Clinical trial NCT05527171: Virtual Reality Mindfulness Meditation After ACL Reconstruction
Official title: Virtual Reality Mindfulness Meditation in Patients After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: Neurosciences
Rehabilitation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2022-09-02
Enrollment: 48
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 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.

Eligibility 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

Primary outcomes:
measure: Percentage of participants who were eligible and enrolled in the study
timeFrame: Through study completion, a total of approximately 3 years.
measure: Percentage of participants retained in the study
timeFrame: Through study completion, a total of approximately 8-weeks
measure: Mean Acceptability Survey Score
timeFrame: Collected post-treatment after completion of the intervention/sham at week 8
measure: Change in Injury-related fear as measured by the Tampa Scale of Kinesiophobia-11
timeFrame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Secondary outcomes:
measure: Change in external knee abduction moment
timeFrame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
measure: Change in knee flexion excursion
timeFrame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
measure: Change in Mean percent Blood Oxygen Level Dependent signal in Default Mode Network.
timeFrame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Fetzer Hall, 210 South Road
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Shelby E Baez, Ph.D., ATC
role: PRINCIPAL_INVESTIGATOR
References: