Virtual Reality Mindfulness Meditation After ACL Reconstruction

NCT05527171 | Recruiting DMC

• 2 other identifiers: 22-0493K23AR079056
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Neurosciences; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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.

• 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

• 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

• 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 Outcomes (3)

• Change in external knee abduction moment

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

• Change in knee flexion excursion

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

• Change in Mean percent Blood Oxygen Level Dependent signal in Default Mode Network.

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

Study Arms (2)

VR Mindfulness Meditation Group

EXPERIMENTAL

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.

Behavioral: Virtual Reality Mindfulness Meditation

VR Sham Group

SHAM COMPARATOR

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.

Behavioral: Virtual Reality Sham

Interventions

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.

VR Mindfulness Meditation Group

Virtual Reality Sham BEHAVIORAL

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

VR Sham Group

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• months to 10-years post-ACLR
• Demonstrate magnetic resonance imaging (MRI) compliance

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Fetzer Hall, 210 South Road

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Shelby E Baez, Ph.D., ATC

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelby E Baez, Ph.D., ATC

CONTACT

910-273-1821; sbaez@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 2, 2022
• Study Start: September 5, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• Access Criteria: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. To further protect the privacy and confidentiality of the data, the data and associated documentation will be made available only under a data-sharing agreement that provides for: (1) requirements to protect patients' privacy and data confidentiality including appropriate data security; (2) restrictions for the transferring of data to others; (3) commitments that the data will be used for research purposes only and not for a profit-making enterprise, and (4) prohibition of manipulation of data for the purposes of attempting to identify research participants.

Locations

US (1)