Functional Connectivity After Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction
研究概览
简要总结
Background:
Despite surgical reconstruction and rehabilitation, individuals after a primary anterior cruciate ligament injury have a significantly increased risk of relapse. The mechanisms for this increased risk may go beyond mere physiological and biomechanical changes of the reconstructed anterior cruciate ligament. The loss of ligamentous mechanoreceptors can affect sensory feedback and consequently result in a disrupted afferent input to the central nervous system. However, research on the neuroplasticity of the central nervous system after anterior cruciate ligament injury and more specifically on the cooperation between different brain areas (=functional connectivity) in motor execution and performance is limited.
Research purpose:
To investigate the changes in terms of functional connectivity in the brain after sustaining an anterior cruciate ligament injury and associated reconstruction?
Population:
- Patients after anterior cruciate ligament reconstruction
- Healthy controls
Protocol:
First, all participants are required to complete several questionnaires regarding the level of anxiety and the functioning of the knee in daily activities and sports. In addition, during the baseline testing, participants will be required to perform an experiment while electrical brain activity is recorded by means of an electroencephalography (EEG) measurement. During this experiment, the participants will have to successively perform the following exercises: 10x knee extension from sitting (left and right), 10x bipodal squat from standing, 5x 30 seconds unipodal standing (left and right).
The above protocol will be administered to the patient group for the first time 8 weeks after the anterior cruciate ligament reconstruction. When the patients do not need further rehabilitation, they will be invited a second time to execute the same protocol again. The control group will only have to carry out the above protocol once.
Finally, for one year after the last test, the patient group will be contacted monthly to monitor return to sport and the occurrence of injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 18 years of age.
- •Primary anterior cruciate ligament rupture and reconstruction
排除标准
- •Major knee surgery in the past.
- •Diagnosed with any knee pathology at this moment.
- •Have any muscle or nerve related conditions that affect the functioning of the lower limbs.
- •CONTROL GROUP
- •Inclusion Criteria:
- •Older than 18 years of age.
- •Exclusion Criteria:
- •Major knee surgery in the past.
- •Diagnosed with any knee pathology at this moment.
- •Have any muscle or nerve related conditions that affect the functioning of the lower limbs.
结局指标
主要结局
Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction
时间窗: Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline
Electroencephalography (EEG) will be recorded from a 128 Sn surface electrode cap during 3 motor tasks. Functional connectivity will be analyzed.
次要结局
- Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire(Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline)
- Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - Questionnaire(Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline)
- Change in knee confidence - Questionnaire(Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline)
- Change in athletes' emotion, confidence, and risk appraisal when returning to sports after an anterior cruciate ligament reconstruction measured by the ACL-Return to sport after injury (ACL-RSI) - Questionnaire(Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline)
- Follow up questionnaire(Monthly, for one year after the end of the rehabilitation (on average 9-12 months postoperative).)
- Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - Questionnaire(Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline)