Conventional Physiotherapy Versus Use of a New Ankle Trainer Device After Weber b Ankle Fracture Operation. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 主要终点
- Olerud Molander ankle score (OMAS)
研究概览
简要总结
The study will compare the functions outcomes between two different rehabilitation protocol after operated weber b ankle fractures
详细描述
Patients that are operated for weber b ankle fractures will after the surgery be randomized into two different post operative rehabilitation protocols. One group will receive conventional physiotherapy with stretching of the ankle with a non-elastic band, while the other group will use a new spring-loaded ankle trainer. The rehabilitation will continue for 3 weeks. Patients will be evaluated with the Olerud Molander ankle score and visual analog scale for pain at 3, 6, 12 and 52 weeks follow-up. Length of hospitalization and all adverse events will be registered. Ankle range of motion will be registered at 6, 12 and 52 weeks
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The physiotherapist conducting follow ups at 6, 12 and 52 weeks was masked for group affiliation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weber b ankle fracture. Exercise stable osteosynthesis. Good compliance
排除标准
- •Previous trauma to the tibia or fibula. Previous ankle or foot surgery. Sympthomatic arthritis or generalized joint disease
结局指标
主要结局
Olerud Molander ankle score (OMAS)
时间窗: 52 weeks after surgery
A patient related outcome measure that evaluates ankle function on a 0-100 scale. 100 is indicating a perfect result
次要结局
- Ankle range of motion(52 weeks)
- Visual analog scale for pain (VAS)(52 weeks)
研究者
Marius Molund
Principal investigator
Oslo University Hospital