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Neuromuscular Control in Individuals Following ACL-Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injuries, Quadriceps Muscle Atrophy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visuomotor Therapy
Passive Motion
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Visuomotor Therapy

Passive Motion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
Change in Quadriceps Motor Evoked Potential - Sham (Passive Motion)
Difference in microVolts between pre-sham measure and post-sham measure
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
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
Change in Quadriceps Motor Evoked Potential - Active (Visuomotor Therapy)
Difference in microVolts between pre-active measure and post-active measure

Secondary Outcome Measures

Full Information

First Posted
July 21, 2020
Last Updated
July 28, 2020
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04495075
Brief Title
Neuromuscular Control in Individuals Following ACL-Reconstruction
Official Title
The Use of Visuomotor Therapy to Modulate Corticospinal Excitability in Patients Following ACL-Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Quadriceps Muscle Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Laboratory Controlled Crossover Study
Masking
InvestigatorOutcomes Assessor
Masking Description
Assessing investigator was blinded to the intervention that was received by the participant.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visuomotor Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Passive Motion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Visuomotor Therapy
Other Intervention Name(s)
Motor Biofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Passive Motion
Intervention Description
The knee is passively moved through a range of motion.
Primary Outcome Measure Information:
Title
Quadriceps Motor Evoked Potential (micoVolts) PreSham (Passive Motion)
Description
Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis
Time Frame
6-months post-Anterior Cruciate Ligament Reconstruction
Title
Quadriceps Motor Evoked Potential (micoVolts) PostSham (Passive Motion)
Description
Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis
Time Frame
6-months post-Anterior Cruciate Ligament Reconstruction
Title
Change in Quadriceps Motor Evoked Potential - Sham (Passive Motion)
Description
Difference in microVolts between pre-sham measure and post-sham measure
Time Frame
6-months post-Anterior Cruciate Ligament Reconstruction
Title
Quadriceps Motor Evoked Potential (micoVolts) PreActive (Visuomotor Therapy)
Description
Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis
Time Frame
6-months post-Anterior Cruciate Ligament Reconstruction
Title
Quadriceps Motor Evoked Potential (micoVolts) PostActive (Visuomotor Therapy)
Description
Activation of the Quadriceps muscle through stimulation of primary motor cortex. Measured Through electromyography on the vastus medialis
Time Frame
6-months post-Anterior Cruciate Ligament Reconstruction
Title
Change in Quadriceps Motor Evoked Potential - Active (Visuomotor Therapy)
Description
Difference in microVolts between pre-active measure and post-active measure
Time Frame
6-months post-Anterior Cruciate Ligament Reconstruction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe M Hart, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Neuromuscular Control in Individuals Following ACL-Reconstruction

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