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

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Description

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.

Targeted Conditions

Study Overview

Start Date
October 15, 2023
Completion Date
April 1, 2024
Enrollment
100
Date Posted
February 7, 2024
Accepts Healthy Volunteers?
Yes
Gender
Female

Locations

Full Address
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Bilkent/Çankaya 06800, Turkey

Eligibility

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.
Minimum Age (years)
18
Maximum Age (years)
65
Eligibility Criteria
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 Contact Info

Study Contact Name
Baran Tuncer, Medical Doctor
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT06245226