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

NCT06245226 | Unknown

• 1 other identifier: 10025142
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Chronic Pain

Keywords

Fibromyalgia; Posture; Postural stability; Balance; Gait

Outcome Measures

Primary Outcomes (3)

• Posture

  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

  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

  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 Outcomes (3)

• Fibromyalgia Impact Questionnaire (FIQ)

  Baseline

• Pittsburg Sleep Quality Index (PSQI)

  Baseline

• Fatigue Severity Scale (FSS)

  Baseline

Study Arms (2)

Fibromyalgia group

50 female fibromyalgia patients

Control group

50 pain-free female volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Bilkent/Çankaya, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 29652782 RESULT

• 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.

  PMID: 24755776 RESULT

• 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.

  PMID: 19169619 RESULT

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Baran Tuncer, Medical Doctor

  Health Sciences University, Ankara Bilkent City Hospital

  PRINCIPAL INVESTIGATOR

• Selami Akkuş, Prof. Dr.

  Health Sciences University, Ankara Bilkent City Hospital

  STUDY CHAIR

• İpek Poyraz, Pt.

  Health Sciences University, Ankara Bilkent City Hospital

  STUDY CHAIR

Central Study Contacts

Baran Tuncer, Medical Doctor

CONTACT

+905357605194; drbarantuncer@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: February 7, 2024
• Study Start: October 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-01

Locations

TU (1)