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NCT Number: NCT05527171

Virtual Reality Mindfulness Meditation After ACL Reconstruction

To evaluate the effect of virtual reality mindfulness meditation on patients after ACLR, the investigators will determine the effect of virtual reality mindfulness meditation to 1) decrease self-reported injury-related fear, 2) improve poor jump-landing movement patterns, and 3) improve brain activity in women 1 to 5 years post-ACLR when compared to a virtual reality sham group.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

14 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fetzer Hall, 210 South Road

Chapel Hill, North Carolina, 27514, United States

Location status: Recruiting

Location contact

Shelby E Baez, PhD

CONTACT

[email protected]

About this study

Injury-related fear after anterior cruciate ligament (ACL) injury significantly contributes to decreased return to sport, decreased physical activity engagement, and increased ACL reinjury risk in previously high functioning, physically active individuals. Injury-related fear is also associated with poor jump-landing movement patterns in patients after ACL reconstruction (ACLR). Unfortunately, current rehabilitation practices do not specifically address injury-related fear in patients after ACLR. Virtual reality mindfulness meditation is a mental practice that involves focusing the mind on experiences in the present moment and has been used to address depression, anxiety, and chronic musculoskeletal pain. To evaluate the effect of virtual reality mindfulness meditation on patients after ACLR, the investigators will determine the effect of virtual reality mindfulness meditation to 1) decrease self-reported injury-related fear, 2) improve poor jump-landing movement patterns, and 3) improve brain activity in women 6 months to 10 years post-ACLR when compared to a virtual reality sham group. Patients in the intervention group will complete 8-weeks of virtual reality mindfulness meditation + an advanced rehabilitation training program. Patients in the sham group will complete 8-weeks of the virtual reality sham + an advanced rehabilitation training program. The central hypothesis is that women 6 months to 10 years post ACLR who undergo virtual reality mindfulness meditation will demonstrate decreased injury-related fear, improved jump-landing movement patterns, and improved brain activity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Ages 14-25 years
  • Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11
  • Have poor jump-landing movement quality as measured by the Landing Error Scoring System-Real Time
  • Injured their knee playing or training for sports (recreational or organized)
  • Right-hand dominant
  • 6 months to 10-years post-ACLR
  • Demonstrate magnetic resonance imaging (MRI) compliance

Exclusion criteria

  • Male
  • Concussion in the past 3 months
  • Presence of metal fragments, pins, plates, or clips, shrapnel, permanent makeup, body piercings that cannot be removed, surgical implants, or orthodontics that cannot be removed
  • On any medication that affects the central nervous system
  • Any neurological conditions (i.e. epilepsy)
  • Claustrophobia
  • Under the influence of alcohol or other recreational drugs
  • Pregnancy or suspicion of pregnancy

Treatment and study plan

Virtual Reality Mindfulness Meditation

Behavioral

Participants will be immersed in a virtual environment of their choosing. While in the virtual environment, participants will follow a guided mindfulness meditation script. Participants will complete the intervention 3 times a week over the course of 8-weeks.

Virtual Reality Sham

Behavioral

Participants will be immersed in a virtual environment of their choosing, such as at a beach, forest, or lake.

Primary outcomes

  1. Percentage of participants who were eligible and enrolled in the study

    Time frame: Through study completion, a total of approximately 3 years.

    Feasibility of the Virtual Reality and Advanced Neuromuscular Training Rehabilitation Program will be assessed through established recruitment for patients post-ACLR. Recruitment is defined as the percentage of participants who were eligible and enrolled in the study.

  2. Percentage of participants retained in the study

    Time frame: Through study completion, a total of approximately 8-weeks

    Feasibility of Virtual Reality and Advanced Neuromuscular Training Rehabilitation Program will be assessed to determine participant retention. Retention is defined as the percentage of participants enrolled and who have completed all study measures through 8-weeks.

  3. Mean Acceptability Survey Score

    Time frame: Collected post-treatment after completion of the intervention/sham at week 8

    Feasibility of Virtual Reality and Advanced Neuromuscular Training Rehabilitation Program will be assessed via an acceptability survey during the final assessment post-treatment at week 8. Mean score greater than 8 will be interpreted as high acceptability.

  4. Change in Injury-related fear as measured by the Tampa Scale of Kinesiophobia-11

    Time frame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8

    The Tampa Scale of Kinesiophobia-11 is a patient-reported outcome measure that assesses fear of movement and/or reinjury. This is an 11-item questionnaire that is valid. Scores range from 11 to 44, with higher scores indicating elevated fear.

Secondary outcomes

  1. Change in external knee abduction moment

    Time frame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8

    External knee abduction moment is a biomechanical assessment pertinent to patients with ACL reconstruction. Increased knee abduction moment has been associated with ACL reinjury risk. Patients will complete a jump-landing task to assess knee abduction moment using a three-dimensional motion capture system and embedded force plates.

  2. Change in knee flexion excursion

    Time frame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8

    Knee flexion excursion is a biomechanical assessment pertinent to patients with ACL reconstruction. Decreased knee flexion excursion has been associated with ACL reinjury risk. Patients will complete a jump-landing task to assess knee flexion excursion using a three-dimensional motion capture system and embedded force plates.

  3. Change in Mean percent Blood Oxygen Level Dependent signal in Default Mode Network.

    Time frame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8

    Blood Oxygen Level Dependent (BOLD) fMRI is a non-invasive diagnostic method of assessing brain activity by detecting signal changes secondary to changes in blood flow and oxygenation. Increased mean percent BOLD signal is associated with increased brain activity and decreased mean percent BOLD is associated with decreased brain activity.

    BOLD signal will be measured during a picture imagination task with sport-specific images and activity of daily living (ADL) images presented during the fMRI scan. Images are presented for 3 seconds with a 12-second rest between images. Whole brain functional images will be collected via a 3T PRI Scanner. Functional data will be acquired with BOLD echoplanar imaging (EPI) and processed using Analysis of Functional NeuroImages (AFNI). Mean BOLD percentage change based on image category, sport-specific versus ADL, will be examined.

Study contacts

Contact information is provided by the study sponsor or research team.

Shelby E Baez, Ph.D., ATC

CONTACT

[email protected]

910-273-1821

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Virtual Reality Mindfulness Meditation in Patients After Anterior Cruciate Ligament Reconstruction

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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