Motor Training Intervention for Infants at High-Risk for Cerebral Palsy: Feasibility and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up
研究概览
简要总结
The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.
详细描述
The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "Let's Move" delivered using a combined clinic and home (video telehealth) therapy model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at enrollment: between 3-8 months corrected age
- •Caregivers fluent in English
- •Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR
- •High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:
- •"Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR
- •A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)
排除标准
- •Medical conditions that restrict active participation such as oxygen dependence
- •Infants with significant visual deficits defined by the inability to track an object horizontally
- •Living in a remote location prohibiting drives to the hospital every other week.
研究组 & 干预措施
Control group
Infants randomized to the usual care arm will receive usual care for 4 months. Therapy services provided to infants at this age vary in terms of frequency, location, and provider. Usual care is prescribed by the child's primary care provider (PCP), and in this population, usual care typically consists of one or both of the following: Early intervention therapy services provided by the state or Therapy in an outpatient clinic. Control group participants will be offered the Let's Move interventions after 16 weeks of control group.
干预措施: Let's Move Motor Intervention (Other)
Intervention group: Let's Move
Infants randomized to the Let's Move intervention group will be scheduled for therapy one time per week for 16 sessions (approximately 30-60 minutes per session). The intervention setting will involve both in-person (CCHMC clinic or in-home) and telehealth (in-home, video-based) sessions. The therapist will provide the caregivers with home programs to complete between therapy sessions (5 days per week). The home program will be based on the infant's goals set collaboratively between the caregiver and the evaluating therapist at the baseline assessment using the Canadian Occupational Performance Measure (COPM). At least half of the intervention sessions will be video recorded to assess feasibility and monitor intervention fidelity.
干预措施: Let's Move Motor Intervention (Other)
结局指标
主要结局
Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up
时间窗: Baseline,16 weeks, 28 weeks
Motor test
次要结局
- Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up(Baseline,16 weeks, 28 weeks)
- Change on Canadian Occupational Performance Measure before and after intervention and follow-up(Baseline,16 weeks, 28 weeks)
- Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up(Baseline,16 weeks, 28 weeks)
- Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up(Baseline,16 weeks, 28 weeks)
- Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up(Baseline,16 weeks, 28 weeks)
- Change on Canadian Occupational Performance Measure before and after intervention and follow-up(Baseline,16 weeks, 28 weeks)
- Preverbal visual assessment (PreViAs(Enrollment, 4 months later, 8 months later)
研究者
Karen Harpster
Associate Professor
Children's Hospital Medical Center, Cincinnati