跳至主要内容
临床试验/NCT05106114
NCT05106114已完成不适用

Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level Surgery in Cerebral Palsy

Fondation Ellen Poidatz2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年5月28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
23
试验地点
2
主要终点
6-minutes walking test

研究概览

简要总结

In the context of cerebral palsy, rehabilitation post Single-Event Multi-Level Surgery (SEMLS) is a long process. One year after surgery and rehabilitation, the functional benefits are usually less improved than the gait pattern. This may be caused by a lack of intensity in the final rehabilitation steps. Thus we created an intensive gait training rehabilitation protocole. This protocole associates 4 weeks of intensive rehabilitation in a healthcare center followed by 2 weeks of intensive rehabilitation at home. The objective of this study is to evaluate the efficiency of this protocol to improve walking speed and endurance, gross motor function et muscular strength.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Cerebral palsy
  • Age between 10 and 20 years
  • Single-Event multi-level surgery more than one year ago
  • GMFCS I to III
  • Capacity to understand simple instructions
  • Volontary consent

排除标准

  • injuries or pain in lower limbs
  • toxines or surgery less than one year before the study

结局指标

主要结局

6-minutes walking test

时间窗: 15 minutes

Evaluation of walking speed

次要结局

  • Gross Motor Function Measure (GMFM)(30 minutes)
  • Shuttle Run test-I and II(10 minutes)
  • 10 meters walking test(5 minutes)
  • Muscle strength via a Dynamometer(15 minutes)
  • Pediatric Quality of Life Inventory (PedSQL)(10 minutes)
  • Spatio-temporal gait parameters(45 minutes)
  • Number of steps per day(one week wearing an accelerometer)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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