Anterior Cruciate Ligament Injuries Clinical Trial
Official title:
The Use of Visuomotor Therapy to Modulate Corticospinal Excitability in Patients Following ACL-Reconstruction
NCT number | NCT04495075 |
Other study ID # | 20441 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | March 1, 2020 |
Verified date | July 2020 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - • 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) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quadriceps Motor Evoked Potential (micoVolts) PreSham (Passive Motion) | Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis | 6-months post-Anterior Cruciate Ligament Reconstruction | |
Primary | Quadriceps Motor Evoked Potential (micoVolts) PostSham (Passive Motion) | Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis | 6-months post-Anterior Cruciate Ligament Reconstruction | |
Primary | Change in Quadriceps Motor Evoked Potential - Sham (Passive Motion) | Difference in microVolts between pre-sham measure and post-sham measure | 6-months post-Anterior Cruciate Ligament Reconstruction | |
Primary | Quadriceps Motor Evoked Potential (micoVolts) PreActive (Visuomotor Therapy) | Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis | 6-months post-Anterior Cruciate Ligament Reconstruction | |
Primary | Quadriceps Motor Evoked Potential (micoVolts) PostActive (Visuomotor Therapy) | Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis | 6-months post-Anterior Cruciate Ligament Reconstruction | |
Primary | Change in Quadriceps Motor Evoked Potential - Active (Visuomotor Therapy) | Difference in microVolts between pre-active measure and post-active measure | 6-months post-Anterior Cruciate Ligament Reconstruction |
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