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临床试验/NL-OMON36506
NL-OMON36506已完成不适用

The efficacy of night splinting in children with cerebral palsy, a randomised controlled trial - Splint

Vrije Universiteit Medisch Centrum0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
2 至 17(—)

入选标准

  • They have a clinical diagnosis of unilateral or bilateral spastic CP
  • They have an age between 4-12 years old
  • They have a range of motion in the ankle of 0º plantar flexion or less with an extended knee, tested by a clinician with a manual force.
  • They are able to walk with or without aids (GMFCS class 1-3).
  • They have a range of motion in the ankle less than 5º with an extended knee, tested by the clinician with reasonable manual force and will be treated with:
  • * Botulinum toxin A injections in the m. Gastrocnemius
  • * AND/OR serial casting
  • * AND/OR orthotic management in rest with a Knee-Ankle-Foot-Orthosis
  • o OR they have a range of motion in the ankle less than 20 degrees and more than 0 degrees dorsiflexion and they have been treated for a decreased range of motion (defined as less than 5 degrees dorsiflexion) in the ankle in the past by:
  • * Botulinum toxin A injections in the m. Gastrocnemius (at least 6 months ago)
  • * AND/OR serial casting (at least 3 months ago)
  • * AND/OR orthotic management in rest with a Knee-Ankle-Foot-Orthosis
  • They live in a stable social family situation.

排除标准

  • Surgery of the Gastrocnemius and/or Soleus muscle has been performed in the past.
  • A Selective Dorsal Rhizotomy has been performed in the past
  • There is administration of treatment of Intra Thecal Baclofen therapy
  • The cannot extend their knees fully.
  • They have behavioural problems or sleeping problems.
  • The child is institutionalized.
  • There is co-morbidity interfering with mobility.
  • Parents/guardians and/or child do not understand the Dutch or English language well enough to take part in this project

研究者

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