designed to work on motor-based problem-solving. Thus the activities keep thinking skills at the forefront while also working on advancing motor skills. When initially developed to work with children who were emerging sitters the motor tasks focused on sitting and reaching resulting in the name.
干预措施: START-Play Physical Therapy (Behavioral)
Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical Therapy
This intervention was based on the observations of usual care from a previous study. Key principles included the use of Movement, Orientation, Repetition, and Exercise thus the intervention name was changed to MORE-PT before enrollment started. This reduced bias as the therapists and families were not informed this was usual care which could have biased them.
干预措施: Usual Care Physical Therapy (Behavioral)
结局指标
主要结局
Change in sitting behavior
时间窗: Baseline to the end of the intervention, up to 12 months
Sitting will be assessed using the sitting scale of the Gross Motor Function Measure (GMFM-88)
次要结局
- Change in gross motor skills(Baseline to the end of the intervention, up to 12 months)
- Change in Language(Baseline to the end of the intervention, up to 12 months)
- Change in fine motor skills(Baseline to the end of the intervention, up to 12 months)
- Change in Cognitive skills(Baseline to the end of the intervention, up to 12 months)
研究者
Stacey Dusing
Professor
University of Southern California