Effects of Walking Analysis on Surgical Outcomes
Impact of Gait Analysis on Surgical Outcomes
研究概览
详细说明
Gait analysis testing has been used to assist orthopaedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. Previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. However, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. Consequently, the use of gait analysis in clinical practice remains controversial. The purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy.
Comparison: Surgery with information from gait analysis testing compared with surgery without information from gait analysis testing.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
California
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Los Angeles、California、美国、90027
- Childrens Hospital Los Angeles
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Los Angeles、California、美国、90020
- Shriners Hospital for Children, Los Angeles
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of cerebral palsy
- Able to walk
- Under evaluation for orthopedic surgery to correct walking problem(s)
Exclusion Criteria:
- Orthopaedic surgery in past 1 year
- Injection of botulinum toxin in past 6 months
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Gait analysis
Gait analysis report is available for treatment planning
|
Orthopaedic surgery with access to gait analysis report
|
有源比较器:Control
Subject has gait analysis test, but report is not available for treatment planning
|
Orthopaedic surgery without access to gait analysis report
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Change in walking ability at 1 year
大体时间:1 year
|
1 year
|
Change in walking efficiency at 1 year
大体时间:1 year
|
1 year
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Change in gross motor function at 1 year
大体时间:1 year
|
1 year
|
Change in quality of life at 1 year
大体时间:1 year
|
1 year
|
Additional treatment needed at 1 year
大体时间:1 year
|
1 year
|
合作者和调查者
调查人员
- 首席研究员:Tishya AL Wren, Ph.D.、Children's Hospital Los Angeles
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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