NCT01586390已完成2 期
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Functional scores according to Karlsson score
研究概览
简要总结
In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials.
Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 2 and 3 acute ankle sprains
排除标准
- •history of ankle sprains with persistent instability
- •grade I lateral ankle sprains
- •ankle fracture
- •bilateral ankle sprains
- •previous ankle ligament surgery
- •neuromuscular disorders of the lower extremities
- •rheumatoid arthritis,
- •alcoholism,
- •serious psychiatric or neurological illness
结局指标
主要结局
Functional scores according to Karlsson score
时间窗: Follow-up of 4 months
The modified KSS gives a score from 0-90 on perceived function of the ankle and foot, divided over eight topics relevant to daily function. The modified KSS at 4 months was the primary endpoint.
次要结局
- Pain(follow-up of 4 months)
- Satisfaction score(follow-up of 4 months)
研究者
研究点 (2)
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