FibromyalgiaNCT06245226
Assessment of Posture, Balance, Gait Disorders in Patients With Fibromyalgia
An observational study of Fibromyalgia and Chronic Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria
- Signing written informed consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Bilkent/Çankaya, 06800
Baran Tuncer, Medical Doctor, 05357605194, drbarantuncer@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Fibromyalgia, Posture, Postural stability, Balance, Gait
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia group | 50 female fibromyalgia patients | |
| Control group | 50 pain-free female volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Fibromyalgia Impact Questionnaire (FIQ)
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.
Measured: Baseline
Pittsburg Sleep Quality Index (PSQI)
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.
Measured: Baseline
Fatigue Severity Scale (FSS)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Oct 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baran Tuncer, Ankara City Hospital Bilkent
- Investigators
- Baran Tuncer, Medical Doctor, Principal investigator, Health Sciences University, Ankara Bilkent City HospitalSelami Akkuş, Prof. Dr., Study chair, Health Sciences University, Ankara Bilkent City Hospitalİpek Poyraz, Pt., Study chair, Health Sciences University, Ankara Bilkent City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245226
- Sponsor's protocol ID
- 10025142
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29652782Muto 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.
PubMed 24755776Heredia 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.
PubMed 19169619
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Posture, Balance, Gait Disorders in Patients With Fibromyalgia and Investigation of Their Relationships With Disease-related Parameters
- ClinicalTrials.gov ID
- NCT06245226
- Acronym / sponsor ID
- 10025142
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Fibromyalgia, Posture, Postural stability, Balance, Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia group | – | –50 female fibromyalgia patients |
| Control group | – | –50 pain-free female volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria
- Signing written informed consent to participate in the study
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
3 secondary outcomes
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Baseline
Pittsburg Sleep Quality Index (PSQI)
Time frame: Baseline
Fatigue Severity Scale (FSS)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Results publication: PubMed 29652782Sempere-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.
- Results publication: PubMed 24755776Muto 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.
- Results publication: PubMed 19169619Heredia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baran Tuncer, Medical Doctor principal investigator
Health Sciences University, Ankara Bilkent City Hospital
Selami Akkuş, Prof. Dr. study chair
Health Sciences University, Ankara Bilkent City Hospital
İpek Poyraz, Pt. study chair
Health Sciences University, Ankara Bilkent City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Chronic Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baran Tuncer, Medical Doctor (+905357605194, drbarantuncer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posture (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06245226, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.