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

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

May 5, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

February 10, 2027

Conditions
Fibromyalgia
Interventions
OTHER

Immersive Virtual Reality

"Participants will wear an HTC Vive Pro head-mounted display with waist, hand and foot trackers during 60-min sessions, 2 times/week for 6 weeks (12 sessions). A gender- and skin-tone-matched first-person avatar will be calibrated to the user's anthropometrics and will mirror all real-time movements. Standardised audio instructions will be played through the headset; a virtual mirror will provide visual feedback.~To facilitate lumbar mobility, two sensorimotor illusions will be applied: (1) Flexion illusion: Avatar upper-limb length will be reduced by ≈20%, encouraging greater trunk flexion; (2) Extension illusion: A virtual bar will rise with lumbar extension but will under-represent real movement by ≈10%. Both manipulations will update continuously throughout each repetition. A physiotherapist will supervise every session and will record adverse events."

OTHER

Physical Activity

Participants will undertake a 6-week therapeutic exercise program, consisting of two sessions per week (12 sessions total), with a primary objective of reducing fibromyalgia's impact on daily life. Each session will involve ten exercises performed in one or two sets each, depending on the week of the protocol. Exercise repetitions and intensity will be individualized using the Borg Rating of Perceived Exertion (RPE) scale (6-20), maintaining an intensity range of RPE 13-17. Specifically, intensity will start at RPE 14 (moderate) in Weeks 1-2, increase to RPE 15 (moderate-high) in Weeks 3-4, and peak at RPE 16 (high) in Weeks 5-6. No external load will be applied during the first three weeks to allow participants to adapt to the program, while progressive resistance will be introduced during the final three weeks according to individual capacity, ensuring a safe and gradual overload.

Trial Locations (1)

46006

RECRUITING

Juan Fco. Lisón, Valencia

All Listed Sponsors
lead

Cardenal Herrera University

OTHER

NCT06948500 - Effectiveness of an IVR-based Therapeutic Exercise Program With Altered Visual Feedback in Fibromyalgia Patients | Biotech Hunter | Biotech Hunter