Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome

NCT07381244 | Not Yet Recruiting

• 1 other identifier: ZKORKUT_fibromiyalji
• Study Type: observational
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fibromyalgia syndrome (FMS) is a chronic rheumatic condition characterized by widespread pain, fatigue, and functional impairments that negatively affect physical activity levels, muscle strength, balance, and functional mobility. These impairments may lead to reduced functional capacity and increased sedentary behavior. Therefore, objective assessment of mobility, balance, and functional performance is essential in individuals with FMS. Performance-based tests such as the Five Times Sit-to-Stand Test (5xSTS) and the Timed Up and Go (TUG) test are commonly used to evaluate lower extremity muscle function, balance, and functional mobility due to their simplicity, feasibility, and clinical relevance. Recently, virtual reality (VR)-based assessment methods have emerged as a standardized and objective approach for evaluating functional performance. This study aims to investigate the feasibility and measurement properties of virtual reality-based adaptations of the 5xSTS and TUG tests in individuals with fibromyalgia syndrome using a head-mounted VR system. Findings from this study are expected to contribute to the clinical use of VR technology in mobility and balance assessment in individuals with FMS.

Conditions

Fibromyalgia Syndrome

Keywords

Validity, reliability; fibromyalgia syndrome; virtual reality

Outcome Measures

Primary Outcomes (1)

• Performans evaluation

  Performance outcomes will be assessed using the Five Times Sit-to-Stand Test (5xSTS) and the Timed Up and Go (TUG) test. These tests are widely used functional performance measures with established validity and reliability. In this study, virtual reality (VR) adaptations of both tests will also be applied. Participants will enter the testing environment using a VR headset, and test protocols will be conducted in the same manner as the conventional applications. The VR-based assessments will follow standardized procedures equivalent to the traditional versions of the 5xSTS and TUG tests.

  Baseline and 7 days later (test-retest interval).

Secondary Outcomes (4)

• Hand Grip Strength

  Baseline

• Knee extension muscle strength

  baseline

• Physical Activity Level

  baseline

• Single-Leg Balance Test Time

  baseline

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include adult individuals diagnosed with fibromyalgia according to established diagnostic criteria. Participants will be recruited from outpatient clinics and through announcements. All participants will be able to walk independently and will voluntarily agree to participate in the study. Demographic and clinical characteristics, physical performance, muscle strength, balance, physical activity level, and pain severity will be assessed.

You may qualify if:

• Having been diagnosed with FMS according to the American Rheumatology Association (ARB) 1990 classification criteria,
• Being female between the ages of 30-60
• Having the cognitive ability to understand the instructions
• Being a volunteer

You may not qualify if:

• Severe physical disability
• Rheumatological/neurological diseases
• Any musculoskeletal problem (fracture, deformity, sprain)
• Malignancy
• Severe cognitive impairment
• Pregnancy

Sponsors & Collaborators

• Selcuk University: lead

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 2, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share