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

N/ANot Yet RecruitingNCT07381244

Selcuk University51 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Fibromyalgia Syndrome

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Hand Grip Strength

Hand grip strength will be measured in a seated position following standardized testing posture, with the shoulder adducted and in neutral rotation, the elbow flexed to 90 degrees, the forearm supported in mid-rotation, and the wrist in a neutral position. Measurements will be obtained from the dominant hand using a handheld dynamometer. Participants will be instructed to perform a maximal voluntary contraction. Three trials will be conducted with 15-second rest intervals, and the highest value will be recorded in kilograms (kg).

Time frame: Baseline

Knee extension muscle strength

Knee extension muscle strength will be measured using a handheld dynamometer in a seated position with the hip and knee flexed to 90 degrees. The lower legs will hang freely, and the arms will be crossed over the chest. The dynamometer will be positioned perpendicular to the leg, 1-2 cm proximal to the malleoli, with stabilization applied at the thigh. Three measurements will be obtained, and the highest value will be recorded in kilograms (kg)

Time frame: baseline

Physical Activity Level

Physical activity level will be assessed using the 7-item short form of the International Physical Activity Questionnaire. The questionnaire evaluates time spent sitting, walking, moderate-intensity activities, and vigorous-intensity activities during the previous 7 days. Duration (minutes) and frequency (days) of each activity will be recorded. Total physical activity score will be calculated by multiplying activity duration by the corresponding metabolic equivalent (MET) value and summing all activity scores. Physical activity levels will be classified as physically inactive (\<600 MET-min/week), minimally active (600-3000 MET-min/week), or active (\>3000 MET-min/week).

Time frame: baseline

Single-Leg Balance Test Time

Balance will be assessed using the single-leg balance test under eyes-open and eyes-closed conditions. Participants will stand on the dominant leg with the arms crossed over the chest while the contralateral leg is lifted from the ground with the knee flexed to approximately 45 degrees. Timing will begin once the test position is achieved. The test will be terminated if the arms or the non-stance leg are used for support or when the maximum duration of 30 seconds is reached. Time will be recorded in seconds. Each condition will be repeated three times, and the best performance will be recorded. The same procedure will be applied to the nondominant leg

Time frame: baseline