AzTrials
AzTrials

Fibromyalgia SyndromeNCT07381244

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

An observational study of Fibromyalgia Syndrome, run by Selcuk University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 years, women only
Conditions the study is for
Fibromyalgia Syndrome
How many people
51 participants
Where
No sites listed yet
Study dates
15 Dec 2026to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • • 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

Who cannot join

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

About this study

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.

Keywords
Validity, reliability, fibromyalgia syndrome, virtual reality
Medical subject headings
Fibromyalgia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. 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).

    Measured: Baseline

  2. 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)

    Measured: baseline

  3. 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).

    Measured: baseline

  4. 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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start15 Dec 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381244
Sponsor's protocol ID
ZKORKUT_fibromiyalji
Status last verified
Jan 2026
First submitted
16 Jan 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia Syndrome, run by Selcuk University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performans evaluation (time frame: Baseline and 7 days later (test-retest interval).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07381244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in