Outcome of Patients After Lower Limb Fracture With Partial Weight Bearing Postoperatively Treated With or Without Anti-gravity Treadmill (Alter G®) During Six Weeks of Rehabilitation - a Bicentric Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- Change of overall KOOS or FOAS
研究概览
简要总结
The presented study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau or ankle fractures with six weeks of partial weight bearing.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a postoperative partial weight bearing after tibial plateau or ankle fracture.
- •man and woman of an age between 18 and 65
排除标准
- •Body weight more than 100kg
- •serious illness or poor general health as judged by physician that may influence the rehabilitation
- •open fractures (>1° according to Gustilo and Anderson)
- •surgical site infection
- •pregnancy
- •neuromuscular disorders or preexisting muscle atrophy.
研究组 & 干预措施
anti-gravity treadmill arm
Treatment with anti-gravity treadmill (alter G®)
干预措施: anti-gravity treadmill (alter G®) (Other)
control arm
Treatment with standardized physiotherapy
干预措施: standardized physiotherapy (Other)
结局指标
主要结局
Change of overall KOOS or FOAS
时间窗: 12 months
Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score) or FOAS (Foot and Ankle Outcome Score) from baseline (Day 1 after operation) to Final Assessment (FA) 12 months after operation determined for each group and between the groups.
次要结局
- Change of the 5 subscores of the KOOS or FAOS(Baseline to 6 and 12 weeks and 12 months)
- Circumference measurement of tights and lower leg on both legs(Baseline to day of discharge, 3,6 and 12 weeks and 12 months)
- ROM(Baseline to 6 and 12 weeks and 12 months)
- SF-36(Baseline to 6 and 12 weeks and 12 months)
- DGI(day of discharge to 3, 6 and 12 weeks and 12 months postoperative)
研究者
Dr. med. Ralf Henkelmann
Dr. med. Ralf Henkelmann
University of Leipzig