NCT05527171 · University of North Carolina, Chapel Hill
Virtual Reality Mindfulness Meditation After ACL Reconstruction
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Virtual Reality Mindfulness Meditation
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.
BEHAVIORAL
Virtual Reality Sham
Participants will be immersed in a virtual environment of their choosing, such as at a beach, forest, or lake.
Primary outcome measures
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Chapel Hill, North Carolina
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations