Effectiveness of an IVR-based Therapeutic Exercise Program With Altered Visual Feedback in Fibromyalgia Patients

MI-összefoglaló

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The trial is looking for adults with fibromyalgia who have pain. It tests a 6-week exercise program done with or without virtual reality goggles.

Életkor

18 Years to 80 Years

Nem

All sexes can join

A betegség stádiuma

Fibromyalgia diagnosed by any American College of Rheumatology (ACR) criteria (1990, 2010, 2011 or 2016). Pain score of ≥3 on an 11-point pain scale (NRS-11).

Korábbi kezelés

People cannot change their current treatments, such as medicines or physical therapy, during the study.

A részvétel fő kizáró okai

• Health problems or symptoms that make virtual reality or exercise unsafe
• Problems with sight, hearing, perception or the senses that could affect results
• Taking medicines that could affect study results
• Taking part in another therapeutic exercise program during the study
• Not able to communicate well with the research staff

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 18 és 80 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

The primary aim of this randomized controlled trial is to determine the efficacy of a 6-week immersive virtual reality (IVR)-based therapeutic exercise intervention, which manipulates visual proprioceptive input during exercise, for patients diagnosed with fibromyalgia (FM). Participants will be randomly allocated into two groups: an experimental group performing therapeutic exercises integrated with IVR featuring modified visual feedback, and a control group executing identical exercises without IVR integration. The primary outcome will assess the impact of fibromyalgia on daily activities, while secondary outcomes will comprehensively evaluate fatigue, sleep quality, severity of fibromyalgia symptoms, health-related quality of life, anxiety and depressive symptoms, fear-avoidance beliefs, pain catastrophizing, kinesiophobia, indicators of central sensitization, lumbar spine flexion and extension range of motion, somatosensory function, body perception distortion, muscle strength of the handgrip and quadriceps, functional mobility, lower limb strength, behavioral regulation concerning exercise adherence, and patient-reported experiences regarding IVR use. This trial seeks to elucidate whether incorporating IVR into therapeutic exercise protocols reduces the impact of fibromyalgia on patients' daily lives and improves physiological, psychological, and physical outcomes compared to traditional exercise approaches without IVR.

A vizsgálat 2 csoportja

• Immersive Virtual Reality + Physical ActivityA vizsgált kezelés

  A set of ten therapeutic exercises using IVR will be implemented. These exercises are designed to enhance strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower limbs. During each exercise, participants will wear IVR goggles that modify visual proprioceptive feedback by altering the perceived range of movement. Specifically, the visual input provided by the IVR system will create a discrepancy between actual physical movement and perceived motion, allowing participants to visually experience movements differently from reality.

  Kezelés: Immersive Virtual Reality és Physical Activity

• Physical ActivityMár használt kezelés, összehasonlításként

  Control-group participants will perform the same 6-week therapeutic-exercise program as the experimental group; the only difference will be the absence of the IVR. Training methodology, load progression, assessment procedures, and physiotherapist supervision will remain identical, ensuring comparability between groups.