A Randomized Controlled Trial on the Effect of Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture. The Achilles Tendon Back-On-Track Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Achilles tendon total rupture score ATRS
研究概览
简要总结
The purpose of this trial is to investigate the efficacy of standard care versus standard care combined with an early progressive exercise program in improving the function of the tendon and leg muscles after non-surgical treated Achilles tendon rupture
详细描述
Acute Achilles tendon rupture often results in long-term muscular deficits. Patients struggle to return to work and sports with high load on the lower leg. Early functional rehabilitation has shown good results, but research on resistance exercise is scarce and the reporting of the specifics of the exercises are poor.
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)
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
- •Acute total Achilles tendon rupture treated non-surgically
- •Diagnosed within 3 days (of their injury)
- •Age 18 - 65, able and willing to participate in the intervention
- •Able to speak and understand Danish
排除标准
- •Achilles tendon rupture close to insertion on calcaneus or in the musculo-tendinous junction of the triceps surae
- •Previous Achilles tendon rupture or other conditions in either leg causing lower leg disability (pain, deficits in strength or range of movement)
- •Treated with Fluoroquinolons or Corticosteroids within the last 6 months
- •Diabetes or rheumatic diseases
- •Severe medical illness: ASA score higher than or equal to
- •(ASA: American Society of Anesthesiologists physical status classification system)
结局指标
主要结局
Achilles tendon total rupture score ATRS
时间窗: 13 weeks
Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.
次要结局
- The fear of re-rupture(9, 13 and 52 weeks)
- Compliance(9 weeks)
- Achilles tendon resting angle (ATRA)(13 and 52 weeks)
- Adverse events(9, 13 and 52 weeks)
- International Physical Activity Questionnaire (IPAQ)(baseline, 13, 26 and 52 weeks)
- Achilles tendon length(9, 13 and 52 weeks)
- Isometric muscle strength(9, 13 and 52 weeks)
- Muscle endurance(13 and 52 weeks)
- Achilles tendon total rupture score ATRS(Baseline, 26 and 52 weeks)
研究者
Marianne Christensen
PT, PHD student
Aalborg University Hospital