Virtual Reality Mindfulness Meditation After ACL Reconstruction

Официальное название

Virtual Reality Mindfulness Meditation in Patients After Anterior Cruciate Ligament Reconstruction

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Percentage of participants who were eligible and enrolled in the study [Срок оценки: Through study completion, a total of approximately 3 years.]
• Percentage of participants retained in the study [Срок оценки: Through study completion, a total of approximately 8-weeks]
• Mean Acceptability Survey Score [Срок оценки: 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 [Срок оценки: Collected at baseline and post-treatment after completion of the intervention/sham at week 8]

Вторичные конечные точки (3)

• Change in external knee abduction moment [Срок оценки: Collected at baseline and post-treatment after completion of the intervention/sham at week 8]
• Change in knee flexion excursion [Срок оценки: 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. [Срок оценки: Collected at baseline and post-treatment after completion of the intervention/sham at week 8]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Fetzer Hall, 210 South Road — Chapel Hill

Идентификаторы

NCT: NCT05527171 · 22-0493 · K23AR079056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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