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

Study acronym: IVR-F
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 1 wordv5
  2. Minor Secondary endpoints revised (22)
    • Eligibility criteria expanded, about 1 word
    v4
  3. Notable Start date: Apr 1, 2025 to May 5, 2025
    • Study completion date: Dec 10, 2026 to Feb 10, 2027
    v3
  4. Minor Eligibility criteria revised
    • Secondary endpoints: details revised at 16 of 22 entries
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06948500
Lead Sponsor Cardenal Herrera University
Conditions
(from sponsor)
Fibromyalgia
Related terms Fibromyalgia, Motor Activity, Pain
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov