NEMEX-ATR: A Randomized Pilot Study on Early Neuromuscular Exercise in Non-surgically Treated Achilles Tendon Rupture
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Heel-raise
研究概览
简要总结
The purpose is to study the effect of early NEuroMuscular EXercise (NEMEX) versus conventional treatment (late exercise) in patients with acute non-operative achilles tendon rupture (ATR).
详细描述
There is currently no consensus on treatment for achilles tendon rupture with regard to surgical or non-surgical treatment. In addition, the optimal time to start exercise treatment after the injury, with or without surgery, is not well understood. Animal studies show positive effects of early mobilization in tendon healing. Neuromuscular exercise has shown better effects than strength exercise in people with knee injury or knee disease. There are few studies in humans focusing on exercise as treatment, without surgical intervention, after ATR.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 - 60 years.
- •The patient should before the achilles tendon rupture have been able to walk independently without aid, walk without limping, run/jog and be able to jump on one leg
- •The patient shall be able to read, understand and to assimilate the written information about the study.
排除标准
- •Previous achilles tendon rupture
- •Acute achilles tendon rupture, more than 5 days.
- •Medical restrictions regarding physical exercise, not related to the achilles tendon rupture
结局指标
主要结局
Heel-raise
时间窗: Week 16
Functional performance of calf muscles. The ability to perform a plantar flexion is assessed in a prone position at 1 and 4 weeks after the injury. At 8 and 16 weeks after the injury, the ability to perform a heel-raise standing on one leg is assessed.
次要结局
- Range of Motion(At weeks 1, 4, 8 and 16)
- 30-meters walk test(At weeks 8 and 16)
- VAS Pain(At weeks 1, 4, 8 and 16)
- Deep Venous thromboembolism(Weeks 1-16)
- Single limb standing balance(At weeks 4, 8 and 16)
- Single-limb mini squat(At week 16)
- The calf muscle circumference(At weeks 1, 4, 8 and 16)
- Foot and Ankle Outcome Score (FAOS)(At weeks 1, 4, 8 and 16)
- Short-Form 36 (SF-36)(At weeks 1, 4, 8 and 16)
- Re-rupture(Weeks 1-16)
- Modified Forward lunge from stairs(week 16)
- Physical Activity Level Scale(At weeks 1, 4, 8 and 16)
- Sick leave(Measured regularly from baseline until week 16)