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临床试验/NCT03166293
NCT03166293已完成不适用

Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia From Encephalopathy of Prematurity

University of Alberta3 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年6月1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
4
试验地点
3
主要终点
Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months

研究概览

简要总结

This is a randomized controlled trial comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of motor function in the legs in young children with spastic diplegia.

详细描述

Children born prematurely are at risk of brain injury that can result in cerebral palsy(CP), most often affecting the legs, called spastic diplegia. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (Botox) in muscles that are abnormally active, and surgery as deformities occur. Active, physical therapy for weak muscles is infrequent, occurring twice a month or less. Yet, recent work with mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young. Building on the success with early, intensive therapy for children with perinatal (around birth) stroke, the investigators will apply intensive therapy for the legs in children with diplegia. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 3 mo. The delay period controls for improvement without treatment. These children will also receive treatment after the delay period. The therapy will be guided by physical therapists, and similar to the project on perinatal stroke. Children who live beyond commuting distance from the centres will form a 3rd group, whose parents will be coached by therapists to train the child at home. This group will show whether parents can be as effective as a therapist. Finally, when all children turn 4 yr old, they will be compared to other 4-yr-old children with the same diagnosis, but no training, to determine if there are long term benefits. The investigators anticipate that like the children with perinatal stroke, early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 8 mo - 3 yr old
  • Evidence of periventricular white matter injury on diagnostic imaging
  • clinical evidence of spastic diplegia

排除标准

  • born before gestational age of 25 weeks
  • birth weight <1000g (to exclude confounds related to extreme prematurity and low birth weights)
  • MRI evidence of diffuse injury to the cerebral or cerebellar cortex
  • uncontrolled epilepsy or infantile spasms in the past 6 months (contraindication for TMS)
  • cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
  • Botulinum toxin (BTX-A) injections in the last 6 months
  • Predicted GMFCS 4 or 5

结局指标

主要结局

Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months

时间窗: Baseline, 3 months

This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy.

次要结局

  • Change in forces during treadmill walking over 3 months(Baseline, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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