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Not yet recruiting NCT07381244

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

Observational Fibromyalgia Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Fibromyalgia Syndrome. Basic parameters: 30 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Performans evaluation [Time frame: Baseline and 7 days later (test-retest interval).]
Secondary outcome measures (4)
  • Hand Grip Strength [Time frame: Baseline]
  • Knee extension muscle strength [Time frame: baseline]
  • Physical Activity Level [Time frame: baseline]
  • Single-Leg Balance Test Time [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07381244 · ZKORKUT_fibromiyalji

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗