Virtual Reality Mindfulness Meditation After ACL Reconstruction

Anterior Cruciate Ligament Injury Clinical Trial

Official title:

Virtual Reality Mindfulness Meditation in Patients After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527171
• Other study ID #: 22-0493
• Secondary ID: K23AR079056
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Shelby E Baez, Ph.D., ATC
• Phone: 910-273-1821
• Email: sbaez[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 1 to 5 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 1 to 5 years post ACLR who undergo virtual reality mindfulness meditation will demonstrate decreased injury-related fear, improved jump-landing movement patterns, and improved brain activity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 25 Years

Eligibility

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)
• Have a history of unilateral left-side ACLR
• Right-hand dominant
• 1 to 5-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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury

Intervention

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

Locations

Country	Name	City	State
United States	Fetzer Hall, 210 South Road	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who were eligible and enrolled in the study	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.	Through study completion, a total of approximately 3 years.
Primary	Percentage of participants retained in the study	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.	Through study completion, a total of approximately 8-weeks
Primary	Mean Acceptability Survey Score	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.	Collected post-treatment after completion of the intervention/sham at week 8
Primary	Change in Injury-related fear as measured by the Tampa Scale of Kinesiophobia-11	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.	Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Secondary	Change in external knee abduction moment	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.	Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Secondary	Change in knee flexion excursion	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.	Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Secondary	Change in Mean percent Blood Oxygen Level Dependent signal in Default Mode Network.	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.	Collected at baseline and post-treatment after completion of the intervention/sham at week 8