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

NCT ID: NCT06245226

Last Updated: 2024-02-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fibromyalgia Chronic Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Baran Tuncer

Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Baran Tuncer, Medical Doctor

Role: CONTACT

+905357605194

Facility Contacts

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Baran Tuncer, Medical Doctor

Role: primary

05357605194

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.

Reference Type RESULT
PMID: 29652782 (View on PubMed)

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.

Reference Type RESULT
PMID: 24755776 (View on PubMed)

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.

Reference Type RESULT
PMID: 19169619 (View on PubMed)

Other Identifiers

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10025142

Identifier Type: -

Identifier Source: org_study_id

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