NCT01589679终止不适用
Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- A Repeated Measures Analysis of Variance (ANOVA)
研究概览
简要总结
To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis 1st MTJ Contracture following Bunionectomy
排除标准
- •Current treatment with Botulinium Toxin-A (Botox), lower extremity
- •Current treatment Fluoroquinolones (antibiotic medication)
- •Current use of muscle relaxant medications
- •Fibromyalgia
- •Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
- •Treatment with electrical stimulation assisting ambulation (i.e Bioness, WalkAide, Parastep, etc.)
结局指标
主要结局
A Repeated Measures Analysis of Variance (ANOVA)
时间窗: 12 months
ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).
次要结局
未报告次要终点
研究者
研究点 (6)
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