Anterior Cruciate Ligament InjuriesNCT04495075
Neuromuscular Control in Individuals Following ACL-Reconstruction
A study testing Visuomotor Therapy and Passive Motion in people with Anterior Cruciate Ligament Injuries and Quadriceps Muscle Atrophy, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Quadriceps Muscle Atrophy
- What is being tested?
- Visuomotor Therapy and Passive Motion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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)
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: The Use of Visuomotor Therapy to Modulate Corticospinal Excitability in Patients Following ACL-Reconstruction
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.
Read the detailed description
- 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
- 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
- The participant will sit in the Biodex chair with the tested limb secured in the dynamometer
- The participant will receive live real-time biofeedback of their knee force output (no more than 30% of maximum force)
- The participant will aim to match their force output to a target threshold presented on the screen.
- The participant will complete 10 60-second trials of this exercise with a 30 second rest between each trial. OR Passive Motion
- The participant will sit in the Biodex chair with the tested limb secured in the dynamometer
- The dynamometer will passively move the patients lower limb between 80 to 120 degrees of knee flexion
- The participant will be asked to relax for the duration of testing - The participant will complete 10 60-second trials of this exercise with a 30 second rest between each trial.
- Reassess Neuromuscular outcome (Step 1)
- 1-week washout period
- Repeat Steps 1 through 4 but the patient receives the cross-over arm intervention
- Being tested
- Visuomotor Therapy, Passive Motion
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visuomotor TherapyOther
Also called Motor Biofeedback
The use of visual feedback informing internal physiological processes, such as muscle activation, torque, and joint position, has been termed "visuomotor therapy". Visuomotor therapy encompasses completion of sub-maximal motor control tasks accompanying real-time visual biofeedback.
Passive MotionOther
The knee is passively moved through a range of motion.
| Study group | Role | What they receive |
|---|---|---|
| Visuomotor Therapy | Experimental | Patients were seated in the isokinetic dynamometer with their hips flexed to 85º. A target sine wave with a maximum amplitude of 30% MVIC and a minimum amplitude of 5% MVIC and a frequency of 0.128 Hz was visually presented to the patient.31 The patient was instructed to match their torque to the presented target throughout the duration of testing. Each visuomotor therapy trial was 60-seconds, followed by 30-seconds of rest for 10 repetitions, totaling 15 minutes. Receives: Other: Visuomotor Therapy |
| Passive Motion | Active comparator | Patients were seated in the isokinetic dynamometer with their hips flexed to 85º. The dynamometer then passively moved the patient from 80º to 120º of knee flexion for 60-seconds, followed by 30-seconds of rest for 10 repetitions, totaling 15 minutes. The patient was provided visual feedback of their knee position throughout the trials. The patient was instructed to relax their knee throughout the intervention. Receives: Other: Passive Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-months post-Anterior Cruciate Ligament Reconstruction
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
Measured: 6-months post-Anterior Cruciate Ligament Reconstruction
Change in Quadriceps Motor Evoked Potential - Sham (Passive Motion)
Difference in microVolts between pre-sham measure and post-sham measure
Measured: 6-months post-Anterior Cruciate Ligament Reconstruction
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
Measured: 6-months post-Anterior Cruciate Ligament Reconstruction
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
Measured: 6-months post-Anterior Cruciate Ligament Reconstruction
Change in Quadriceps Motor Evoked Potential - Active (Visuomotor Therapy)
Difference in microVolts between pre-active measure and post-active measure
Measured: 6-months post-Anterior Cruciate Ligament Reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Laboratory Controlled Crossover Study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Hart, University of Virginia
- Investigators
- Joe M Hart, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495075
- Sponsor's protocol ID
- 20441
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Visuomotor Therapy to Modulate Corticospinal Excitability in Patients Following ACL-Reconstruction
- ClinicalTrials.gov ID
- NCT04495075
- Acronym / sponsor ID
- 20441
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
- 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
- The participant will sit in the Biodex chair with the tested limb secured in the dynamometer
- The participant will receive live real-time biofeedback of their knee force output (no more than 30% of maximum force)
- The participant will aim to match their force output to a target threshold presented on the screen.
- The participant will complete 10 60-second trials of this exercise with a 30 second rest between each trial. OR Passive Motion
- The participant will sit in the Biodex chair with the tested limb secured in the dynamometer
- The dynamometer will passively move the patients lower limb between 80 to 120 degrees of knee flexion
- The participant will be asked to relax for the duration of testing - The participant will complete 10 60-second trials of this exercise with a 30 second rest between each trial.
- Reassess Neuromuscular outcome (Step 1)
- 1-week washout period
- Repeat Steps 1 through 4 but the patient receives the cross-over arm intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Laboratory Controlled Crossover Study
| Arm | Type | Receives |
|---|---|---|
| Visuomotor Therapy | Experimental | Other: Visuomotor TherapyPatients were seated in the isokinetic dynamometer with their hips flexed to 85º. A target sine wave with a maximum amplitude of 30% MVIC and a minimum amplitude of 5% MVIC and a frequency of 0.128 Hz was visually presented to the patient.31 The patient was instructed to match their torque to the presented target throughout the duration of testing. Each visuomotor therapy trial was 60-seconds, followed by 30-seconds of rest for 10 repetitions, totaling 15 minutes. |
| Passive Motion | Active comparator | Other: Passive MotionPatients were seated in the isokinetic dynamometer with their hips flexed to 85º. The dynamometer then passively moved the patient from 80º to 120º of knee flexion for 60-seconds, followed by 30-seconds of rest for 10 repetitions, totaling 15 minutes. The patient was provided visual feedback of their knee position throughout the trials. The patient was instructed to relax their knee throughout the intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Ages 18-45
Key exclusion criteria (15 listed)
- Subjects who are known to be pregnant (self-reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visuomotor TherapyAlso: Motor BiofeedbackThe use of visual feedback informing internal physiological processes, such as muscle activation, torque, and joint position, has been termed "visuomotor therapy". Visuomotor therapy encompasses completion of sub-maximal motor control tasks accompanying real-time visual biofeedback. | Other | Visuomotor Therapy |
| Passive MotionThe knee is passively moved through a range of motion. | Other | Passive Motion |
Primary outcome
Quadriceps Motor Evoked Potential (micoVolts) PreSham (Passive Motion)
Time frame: 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)
Time frame: 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)
Time frame: 6-months post-Anterior Cruciate Ligament Reconstruction
Difference in microVolts between pre-sham measure and post-sham measure
Quadriceps Motor Evoked Potential (micoVolts) PreActive (Visuomotor Therapy)
Time frame: 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) PostActive (Visuomotor Therapy)
Time frame: 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)
Time frame: 6-months post-Anterior Cruciate Ligament Reconstruction
Difference in microVolts between pre-active measure and post-active measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injuries
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe M Hart, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visuomotor Therapy and Passive Motion in people with Anterior Cruciate Ligament Injuries and Quadriceps Muscle Atrophy, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Motor Evoked Potential (micoVolts) PreSham (Passive Motion) (time frame: 6-months post-Anterior Cruciate Ligament Reconstruction). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.