Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- change from baseline elasticity modulus of the leg muscles at 4 weeks
研究概览
简要总结
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic Cerebral Palsy (CP). However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
Principal purpose of this study was to assess impact of night splint ankle foot orthoses on passive stiffness in plantarflexors muscles in children with CP.
详细描述
Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic CP. However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed spastic cerebral palsy
- •Children wearing night splint ankle foot orthoses all night long during 1 week minimum
- •Children with a level of spasticity in the gastrocnemius muscle greater than or equal to X1, VII, on the Tardieu scale and 2 on the Ashworth scale.
- •Children able to understand and respect the simple instructions of the study
- •Children and parents who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study.
排除标准
- •Children who do not tolerate ankle foot orthoses all night long.
- •Children who had botulinum injection in gastrocnemius or soleus muscles during last three months.
- •Children benefiting from an injection of botulinum toxin or the setting up of new equipment during the protocol.
- •Children who do not tolerate ankle foot orthoses all night long.
- •Children having benefited from plaster lengthening for less than three months.
结局指标
主要结局
change from baseline elasticity modulus of the leg muscles at 4 weeks
时间窗: Weeks 0, 1, 2, 3 and 4
measured by ultrasounds
次要结局
- Maximal dorsiflexion angle(Weeks 0, 1, 2, 3 and 4)
- Maximum angle of tense knee dorsiflexion(Weeks 0, 1, 2, 3 and 4)
- Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion(Weeks 0, 1, 2, 3 and 4)
- Visual Analog Scale of sleeping(Weeks 0, 1, 2, 3 and 4)