The Use of Visuomotor Therapy to Modulate Corticospinal Excitability in Patients Following ACL-Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Quadriceps Motor Evoked Potential (micoVolts) PreSham (Passive Motion)
研究概览
简要总结
The purpose of this study is to investigate the neurophysiological contributors to muscle function following ACL Reconstruction and the influence of motor control biofeedback exercise on measures of muscle function. The research team hypothesizes that the application of motor biofeedback will increase cortical excitability of the quadriceps compared to the passive movement of the knee.
This is a single session cross-over intervention study with a 1-week washout period between treatment arms.
详细描述
- Pre-treatment neuromuscular assessment Cortical Active Motor Threshed We will measure motor evoked potentials with the use of a Transcranial magnetic stimulator (MagStim model 200, Magstim Co., Ltd., Wales, UK). The MagStim has FDA 510K Clearance for stimulation of peripheral nerves.
- The participant will be asked to sit in the dynamometer (Biodex, System 3) in knee extension at 90 degrees of knee flexion.
- EMG electrodes will be placed on the distal quadriceps
o Local shaving, debridement, and cleaning will be done prior if necessary
-
A non-latex swim cap will be placed on the participants head for investigator's measurements
-
Briefly, a magnetic field with a maximum value of 2.2 Tesla will be introduced to the scalp at a location in the pre-motor cortex that corresponds to the quadriceps. Single pulse stimulations will be delivered with no less than 10 seconds between stimulations (maximum = 0.1 Hz).
-
When the magnetic field is received at the premotor cortex at the appropriate area, a motor signal is sent to the quadriceps. We will record this signal with surface EMG electrodes that are on the quadriceps.
-
The participant will be asked to extend their leg to match a force equivalent to 5% MVIC. Feedback will be provided to the participant to provide such force.
-
Stimulation of the TMS will happen once every ten seconds until the Active Motor Threshold was found by the investigator.
-
The motor evoked potential measured by the quadriceps will be recorded at 80%, 90%, 100%, 110%, 120%, 130%, 140%, and 150% of the patients Active motor threshold.
- Patient randomization
- The patient is then randomized to 1 of 2 treatment arms. 1) Visuomotor Therapy or 2) Passive Motion
- Perform Randomized Treatment Visuomotor Therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessing investigator was blinded to the intervention that was received by the participant.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Ages 18-45
- •At the time point of return to play progression following ACL Reconstruction
- •Physically active individuals based on current ACSM guidelines of 30 minutes of moderate-intensity daily physical activity three days a week)
排除标准
- •Subjects who are known to be pregnant (self-reported)
- •Subjects diagnosed with malignancy
- •Subjects with serious infection near the lower limb
- •Subjects with known muscular abnormalities
- •History of cardiopulmonary disorder
- •Subjects with a previous history of stroke
- •History of neurological or psychiatric disorders including poorly controlled migraine headaches, seizure disorder, history or immediate family history of seizures and/or epilepsy
- •Subjects with any type of neuropathy (numbness and tingling)
- •Subjects with a clinical diagnosis of multiple sclerosis (MS) or Parkinson's Disease
- •Implanted biomedical device (active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, and vagus nerve stimulators)
- •History of skull fracture
- •Subjects who have any metal implants anywhere in their head, neck or shoulders
- •Patients taking any medications, which may influence cortical excitability, which could influence neurophysiologic measures) and affect objective clinical data (e.g. antispastics, anxiolytics, hypnotics, ant-epileptics)
- •Subjects who are prescribed medications which may influence cortical excitability, which could influence neurophysiologic measures) and affect objective clinical data (e.g. antispastics, anxiolytics, hypnotics, ant-epileptics), will not be able to remain in the study.
- •Unable to provide consent.
结局指标
主要结局
Quadriceps Motor Evoked Potential (micoVolts) PreSham (Passive Motion)
时间窗: 6-months post-Anterior Cruciate Ligament Reconstruction
Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis
Quadriceps Motor Evoked Potential (micoVolts) PostSham (Passive Motion)
时间窗: 6-months post-Anterior Cruciate Ligament Reconstruction
Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis
Change in Quadriceps Motor Evoked Potential - Sham (Passive Motion)
时间窗: 6-months post-Anterior Cruciate Ligament Reconstruction
Difference in microVolts between pre-sham measure and post-sham measure
Quadriceps Motor Evoked Potential (micoVolts) PostActive (Visuomotor Therapy)
时间窗: 6-months post-Anterior Cruciate Ligament Reconstruction
Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis
Change in Quadriceps Motor Evoked Potential - Active (Visuomotor Therapy)
时间窗: 6-months post-Anterior Cruciate Ligament Reconstruction
Difference in microVolts between pre-active measure and post-active measure
Quadriceps Motor Evoked Potential (micoVolts) PreActive (Visuomotor Therapy)
时间窗: 6-months post-Anterior Cruciate Ligament Reconstruction
Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis
次要结局
未报告次要终点
研究者
Joseph Hart
Associate Professor
University of Virginia