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Virtual Reality Mindfulness Meditation After ACL Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Mindfulness Meditation
Virtual Reality Sham
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Neurosciences, Rehabilitation

Eligibility Criteria

14 Years - 25 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Fetzer Hall, 210 South RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

VR Mindfulness Meditation Group

VR Sham Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 25, 2022
Last Updated
September 6, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05527171
Brief Title
Virtual Reality Mindfulness Meditation After ACL Reconstruction
Official Title
Virtual Reality Mindfulness Meditation in Patients After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
Neurosciences, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR Mindfulness Meditation Group
Arm Type
Experimental
Arm 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.
Arm Title
VR Sham Group
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Mindfulness Meditation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Sham
Intervention Description
Participants will be immersed in a virtual environment of their choosing, such as at a beach, forest, or lake.
Primary Outcome Measure Information:
Title
Percentage of participants who were eligible and enrolled in the study
Description
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.
Time Frame
Through study completion, a total of approximately 3 years.
Title
Percentage of participants retained in the study
Description
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.
Time Frame
Through study completion, a total of approximately 8-weeks
Title
Mean Acceptability Survey Score
Description
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.
Time Frame
Collected post-treatment after completion of the intervention/sham at week 8
Title
Change in Injury-related fear as measured by the Tampa Scale of Kinesiophobia-11
Description
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.
Time Frame
Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Secondary Outcome Measure Information:
Title
Change in external knee abduction moment
Description
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.
Time Frame
Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Title
Change in knee flexion excursion
Description
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.
Time Frame
Collected at baseline and post-treatment after completion of the intervention/sham at week 8
Title
Change in Mean percent Blood Oxygen Level Dependent signal in Default Mode Network.
Description
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.
Time Frame
Collected at baseline and post-treatment after completion of the intervention/sham at week 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shelby E Baez, Ph.D., ATC
Phone
910-273-1821
Email
sbaez@unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelby E Baez, Ph.D., ATC
Organizational Affiliation
UNC-Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fetzer Hall, 210 South Road
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelby E Baez, PhD
Email
sbaez@email.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
IPD Sharing 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.

Learn more about this trial

Virtual Reality Mindfulness Meditation After ACL Reconstruction

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