NCT01208142终止不适用
Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Change in plantar flexion while ambulating
研究概览
简要总结
The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers.
For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynaslint worn at night.
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
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Toe Walking secondary to CP
- •Idiopathic TW
- •Inability to ambulate with initial heel-contact
- •Inability to bear weight and stand flat-footed for over one minute
- •Inability to stand or hop on one foot (symptomatic) for more than one minute
排除标准
- •Acid Maltase Deficiency Myopathy
- •Acute Paralytic Poliomyelitis
- •Spinal Muscular Atrophy-all types
- •Stroke, ischemic or hemorrhagic, all types
- •Multiple Sclerosis
- •Traumatic Brain Injury (including Shaken Baby Syndrome)
- •Unilateral ROM deficits in Knee or Hip
- •Previous Achilles Tendon lengthening surgery
- •Hemiplegic Cerebral Palsy
- •Muscular Dystrophy-all types
结局指标
主要结局
Change in plantar flexion while ambulating
时间窗: 12 weeks
The primary endpoint or dependent variable of this study will be the change in excessive plantar flexion while ambulating. A repeated measures analysis of variance (ANOVA) will be performed to measure kinematic change in gait patterns calculated with an ambulation laboratory test.
次要结局
未报告次要终点
研究者
研究点 (4)
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