What side effects are associated with this type of intervention?

Common treatments for Anterior Cruciate Ligament (ACL) injury include surgical options like ACL reconstruction, which can have side effects such as infection, blood clots, knee stiffness, and graft failure. Non-surgical treatments, including physical therapy and rehabilitation exercises, may cause temporary pain or discomfort. Virtual Reality Mindfulness Meditation, aimed at reducing injury-related fear and improving movement patterns, is generally safe with minimal side effects, mainly potential motion sickness or dizziness from the VR experience.

What prior FDA approvals exist?

The FDA has approved various treatments for Anterior Cruciate Ligament (ACL) injuries, primarily focusing on surgical interventions and physical rehabilitation. While there are no specific FDA-approved drugs that directly address injury-related fear, movement patterns, and brain activity through mindfulness practices, treatments such as physical therapy and pain management medications (e.g., NSAIDs) are commonly used. Emerging therapies like Virtual Reality Mindfulness Meditation are being studied for their potential to enhance rehabilitation by reducing fear, improving movement patterns, and positively affecting brain activity, but they are not yet FDA-approved.

What other types of research exist?

<ol> <li>Motor Simulation Therapy: Complements conventional physical rehabilitation by optimizing recovery and safe return to daily life through mental rehearsal of movements.</li> <li></li> </ol> High-Intensity Multicomponent Agility Training: Improves clinical and motor symptoms, potentially enhancing movement patterns and brain activity. 3. Active Music Therapy: Integrates motor and emotional rehabilitation, which can reduce fear and improve movement patterns. 4. Guided Imagery with Progressive Muscle Relaxation: Reduces chronic pain and mobility difficulties, potentially addressing injury-related fear and improving movement patterns.

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Virtual Reality Mindfulness Meditation for ACL Injury

N/A

Recruiting

Led By Shelby E Baez, Ph.D., ATC

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, a total of approximately 3 years.

Awards & highlights

Summary

This trial tests if using virtual reality for mindfulness meditation can help women who had ACL surgery reduce their fear of injury, improve their movements, and enhance brain activity. The study compares this method to another VR experience over a period of time. Virtual Reality (VR) has been increasingly used to enhance mindfulness practices, showing benefits in mental health and engagement.

Who is the study for?

This trial is for females aged 14-25 who had left-side ACL reconstruction surgery 1 to 5 years ago, are right-hand dominant, and injured their knee in sports. They must have MRI compliance, specific levels of fear related to movement (measured by a special scale), and poor jump-landing patterns. Excluded are males, those with recent concussions or CNS medications, claustrophobia, metal implants that can't be removed, under drug influence or pregnant.

What is being tested?

The study tests if virtual reality mindfulness meditation helps reduce injury-related fear, improves jump-landing movements and brain activity after ACL surgery compared to a sham VR experience. Participants will be divided into two groups: one experiencing the meditation VR and the other a fake version.

What are the potential side effects?

Since this trial involves non-invasive interventions like virtual reality experiences rather than drugs or surgeries, significant side effects aren't expected. However, participants might experience discomfort from wearing VR headsets or motion sickness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, a total of approximately 3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, a total of approximately 3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, a total of approximately 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Injury-related fear as measured by the Tampa Scale of Kinesiophobia-11

Mean Acceptability Survey Score

Percentage of participants retained in the study

+1 more

Secondary study objectives

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

Change in external knee abduction moment

Change in knee flexion excursion

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VR Mindfulness Meditation GroupExperimental Treatment1 Intervention

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.

Group II: VR Sham GroupPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ACL injury include surgical reconstruction, physical therapy, and psychological interventions. Surgical reconstruction involves replacing the torn ligament with a graft, which restores knee stability. Physical therapy focuses on strengthening the muscles around the knee, improving flexibility, and retraining movement patterns to prevent re-injury. Psychological interventions, such as mindfulness meditation, aim to reduce injury-related fear and anxiety, which can improve adherence to rehabilitation and overall recovery outcomes. These mechanisms are crucial for ACL injury patients as they address both the physical and psychological aspects of recovery, promoting a holistic approach to healing. The Virtual Reality Mindfulness Meditation trial specifically targets the psychological component by using immersive mindfulness practices to reduce fear, enhance brain activity, and improve movement patterns, which can lead to better rehabilitation outcomes.

Nutrition of the anterior cruciate ligament. Effects of continuous passive motion.The biomechanics of ACL injury: progresses toward prophylactic strategies.

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Who is running the clinical trial?

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

493 Previous Clinical Trials

1,089,382 Total Patients Enrolled

4 Trials studying Anterior Cruciate Ligament Injury

1,376 Patients Enrolled for Anterior Cruciate Ligament Injury

University of North Carolina, Chapel HillLead Sponsor

1,543 Previous Clinical Trials

4,248,994 Total Patients Enrolled

1 Trials studying Anterior Cruciate Ligament Injury

129 Patients Enrolled for Anterior Cruciate Ligament Injury

Shelby E Baez, Ph.D., ATCPrincipal InvestigatorUNC-Chapel Hill

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Virtual Reality Mindfulness Meditation Clinical Trial Eligibility Overview. Trial Name: NCT05527171 — N/A

Anterior Cruciate Ligament Injury Clinical Trial 2023: Virtual Reality Mindfulness Meditation Highlights & Side Effects. Trial Name: NCT05527171 — N/A

Virtual Reality Mindfulness Meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05527171 — N/A

~30 spots leftby May 2026

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