NL-OMON36506已完成不适用
The efficacy of night splinting in children with cerebral palsy, a randomised controlled trial - Splint
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
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