The EFficacy of COntralateral Muscle Rehabilitation Exercise Following Anterior Cruciate Ligament Reconstruction (EFCOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Muscle Strength (peak force)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a cross-education rehabilitation intervention following anterior cruciate ligament reconstruction on ameliorating the acute losses to function and performance. The cross-education phenomenon describes the strength gain in the opposite, untrained (surgical) limb following unilateral resistance training of the 'trained' (non-surgical) limb.
详细描述
Protocol:
44 eligible and consenting patients (allowing for 20% attrition) with unilateral anterior cruciate ligament (ACL) injury that have elected to undergo surgical reconstruction will be recruited into this study. Patients will be randomly assigned to one of two different conditions: 1) standard ACL rehabilitation plus 8-weeks of contralateral muscle resistance training, [INTERVENTION]; 2) standard ACL rehabilitation plus placebo exercises (time-matched unrelated upper limb flexibility exercises, [CONTROL].
Assessments of knee extensor and knee flexor neuromuscular performance of both limbs will be obtained prior to, at 10-weeks post- and at 6-months post- surgery. Assessments of function (1-leg hop for distance) and patient-reported outcomes (International Knee Documentation Committee [IKDC]) will also be conducted at these times. Further, all patients will be asked to wear a tri-axial accelerometer to gain an objective measure of habitual physical activity (PA) and sedentary time and pattern for one week pre-surgery (5 weekdays and 2 weekend days), during the first and final week of the INTERVENTION/CONTROL and then again at 6 months post- INTERVENTION/CONTROL.
The initial assessments at 10-weeks post-surgery will evaluate the efficacy of the contralateral training programme, specifically whether the training intervention on the non-injured leg elicited changes in the performance of the injured leg compared to the control group. The assessments at 6-months post-surgery will evaluate any carry-over effects of the contralateral training programme, specifically whether any changes in performance of the injured leg were retained at 6-months post-surgery compared to the control group. 6-months post-surgery is currently the earliest opportunity when we would permit patients to return to sports and activities.
ACL surgeries will be performed by the same three surgeons at the RJAH Orthopaedic Hospital throughout the study and according to standardised techniques and procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mentally mature
- •Listed for unilateral ACL reconstructive surgery following informed surgical consent
- •Autologous graft tissue; either patella tendon or semitendinosus and gracilis from the ipsilateral leg
排除标准
- •Patients under 16 or over 50 years of age
- •Patients with systemic pathologies (e.g. renal failure)
- •Symptomatic non-operative knee
- •Additional ligament injuries, meniscal transplant and,or, articular cartilage repair to the operative knee
结局指标
主要结局
Muscle Strength (peak force)
时间窗: 10-weeks post ACL-reconstruction
次要结局
- Patient perceived knee function(10-weeks and 6-months post ACL-reconstruction)
- Muscle Strength (peak force)(6-months post ACL-reconstruction)
- Physical activity (PA)(10-weeks and 6-months post ACL-reconstruction)
- Functional capability(6-months post ACL-reconstruction)
- Limb symmetry index(10-weeks and 6-months post ACL-reconstruction)