Using virtual reality mindfulness meditation to help women recover after ACL surgery
Virtual Reality Mindfulness Meditation in Patients After Anterior Cruciate Ligament Reconstruction
This study is testing if virtual reality mindfulness meditation can help women recover better after ACL surgery by reducing fear and improving their movement patterns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 14 Years to 25 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05527171 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of virtual reality mindfulness meditation on women who have undergone anterior cruciate ligament reconstruction (ACLR). It aims to reduce injury-related fear, improve jump-landing movement patterns, and enhance brain activity in participants 6 months to 10 years post-surgery. Participants will engage in an 8-week program of virtual reality mindfulness meditation alongside advanced rehabilitation training, compared to a sham group receiving a placebo intervention. The study focuses on addressing psychological barriers to recovery that are often overlooked in traditional rehabilitation practices.
Who should consider this trial
Good fit: Ideal candidates are females aged 14-25 years who are 6 months to 10 years post-ACLR and exhibit self-reported injury-related fear and poor jump-landing movement quality.
Not a fit: Patients who are male, have recent concussions, or have certain medical conditions or implants that prevent participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and return-to-sport rates for women after ACL reconstruction.
How similar studies have performed: While the use of virtual reality in rehabilitation is emerging, this specific application of mindfulness meditation post-ACLR is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chapel Hill, North Carolina
- Fetzer Hall, 210 South Road — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Shelby E Baez, Ph.D., ATC — UNC-Chapel Hill
- Study coordinator: Shelby E Baez, Ph.D., ATC
- Email: sbaez@unc.edu
- Phone: 910-273-1821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.