Neuromuscular Control in Individuals Following ACL-Reconstruction

NCT04495075 | Completed

• 1 other identifier: 20441
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries; Quadriceps Muscle Atrophy

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

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.

Other: Passive Motion

Interventions

Visuomotor Therapy OTHER

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.

Also known as: Motor Biofeedback

Visuomotor Therapy

Passive Motion OTHER

The knee is passively moved through a range of motion.

Passive Motion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joe M Hart, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessing investigator was blinded to the intervention that was received by the participant.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Laboratory Controlled Crossover Study

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 31, 2020
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)