Effects of Transcranial Direct Current Stimulation Over Motor Cortex During Recovery of ACL Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Electromyography (EMGs)
研究概览
简要总结
Anterior Cruciate Ligament (ACL) is a prevalent injury, particularly among young and physically active individuals. The efficacy of transcranial direct current stimulation (tDCS) and exercise-based rehabilitation on neuromuscular control in post-ACL reconstruction patients is evaluated, and these techniques are combined.
详细描述
Anterior cruciate ligament (ACL) rupture is a common injury, particularly among young and physically active individuals, with an incidence of 0.4 to 0.8 injuries per 1,000 person-years. While the majority of ruptures occur during sports activities (65-75%), a significant proportion (25-35%) happen in non-sport settings. Rehabilitation is crucial for recovery, but only 65% of patients return to their pre-injury activity level, and only 55% resume competitive activities. Neuromuscular structures such as the hamstrings and hip abductors play a vital role in reducing the risk of re-injury and aiding post-surgical rehabilitation.
Arthrogenic muscle inhibition (AMI) is a common phenomenon following ACL surgery, affecting quadriceps activation and force generation. While spinal mechanisms of AMI have been extensively studied, the influence of supraspinal centers, such as the motor cortex, in modulating AMI is also recognized. Traditional treatments, such as electrostimulation, are largely ineffective, and non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), combined with exercise rehabilitation, are being explored to improve neuromuscular control.
This study aims to evaluate the effects of combined tDCS and exercise-based rehabilitation, comparing it to sham tDCS treatment. Outcomes will include cortical reorganization, corticospinal activation, pain perception, and psychosocial and functional variables. The central hypothesis is that reducing cortical hyperexcitability will enhance neuromuscular control, leading to improved outcomes and a reduced risk of re-injury.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The groups will be randomly assigned, and a double-blind procedure will be employed as the masking technique. Subject selection will be conducted randomly using the EPIDAT 3.1 program. Both the participants and the researcher responsible for data collection will remain unaware of the assigned intervention and the results obtained, respectively, until the study's conclusion. An independent researcher will generate a table of random numbers using an Excel formula to blind data collectors and outcome adjudicators, thereby ensuring unbiased outcome ascertainment.
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis complete ACL tear through clinical evaluation and MRI imaging.
- •Patients who have received surgical intervention.
- •Aged between 16 and 40 years.
- •Tegner activity level of 4 or higher.
排除标准
- •Rupture, such as tendons, cartilage, bones, or ligaments.
- •Absence of any pre-existing or current lower limb pathologies, such as open surgeries, knee arthroscopies, or femur/tibia fractures.
- •Neuromuscular or metabolic diseases.
- •Concussion within the past six months are not eligible.
- •Cranial surgery or have intracranial metal clips are ineligible.
- •Taking medications that affect neuronal activity.
- •Neurological diseases or disorders are not eligible for participation.
研究组 & 干预措施
NIBS + rehabilitation
The intervention using tDCS will be performed through the Home tDCS device (Ionclinics®). It will be introduced in the first part of the rehabilitation, during activation, because the required exercises will be of lower intensity, complexity, and more compatible with this intervention.
干预措施: NIBS (Device)
NIBS + rehabilitation
The intervention using tDCS will be performed through the Home tDCS device (Ionclinics®). It will be introduced in the first part of the rehabilitation, during activation, because the required exercises will be of lower intensity, complexity, and more compatible with this intervention.
干预措施: Rehabilitation (Procedure)
ShamNIBS + RHB
The device will be configured to produce an ascending ramp lasting 30 seconds, identical to the one used in the experimental group, followed by a descending ramp of another 30 seconds. Thus, the control group will experience a sensation of tingling on the scalp, similar to that felt by the experimental group. This stimulation will have a total duration of 1 minute, which will not be sufficient to induce changes in cortical excitability
干预措施: Rehabilitation (Procedure)
ShamNIBS + RHB
The device will be configured to produce an ascending ramp lasting 30 seconds, identical to the one used in the experimental group, followed by a descending ramp of another 30 seconds. Thus, the control group will experience a sensation of tingling on the scalp, similar to that felt by the experimental group. This stimulation will have a total duration of 1 minute, which will not be sufficient to induce changes in cortical excitability
干预措施: Sham Comparator (Behavioral)
结局指标
主要结局
Electromyography (EMGs)
时间窗: At baseline, 90days post-surgery, 180days post-surgery
The The Surface EMG amplitudes of the quadriceps and hamstring muscles. The main device, Musclelab, is equipped with a Musclelab force sensor and wireless surface elec-tromyography (EMGs). Electrode placement will follow the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscle (SENIAM) protocol from the European Concerted Action in the Biomedical Health and Research Program (BIOMED II). The instructions provided to the patients will be to perform the movement with the max-imum possible contraction, and as rapidly as possible, to achieve the highest peak of force. The patient will carry out 3 familiarization repetitions at a submaximal inten-sity at the beginning of each repetition, and it will begin with the non-surgical ex-tremity, followed by the tests on the surgical extremity. Three effective MVIC attempts will be conducted, each lasting 5 seconds, with a 30-second rest interval between each repetition .
次要结局
- Anterior Cruciate Ligament - Quality of Life Questionnaire (ACL - QOL)(At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery)
- Lysholm Scale(At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery)
- Functional Jump Test(60days post-surgery, 90days post-surgery and 180days post-surgery)
- Tampa Scale of Kinesiophobia(At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery)
- Pain Catastrophizing Scale(At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery)
- EGGTMS(At baseline, 90days post-surgery, 180days post-surgery)