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临床试验/NCT05346887
NCT05346887已完成不适用

Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

University of Calgary2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Satisfaction of therapists

研究概览

简要总结

The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.

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 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • aged three to 24 months (corrected, if premature)
  • clinician-identified hand asymmetry
  • suspected/confirmed cerebral palsy (hemiplegia or triplegia)
  • willing to withhold other formal upper-limb focussed treatment during the study intervention - willing to commit to completing 18 weeks of daily home-practice and attending weekly therapy sessions.

排除标准

  • participation in formal constraint induced movement therapy (CIMT) within last six months
  • upper limb botulinum toxin A injections within previous six months
  • brachial plexus injury
  • lower motor neuron dysfunction
  • upper limb congenital limb difference.

研究组 & 干预措施

Home-based Therapy

Experimental

干预措施: Home-based Therapy (Behavioral)

结局指标

主要结局

Satisfaction of therapists

时间窗: <7 days after the 18-week intervention

Satisfaction with the intervention will be assessed using a study-built questionnaire with Likert-scale response options 0 to 4, with 4 being greater satisfaction.

Canadian Occupational Performance Measure (COPM)

时间窗: <7 days after the 18-week intervention

Using the COPM, three to five individualized functional goals will be identified by caregivers and then scored on a scale of 1 to 10 for both Performance and Satisfaction.

Age-appropriate hand assessment (HAI/mini-AHA/AHA)

时间窗: <7 days after the 18-week intervention

The HAI/mini-AHA/AHA employ a video-recorded play-based session of \<15 minutes to provide a logit-based measure of manual function.

次要结局

  • Canadian Occupational Performance Measure (COPM)(8 weeks +/-3days after the the 18-week intervention.)
  • Age-appropriate hand assessment (HAI/mini-AHA/AHA)(8 weeks +/-3days after the the 18-week intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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