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临床试验/NCT06507631
NCT06507631已完成不适用

Feasibility and Effectiveness of the Blended Care Pirate Group for Children With Unilateral Cerebral Palsy

Sint Maartenskliniek2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Training hours

研究概览

简要总结

Rationale: In 2010 Aarts developed the pirate group in which children received constrained induced movement therapy (constrained with a sling) followed by bilateral therapy. During this pirate group children were dressed as a pirate to increase motivation and to make the sling more meaningful. This pirate group had a duration of eight weeks with three times three hour training sessions each week. However, due to COVID-19 therapists were introduced to home-based rehabilitation. Therefore they developed the blended care pirate group, which is in principle the same as the pirate group of Aarts, however one training session each week is replaced by a home-based training session. It is however not yet clear how this blended care pirate group is perceived by parents and therapists.

Objective: The aim of the current study is to investigate the feasibility and effectiveness of the blended care pirate group.

Study population: Children with unilateral cerebral palsy between 2.5 and 8 years old will participate. These children will participate in the blended care pirate group and are asked to participate in the study as well.

Intervention: The total duration of one blended care pirate group is eight weeks with two times three hour training sessions at the rehabilitation centre and additional training sessions at home. The training sessions on-site will be the same as the conventional pirate group. For the training sessions at home parents will receive instructions and material from the therapists. This intervention is developed and already planned by therapists without direct influence of the research department and can therefore be considered as standard treatment.

Main study parameters/endpoints: The primary outcome are the total training hours performed by parents at home. Additionally after the blended care pirate group parents and therapists will participate in an interview about how they perceived the blended care pirate group. Secondary outcomes are improvements in arm function during the blended care pirate group.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
30 Months 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Receiving treatment at the Sint Maartenskliniek. Care demand of parents that requires a more and better use of the affected arm and hand.
  • Children with unilateral cerebral palsy
  • A Manual Ability Classification System (MACS) score of I, II or III

排除标准

  • Cognitive developmental age below 2
  • Child is not able to walk independently without a walking tool

结局指标

主要结局

Training hours

时间窗: During the 8-week intervention period

Training hours at home will be logged by parents. The total training hours will be compared to the advised training duration of three hours per week.

次要结局

  • Assisting Hand Assessment (AHA)(Before and after 8-week intervention)
  • Interview with parents(After the 8-week intervention period)
  • Box and Block test (BBT)(Before and after 8-week intervention)
  • Video observarion Aarts en Aarts - Determine Developmental Disregard - Revised (VOAA-DDD-R)(Before and after 8-week intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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