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临床试验/NCT07469514
NCT07469514尚未招募不适用

CIRCLE-CP Study: Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT/OT Caregiver "Primer" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
1
主要终点
Caregiver knowledge, comfort, and confidence

研究概览

简要总结

This study focuses on the caregiver's knowledge, comfort, and confidence in interacting with and supporting their infant with Cerebral Palsy (CP) or at high risk for Cerebral Palsy. Four caregivers with their infants will be in one cohort to assess the benefits of group intervention. The intervention is delivered in a group, bootcamp-style educational format led by clinical team including pediatric physiatrist, physical therapist and occupational therapist.

详细描述

This program aims to provide caregivers with structured education and practical skills related to early intervention of cerebral palsy. Session content includes: (1) understanding the definition and nature of cerebral palsy; (2) the importance of early intervention and principles of infant neuroplasticity; and (3) foundational early motor strategies and CP-specific therapeutic principles commonly used in PT and OT. Sessions incorporate therapist demonstration, caregiver coaching, and guided motor play with the infant. In addition to knowledge-building, the intervention also aims to provide intentional caregiver support following the early diagnosis of CP, and achieves this via fostering peer support among families with similar experiences, and empowering caregivers in navigating and advocating within their child's early intervention system. Outcomes will be assessed through pre- and post-intervention parental Likert-scale surveys measuring (1) caregiver perceived knowledge, comfort, and confidence interacting with their infant, (2) perceived benefit of the group program, and (3) caregiver readiness to actively engage in ongoing longitudinal CP-specific early intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Months 至 15 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants 3-15 months corrected age at enrollment
  • Diagnosed with CP or at high possibility of CP
  • Not yet independently walking at baseline
  • Medically stable for therapeutic handling and group play
  • Primary caregiver (>=18years) able to attend all weekly group sessions
  • English-speaking only

排除标准

  • Unstable medical condition (eg, frequent desaturations, emeses, uncontrolled seizures) or acute restrictions incompatible with participation
  • Concurrent enrollment in another intensive motor program
  • Profound sensory impairments that preclude group program participation

研究组 & 干预措施

Caregiver-Infant

Other

干预措施: Physical therapy (Behavioral)

Caregiver-Infant

Other

干预措施: Caregiver knowledge (Behavioral)

Caregiver-Infant

Other

干预措施: Occupational Therapy (Behavioral)

结局指标

主要结局

Caregiver knowledge, comfort, and confidence

时间窗: Baseline to 6 weeks.

Change from baseline in caregiver-perceived knowledge, comfort, and confidence in interacting with and supporting their infant with CP or high CP risk trhough integrated PT/OT caregiver-focused group intervention at 6 weeks.

次要结局

  • Early Start(Baseline to 6 weeks.)
  • Group intervention(Baseline to 6 weeks.)
  • Feasibility of Groups(Baseline to 6 weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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