Early Treatment Based Neuroscience Education in Anterior Cruciate Ligament Repair Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Changes in quadriceps strength.
研究概览
简要总结
Determine the effecttiveness of a cross-education strength training protocol in a group of subjects with an anterior cruciate ligament surgery.
详细描述
The cross-education (CE) phenomenon has been studied in recent years as a form of gain muscle strength not only in healthy subjects but also in acute injuries such as musculoskeletal disorders and immovilitations. Unilateral training of the not injured limb has been suggested as an option to produce cross-edutation in terms of strength and skills. In addition, functional magnetic resonance imaging have been postulated as a promising tool to study the mechanisms of transfer.
In the context of our study, arthrogenic muscle inhibition (AMI) of knee extensors is a common consequence after ACL repair in which a CE strength training can lead to reduce quadriceps atrophy and its implications in long terms achievements. Thus, an unilateral strength protocol of the uninjuried limb, according to the last Delphi Consensus, will be run for 10 weeks to check the possible benefits of the transfer in a sample of ACL repair.
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
Assessors are not aware of the allocation group of the participants
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People between 18 and 40 years whith MRI diagnosis of ACL rupture.
- •Autograft, allograft or artificail graft of any source.
- •With/without any meniscal resection/repair.
排除标准
- •Diagnosis of systematic disease, no injury or symptomatic in contralateral lower limb, pregnancy, current or prior neurologic condiction.
研究组 & 干预措施
Control group
Standard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016.
干预措施: Best current rehabilitation protocol (Other)
Cross-education group
Standard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016.
Additionally a contralateral lower limb strength training.
干预措施: Best current rehabilitation protocol (Other)
Cross-education group
Standard protocol rehabilitation programme for an anterior cruciate ligament repair based on VAN MELICK N, et al 2016.
Additionally a contralateral lower limb strength training.
干预措施: Cross-training protocol (Other)
结局指标
主要结局
Changes in quadriceps strength.
时间窗: Baseline and 12 weeks post-surgery
Isometric Maximal voluntary contraction in 60º/90º of knee flexion. Both legs. Patients performed two familiarization trials at 50% of their estimated MVC. Then 3 test of maximal contraction will be done. Measured in newtons.
Changes in cortical adaptation.
时间窗: Baseline and 10 weeks post-surgery
Functional magnetic resonance including tractography, blood oxygen level dependent (BOLD) and resting-state study to measure how and where the cortical activation is meanwhile the subjects perform a 50% of the MVIC of knee extension with the injuried leg. Special focus on primery motor cortex and supplementary motor area.
Changes in quadriceps strength.
时间窗: Pre-surgery and 12 week post-surgery
Isometric Maximal voluntary contraction in 60º/90º of knee extension. Both legs. Patients performed two familiarization trials at 50% of their estimated MVC. Then 3 test of maximal contraction will be done. Measured in newtons.
Structural changes in brain.
时间窗: Pre-surgery and 12 week post-surgery
Fractional anisotropy (FA) and mean diffusivity (MD) will be used for measure white matter microstructure and corticospinal tracts with diffusion tensor imaging (DTI). Voxel-based morphometry (VBM) will be used to measure volumen, thickness and size of white matter in with T1-weighted images.
Functional changes in brain
时间窗: Pre-surgery and 12 week post-surgery
Functional magnetic resonance imaging (fMRI) with active and resting blocks of knee extensions in both legs, and resting-state imaging. Blood-oxygen level dependent (BOLD) will be used for measure functional connectivity in resting and during motor task.
次要结局
- Limb symmetry index (LSI).(Pre- surgery, 12 weeks post-surgery)
- Contact time with the ground during gait(12 weeks post-surgery)
- Cadence of the gait(12 weeks post-surgery)
- Muscle activation.(Pre- surgery, 12 weeks post-surgery)
- Muscle thickness of quadriceps.(Pre- surgery, 12 weeks post-surgery)
- Peak rate of force development (RFD).(Pre- surgery, 12 weeks post-surgery)
- Cross-sectional area of quadriceps(Pre- surgery, 12 weeks post-surgery)
- The Lysholm questionnaire.(12 weeks post-surgery)
- The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.(12 weeks post-surgery)
- The International Knee Documentation Committee (IKDC) questionnarie.(12 weeks post-surgery)
- Step length during gait(12 weeks post-surgery)
- Limb symmetry index (LSI).(Pre- surgery, 12 week post-surgery)
- Peak rate of force development (RFD).(Pre- surgery, 12 week post-surgery)
- Muscle activation(Pre- surgery, 6 week post-surgery, 12 week post-surgery)
- Cross-sectional area of quadriceps(Pre- surgery, 12 week post-surgery)
- The International Knee Documentation Committee (IKDC) questionnarie.(Pre- surgery12 weeks post-surgery)
- The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire.(Pre-surgery, 2 week, 4 week, 6 week, 8 week, 10 week and 12 week post-surgery)
- Muscle thickness of quadriceps.(Pre- surgery, 12 week post-surgery)
- Single leg stand(Pre-surgery, 6 week and 12 week post-surgery)
- Double leg squat assessment(Pre-surgery, 6 week and 12 week post-surgery)
- The TSK-11 questionnaire(Pre- surgery, 12 week post-surgery)
研究者
Dr. Antonio I Cuesta-Vargas
Director, Clinical Research
University of Malaga