Anterior Cruciate Ligament InjuryNCT05527171
Virtual Reality Mindfulness Meditation After ACL Reconstruction
A study testing Virtual Reality Mindfulness Meditation in people with Anterior Cruciate Ligament Injury, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 25 years, women only
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Virtual Reality Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fetzer Hall, 210 South Road
Chapel Hill, North Carolina, 27514
Shelby E Baez, PhD, sbaez@email.unc.edu
About this study
Official title: Virtual Reality Mindfulness Meditation in Patients After Anterior Cruciate Ligament Reconstruction
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Virtual Reality Mindfulness Meditation, Virtual Reality Sham
- Keywords
- Neurosciences, Rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Mindfulness MeditationBehavioural
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 ShamBehavioural
Participants will be immersed in a virtual environment of their choosing, such as at a beach, forest, or lake.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Virtual Reality Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Secondary outcomes (3)
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.
Measured: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
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.
Measured: 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.
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.
Measured: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start5 Sep 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Shelby E Baez, Ph.D., ATC, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527171
- Sponsor's protocol ID
- 22-0493
- Other IDs
- K23AR079056
- Status last verified
- Apr 2026
- First submitted
- 25 Aug 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research will include data from all patients regardless of successful completion of the proposed experimental protocol; except if a patient/guardian withdraws their consent. The final dataset will include demographic information, self-reported knee function and injury-related fear questionnaires, biomechanics analysis summaries and raw functional magnetic resonance imaging data. Accompanying the data, a documentation file will be provided containing the methodological procedures used during the collection of the data and providing a key for all variables included within the final dataset. Prior to sharing this data, all personal identifying information will be removed to protect the rights and privacy of the patients.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Mindfulness Meditation in Patients After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05527171
- Acronym / sponsor ID
- 22-0493
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Neurosciences, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Mindfulness Meditation Group | Experimental | Behavioral: Virtual Reality Mindfulness MeditationParticipants 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. |
| VR Sham Group | Sham comparator | Behavioral: Virtual Reality ShamParticipants 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. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Mindfulness MeditationParticipants 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. | Behavioural | VR Mindfulness Meditation Group |
| Virtual Reality ShamParticipants will be immersed in a virtual environment of their choosing, such as at a beach, forest, or lake. | Behavioural | VR Sham Group |
Primary outcome
Percentage of participants who were eligible and enrolled in the study
Time frame: Through study completion, a total of approximately 3 years.
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.
Percentage of participants retained in the study
Time frame: Through study completion, a total of approximately 8-weeks
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.
Mean Acceptability Survey Score
Time frame: Collected post-treatment after completion of the intervention/sham at week 8
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.
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
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.
3 secondary outcomes
Change in external knee abduction moment
Time frame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Change in knee flexion excursion
Time frame: 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.
Time frame: Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. The proposed research will include data from all patients regardless of successful completion of the proposed experimental protocol; except if a patient/guardian withdraws their consent. The final dataset will include demographic information, self-reported knee function and injury-related fear questionnaires, biomechanics analysis summaries and raw functional magnetic resonance imaging data. Accompanying the data, a documentation file will be provided containing the methodological procedures used during the collection of the data and providing a key for all variables included within the final dataset. Prior to sharing this data, all personal identifying information will be removed to protect the rights and privacy of the patients.
Related trials for Anterior Cruciate Ligament Injury
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shelby E Baez, Ph.D., ATC principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Mindfulness Meditation in people with Anterior Cruciate Ligament Injury, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelby E Baez, Ph.D., ATC (910-273-1821, sbaez@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.