Assessment of Posture, Balance, Gait Disorders in Patients With Fibromyalgia

February 3, 2024 updated by: Baran Tuncer, Ankara City Hospital Bilkent

Assessment of Posture, Balance, Gait Disorders in Patients With Fibromyalgia and Investigation of Their Relationships With Disease-related Parameters

The study aims to determine the posture, balance and gait disorders objectively in patients with fibromyalgia (FM) and to investigate their relationships with disease-related parameters.

Study Overview

Status

Recruiting

Conditions

Detailed Description

After being informed about study and potential risks, all participants giving written informed consent will undergo screening period determine eligibility for study entry. The participants who met the eligibility recruitments will get into the assessment.

The study will include 100 participants aged between 18-65 years and without any disease or orthopedic disorder that can cause posture, balance and gait disorders: 50 female patients who met the ACR (American College of Rheumatology) 2016 FM diagnostic criteria and 50 pain-free females.

Researcher will record sociodemographic data of all participants and disease duration of patients with FM. The researcher will evaluate disease activity by Fibromyalgia Impact Questionnaire, sleep quality by Pittsburgh Sleep Quality Index and fatigue severity by Fatigue Severity Scale in FM group.

In both groups the researcher will use; DIERS formetric 3D/4D video-rasterstereography (Diers International GmbH, Schlangenbad, Germany) device for the posture analyze, HUR SmartBalance BTG4 system (Hur Labs, Kokkola, Finland) for postural balance control and limits of stability measurements, Zebris FDM type 3 (Zebris Medical GmbH, Germany) gait analysis system for measuring spatio-temporal gait parameters.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Bilkent/Çankaya
      • Ankara, Bilkent/Çankaya, Turkey, 06800
        • Recruiting
        • Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

100 participants aged between 18-65 years: 50 female patients who met the ACR 2016 FM diagnostic criteria and 50 pain-free females.

Description

Inclusion Criteria:

  • Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria
  • Signing written informed consent to participate in the study

Exclusion Criteria:

  • Rheumatological, neurological and/or psychiatric diseases that may cause balance and gait disorders (cerebrovascular accident sequelae, Parkinson's, myasthenia gravis, polyneuropathy, rheumatoid arthritis, ankylosing spondylitis, major depression)
  • Other diseases that cause balance and other gait disorders (history of major trauma to the lower extremity, and/or orthosis users, those who have had spinal and/or lower extremity surgery)
  • Orthopedic disorders that may cause limitation in joint range of motion and/or loss of motor muscle strength
  • Those who cannot take commands due to cognitive dysfunction
  • Vestibular and/or cerebellar disorders
  • Abnormal ophthalmic/optometric disorder (vision disorders)
  • Pregnancy
  • Serious cardiac disease, malignancy and renal failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Fibromyalgia group
50 female fibromyalgia patients
Control group
50 pain-free female volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posture
Time Frame: Baseline

Posture analysis will be evaluated by DIERS Formetric 4D (Diers International GmbH, Schlangenbad, Germany). Participants will be positioned two meters away from the projector. The slide projector projects a series of parallel light strips on the back of the participant. The back's surface will be captured on camera converted to digital data, and displayed in three dimensions. Every scan will record 12 images over 6 seconds (2Hz) and the manufacturer's recommendations will be followed for processing.

Spinal reference points, measures of the spinal curves, distance and localization, imbalances of the trunk and pelvis and spinal deviation will be measured. Spine parameters are expressed in millimeters, percentages or degrees depending on the specific parameter.
Baseline
Balance
Time Frame: Baseline
The static and dynamic postural control will be measured by HUR SmartBalance BTG4 system (Hur Labs, Tampere, Finland). Participants will be asked to stand barefoot on the balance platform and to stand as quietly as possible, looking forward, during the measurement. While the stable surface is the platform's own floor, the unstable surface is the foam cushion provided by the manufacturer with the device. Data will be collected for 30 seconds. The following parameters will be calculated from the center of pressure (CoP) displacement time series for static postural control: sway area, velocity, Romberg. The limits of stability (LOS) was used to evaluate the dynamic postural control. The participants were asked to tilt their bodies forward, backward, leftward, and rightward for 8 seconds in each direction on the same platform.
Baseline
Gait
Time Frame: Baseline
Spatio-temporal gait analysis was performed by Zebris FDM type 3 (Zebris Medical GmbH, Germany) gait analysis system. The system consists of a 3 meters long main platform which contains sensors for measuring the force distributions and a 1 meters long maneuvering platforms that located at the beginning and end of the main platform. Participants will be asked to walk barefoot on the platform. Each participant will walk at their comfortable speed for 2 minutes continuously going from one end to the other along a 5-m walkway in a quiet, well-lit room. The main platform was located in the middle of the system in order to avoid the unstable walking periods on turns. The data were analyzed and recorded on the computer. Foot rotation, stride length, step width, double limb support phase, cadance will be measured. Gait parameters are expressed in centimeters, percentages or degrees depending on the specific parameter.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: Baseline
In FM group; Fibromyalgia Impact Questionnaire (FIQ) will be used to measure the impact of FM on patient's physical function, health status and the severity of disease activity. FIQ is scored from 0-100. Higher scores indicate increased severity of the impact of FM.
Baseline
Pittsburg Sleep Quality Index (PSQI)
Time Frame: Baseline
Pittsburg Sleep Quality Index (PSQI) will be used to evaluate sleep quality and the presence of sleep disturbance. The total score consists of 7 components. These components consist of a single question or a combination of several questions. Each question is evaluated on a 0-3 point scale. The total score is between 0-21. A high score indicates poor sleep quality.
Baseline
Fatigue Severity Scale (FSS)
Time Frame: Baseline
Fatigue Severity Scale (FSS) will be used to assess fatigue level. The scale consists of 9 questions. Participants are questioned about the level of fatigue in the last week. The questions are scored between 1-7. 1 point: "strongly disagree" and 7 points: "strongly agree", scaled as a Likert-type scale where the degree of agreement increases as the points increase. The highest possible score is 7. Scores of 4 and above indicate pathological fatigue.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Baran Tuncer, Medical Doctor, Health Sciences University, Ankara Bilkent City Hospital
  • Study Chair: Selami Akkuş, Prof. Dr., Health Sciences University, Ankara Bilkent City Hospital
  • Study Chair: İpek Poyraz, Pt., Health Sciences University, Ankara Bilkent City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

February 3, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10025142

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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