Recruiting

Virtual Reality

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05527171

Conditions

Anterior Cruciate Ligament Injury

Eligibility Criteria

Sex: Female

Age: 14 - 25

Healthy Volunteers: Not accepted

Interventions

Virtual Reality Mindfulness Meditation

Virtual Reality Sham

Study Details

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.

Conditions

Anterior Cruciate Ligament Injury

Study ID

NCT05527171

Start date

Sep 5, 2023

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VR Mindfulness Meditation Group

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.

sham comparator: VR Sham Group

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.

Interventions

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.

Primary outcome measure

  • Percentage of participants who were eligible and enrolled in the study [ Time Frame: Through study completion, a total of approximately 3 years. ]
  • Percentage of participants retained in the study [ Time Frame: Through study completion, a total of approximately 8-weeks ]
  • Mean Acceptability Survey Score [ Time Frame: Collected post-treatment after completion of the intervention/sham at week 8 ]
  • Change in Injury-related fear as measured by the Tampa Scale of Kinesiophobia-11 [ Time Frame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8 ]

Central Contacts and Locations

Central contacts

Shelby E Baez, Ph.D., ATC

910-273-1821sbaez@unc.edu

Locations

Fetzer Hall, 210 South Road

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Shelby E Baez, PhD

sbaez@email.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Aug 17, 2026

Last verified

Apr, 2026

Keywords

  • Neurosciences
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-08-17.