Laval University Rouge et Or Post Anterior Cruciate Ligament Surgery Readaptation Program Effectiveness With Amateur Athletes: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Knee Outcome Survey-Activity of Daily Living Scale
研究概览
简要总结
The main objective is to compare the effectiveness of two readaptation programs post anterior cruciate ligament surgery. Laval University Rouge et or program is to be compared with the intervention guide from the CHU. Amateur athletes are recruited 3 months post ACL surgery. The level of confidence, symptoms, functional recovery level and muscle strength are assessed and compared between the two groups at 3, 4, 5, 6 and 9-month post surgery.
详细描述
It is experimental research with pre-post repeated measure with a control group. The subjects are randomised either in the intervention group (Gr PRORO-UL) or the control group (Gr CHU-CP). The assessor is blinded to the randomisation. Both groups receive their program at the first assessment at three months post-ACL-surgery. They are strongly encouraged to continue their follow-up in physiotherapy to ensure the program is suitable to their individual progression. The participants are assessed again at 4, 5, 6 and 9 months post surgery to measure their progression. A weekly journal sent by e-mail is to be filled to ensure the subjects train according to their program attribution. It is a randomised control trial with a blinded assessor.
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)
盲法说明
Subjects are randomised to one of the two groups: Rouge et or program or Chu protocol. The assessor that perform the multiple assessments is blinded to the randomisation.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Amateur athlete aged from 18 to 35 years old doing sports at least 3 times a week
- •Having suffered from an Anterior Cruciate Ligament rupture
- •Having undergone Anterior Cruciate Ligament surgery either with an anterior approach (with the patellar tendon) or a posterior approach (with the semitendinosus tendon)
- •Having a functional deficit (score 85% or under at Knee Outcome Survey - Activity of Daily Living Scale questionnaire and/or score 80% or under at International Knee Documentation Committee questionnaire)
- •Being available for follow up and actively follow the programme attributed.
排除标准
- •Having suffered from multiple surgery for other ligaments in the same knee.
- •Having undergone total meniscus removal
- •Having suffered form Posterior Cruciate Ligament rupture.
- •Having other injuries that could affect the functional performance and prevent from training.
研究组 & 干预措施
Rouge et Or program
Rouge et Or program group follow a detailed program that they do on their own. It is made of three cycles of four weeks each. Every cycle contains 3 training sessions by week with a minimum of 24 hours between sessions. The training volume is modulated for every cycle and every week. Each training sessions is made of 6 warm-up exercises followed by 6 training exercises. The exercises are a mix of strengthening, endurance, plyometric, neuromuscular control and dynamic stability. The exercises change every month with a progressively increasing difficulty towards the end to mimic return to sport demands.
干预措施: Rouge et Or Program (Other)
CHU intervention guide
CHU intervention guide group follow the standard CHU protocol. At three months post-surgery, the protocol suggests progressing the exercises without precisely suggesting exercise, parameter or frequency.
干预措施: CHU intervention guide (Other)
结局指标
主要结局
Change in Knee Outcome Survey-Activity of Daily Living Scale
时间窗: 3, 4, 5, 6 and 9 months post-surgery
Questionnaire ranging from 0 to 70 over 70 where 70 means no limitation in activity of daily living. There is 14 questions with each graded answer providing 0 to 5 points that are summed together and expressed in percentage. The higher is the score, the better is the outcome.
次要结局
- Single leg hop test.(9 months post-surgery)
- 30 seconds side hop test(9 months post-surgery)
- Change in Anterior Cruciate Ligament Return to Sport Index(3, 4, 5, 6 and 9 months post-surgery)
- Muscle strength(9 months post-surgery.)
- Change in International knee documentation committee(3, 4, 5, 6 and 9 months post-surgery)
- Numerical Pain Rating Scale(9 months post-surgery)
- Triple hop test.(9 months post-surgery)
- Global Rating Of Change(9 post-surgery)