Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06948500

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

Led by Cardenal Herrera University · Updated on 2025-11-18

80

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults diagnosed with fibromyalgia according to any American College of Rheumatology criteria (1990, 2010, 2011, or 2016)
  • Ability to communicate effectively with research staff
  • Self-reported pain intensity of 3 or higher on an 11-point Numerical Pain Rating Scale
Not Eligible

You will not qualify if you...

  • Any health condition that contraindicates immersive virtual reality or exercise interventions
  • Medical issues that may affect study results, including visual, auditory, perceptual, or sensory disorders
  • Use of medications that might impact study outcomes
  • Participation in another therapeutic physical activity program or changes to current therapies during the study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Juan Fco. Lisón

Valencia, Valencia-valència, Spain, 46006

Actively Recruiting

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Research Team

J

JUAN FRANCISCO LISÓN PÁRRAGA, PhD

CONTACT

J

Juan J Amer, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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