Assessment of Posture, Balance, Gait Disorders in Patients With Fibromyalgia
NCT ID: NCT06245226
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-10-15
2024-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Fibromyalgia group
50 female fibromyalgia patients
No interventions assigned to this group
Control group
50 pain-free female volunteers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Signing written informed consent to participate in the study
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Baran Tuncer
Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)
Principal Investigators
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Baran Tuncer, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Health Sciences University, Ankara Bilkent City Hospital
Selami Akkuş, Prof. Dr.
Role: STUDY_CHAIR
Health Sciences University, Ankara Bilkent City Hospital
İpek Poyraz, Pt.
Role: STUDY_CHAIR
Health Sciences University, Ankara Bilkent City Hospital
Locations
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Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Bilkent/Çankaya, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Sempere-Rubio N, Aguilar-Rodriguez M, Espi-Lopez GV, Cortes-Amador S, Pascual E, Serra-Ano P. Impaired Trunk Posture in Women With Fibromyalgia. Spine (Phila Pa 1976). 2018 Nov 15;43(22):1536-1542. doi: 10.1097/BRS.0000000000002681.
Muto LH, Sauer JF, Yuan SL, Sousa A, Mango PC, Marques AP. Postural control and balance self-efficacy in women with fibromyalgia: are there differences? Eur J Phys Rehabil Med. 2015 Apr;51(2):149-54. Epub 2014 Apr 23.
Heredia Jimenez JM, Aparicio Garcia-Molina VA, Porres Foulquie JM, Delgado Fernandez M, Soto Hermoso VM. Spatial-temporal parameters of gait in women with fibromyalgia. Clin Rheumatol. 2009 May;28(5):595-8. doi: 10.1007/s10067-009-1101-7. Epub 2009 Jan 24.
Other Identifiers
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10025142
Identifier Type: -
Identifier Source: org_study_id
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