Virtual Reality Mindfulness Meditation After ACL Reconstruction

University of North Carolina (UNC)

Status: Enrolling

Conditions: Anterior Cruciate Ligament Injury

Treatments: Behavioral: Virtual Reality Sham; Behavioral: Virtual Reality Mindfulness Meditation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05527171

K23AR079056 (U.S. NIH Grant/Contract)

22-0493

Details and patient eligibility

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.

Full 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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

VR Mindfulness Meditation Group

Experimental group

Description:

Participants will complete 8-weeks of virtual reality mindfulness meditation and an advanced neuromuscular training program. Mindfulness meditation is the practice of sustaining attention on the body, breath, or sensations in any given moment and allows for the self-regulation of attention by decreasing rumination about past or future events. During the practice of mindfulness meditation, the individual is aware of all incoming thoughts and feelings, but rather than reacting to them, the individual accepts them. Virtual reality mindfulness meditation has been demonstrated to be superior in inducing mindfulness states when compared to traditional mindfulness meditation. Use of a virtual reality system to implement mindfulness meditation not only decreases the barrier of time to implement psychological interventions, but also improves the clinician's confidence in implementing the intervention as the virtual reality system guides the patient through the mindfulness meditation process.

Treatment:

Behavioral: Virtual Reality Mindfulness Meditation

VR Sham Group

Sham Comparator group

Description:

Participants will complete 8-weeks of virtual reality sham and an advanced neuromuscular training program. Participants will be immersed in a virtual environment but will not receive the mindfulness meditation.

Treatment:

Behavioral: Virtual Reality Sham