The Effects of a Lower Limb Strengthening Training Program During Prehabilitation Prior to ACL Surgery on Lower Limb Structure and Function : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in patient's opinion to return to sport
研究概览
简要总结
Atrophy and weakness are ubiquitous after a ACL rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. Preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. However, prehab programs are highly variable, and do not always aim to develop/maintain neuromuscular parameters.
The purpose of this study is to assess the effects of a lower limb strengthening training program during prehab prior to ACL Surgery on lower limb structure and function.
详细描述
Recruited participants will be randomly allocated to one of the three groups of participants constituted in this study.
The two first groups will receive prehabilitation prior to ACL reconstruction (differing in program type). All participants will receive standardized post-surgery rehabilitation (based on international recommandations).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age : 18 to 55
- •first episode of ACL injury
- •having a planed ACL reconstruction
- •volunteer to participate
排除标准
- •age : <18 or >55
- •previous episode of ACL injury/reconstruction
- •no ACL reconstruction
结局指标
主要结局
Change in patient's opinion to return to sport
时间窗: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Patient's self-related opinion out the impact of returning to sport will be assessed using the Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) questionnaire. The ACL-RSI consists of 12 questions. Unit : score, scaled between 0 (=bad) and 100 (= more psychologically ready to return to sport)
Change in the stiffness of knee muscles
时间窗: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
An index of muscle stiffness will be assessed via the shear modulus using ultrasound shear wave elastography, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : kiloPascals (kPa)
Change in lower limb function
时间窗: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Single leg hop test. Participants will be instructed to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. Unit : centimeters (cm)
Changes in muscle strength of the knee muscles
时间窗: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Maximal muscle strength of knee flexors/extensors will be assessed using isokinetic dynamometer, and extension and flexion torques during a maximum voluntary contraction (MVC). Unit : Newton meter (Nm)
Change in muscle volume of the knee muscles
时间窗: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Muscle volume of the knee muscles (hamstring and quadriceps) will be assessed using 3D ultrasound imaging, at rest in a prone (hamstring) or supined (quadriceps) position. Unit : millimeters (mL)
Change in patient's opinion about the knee and associated problems
时间窗: week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term)
Patient's self-related opinion about symptoms and activity will be assessed using the International Knee Documentation Committee Subjective Knee Form (IKDC).The IKDC is consisted of 10 questions. Unit : score, scaled between 0 (=bad) and 100 (= good function)
次要结局
- Health consumption(week 0 (baseline); week 9 (post-intervention, short term) ; 6 months after the surgery (post-intervention, mid-term) and 12 months after the surgery (post-intervention, long-term))
研究者
Guillaume Le Sant
Guillaume Le Sant, PhD,PT. Physiotherapist and Researcher
Université de Nantes