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临床试验/NCT01335100
NCT01335100Unknown不适用

Does Botulinum Toxin Injections Improve Outdoor Activity in Children With Cerebral Palsy?- a Pilot Study

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
outdoor activity

研究概览

简要总结

Background:

Motor impairment limits social and recreational activities in children with cerebral palsy (CP), compromising participation and impacting on quality of life. Improvement of motor function by medical treatment may advance in participation of outdoor activities and expand social and recreational activities. While Botulinum toxin (BTX) injections are effective and safe treatment for spasticity in children with CP, there is insufficient evidence for improvement of motor function and enhanced participation in this population.

Objective:

To examine outdoor activity as a functional outcome following lower limb BTX in children with CP.

Methods:

In this pilot study the investigators will use Global Positioning Systems (GPS) to measure walking speed, distances, number of walking events and destinations in ambulatory children with CP following BTX injection to the lower limbs; age and gender matched sibling will be studied as a control group. Outdoor activity will be measured at 1, 3 and 6 months following BTX treatment will be compared to baseline and to those of siblings. Outdoor activity will be correlated with leisure activity preferences and quality of life questionnaires.

Significance: Improvement in outdoor activity following BTX injections in this pilot study will assist construction of a larger study evaluating participation and quality of life in children with CP.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ambulatory children with CP following BTX injection to the lower limbs

排除标准

  • significant psychomotor retardation, psychiatric symptoms or behavioral problem that may impact on outdoor activity prefernces

结局指标

主要结局

outdoor activity

时间窗: 9 months

次要结局

  • leisure activity preferences and quality of life(9 months for the pilot)

研究者

申办方类型
Other

研究点 (1)

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