Virtual Reality Mindfulness Meditation After ACL Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-25
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: VR Mindfulness Meditation GroupExperimental treatment 1 intervention
Group B: VR Sham GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, a total of approximately 3 years.
2

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.

Time frame
Through study completion, a total of approximately 8-weeks
3

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.

Time frame
Collected post-treatment after completion of the intervention/sham at week 8
4

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.

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

Secondary outcomes

1

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.

Time frame
Collected at baseline and post-treatment after completion of the intervention/sham at week 8
2

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.

Time frame
Collected at baseline and post-treatment after completion of the intervention/sham at week 8
3

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.

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

Other outcomes

Sponsors and contacts

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University of North Carolina, Chapel Hill

Lead sponsor

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

Collaborator