Non-radiographic Axial SpondyloarthritisNCT05038189
Evaluation of Spine Posture, Trunk Position Sense and Gait in Axial Spondyloarthritis Patients
A study testing Gait parameters, Spine posture and Trunk position sense in people with Non-radiographic Axial Spondyloarthritis and Ankylosing Spondylitis, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Axial Spondyloarthritis (Ax-SpA) are chronic systemic inflammatory rheumatological diseases characterized by axial skeletal involvement and enthesitis. Sacroiliitis is the most prominent sign of the disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis
- What is being tested?
- Gait parameters, Spine posture and Trunk position sense
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to Mar 2022
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For AS and nr-axSpA;
- Diagnosed with AS and nr-axSpA by a rheumatologist according to ASAS criteria,
- Diagnosed with AS and nr-axSpA at least two years ago,
- Volunteer to participate in the study,
- Individuals between the ages of 18-65 will be included in the study.
- For Healthy volunteers;
- Volunteer to participate in the study,
- Individuals between the ages of 18-65 will be included in the study.
Who cannot join
- For AS and nr-axSpA;
- Having orthopedic problems in the lower extremity,
- Locomotor disorders (fractures and prostheses) and / or osteoporosis,
- Having a history of lower extremity and spine surgery,
- Having neurological and cognitive problems,
- Having vision and hearing problems,
Show all 13Show fewer
- Regular exercise,
- Individuals with kyphosis above 50 degrees will be excluded from the study.
- For Healthy volunteers;
- Having any musculoskeletal, neurological and rheumatological diseases,
- Having any condition (advanced respiratory or orthopedic problems, fracture, sprain or spine surgery) that will prevent the evaluation,
- Regular exercise,
- Individuals who do not agree to participate in the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yasemin Akkubak
Konya, Meram, 42100
YASEMİN AKKUBAK, Res. Assist., 05514327535, yakkubak@gmail.com
ADEM KÜÇÜK, Dr., 05514327535, drademk@gmail.com
About this study
Official title: Comparison of Spine Posture, Trunk Position Sense and Gait Characteristics Among Different Sub-types of Axial Spondyloarthritis Patients and Healthy Controls
Axial Spondyloarthritis (Ax-SpA) are chronic systemic inflammatory rheumatological diseases characterized by axial skeletal involvement and enthesitis. Sacroiliitis is the most prominent sign of the disease. The International Society for the Evaluation of Spondyloarthritis created a new classification for Ax-SpA in 2009. According to this classification, Ax-SpA; It is divided into two groups as ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
With the emergence of the term nr-axSpA, studies have begun to compare AS and nr-axSpA in terms of genetic, epidemiological and clinical features, treatment needs and response to treatment.However, more studies are needed to better understand the clinical features and symptoms of nr-axSpA patients.
The aim of this study was to determine the clinical features of patients with nr-axSpA and AS; To evaluate spine posture, trunk position sense and gait parameters, and also to compare these results with healthy individuals.
Read the detailed description
There are no studies comparing spine posture, trunk position sense and gait parameters in patients with nr-axSpA and AS. It is important to determine the changes that occur in nr-axSpA patients in the early period. At the same time, taking the necessary precautions and following these patients with the rehabilitation process can ensure that the radiographic development is delayed or not at all in the future.
Hypotheses:
H1: Trunk position sense is different from each other in individuals with Nr-axSpA and AS.
H2: Spatio-temporal features of gait are different in individuals with Nr-axSpA and AS.
H3: Plantar pressure distribution is different in individuals with Nr-axSpA and AS.
The Location of the Research: The research is carried out in Konya Necmettin Erbakan University Meram Faculty of Medicine, Rheumatology Department. After obtaining the permission of the ethics committee, official permission was obtained from Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician to conduct the study.
- Being tested
- Gait parameters, Spine posture, Trunk position sense
- Keywords
- Ankylosing Spondylitis,, Non-radiographic Axial Spondyloarthritis, Spine posture, Gait
- Medical subject headings
- Non-Radiographic Axial Spondyloarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait parametersDiagnostic test
Also called Trunk position sense, Spine posture
Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
Spine postureDiagnostic test
Also called Gait parameters, Trunk position sense
Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
Trunk position senseDiagnostic test
Also called Gait parameters, Spine posture
Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing Spondylitis | Experimental | Study group Receives: Diagnostic Test: Gait parameters |
| Non-radiographic Axial Spondyloarthritis | Experimental | Study group Receives: Diagnostic Test: Spine posture |
| Healthy individuals | Experimental | Control group Receives: Diagnostic Test: Trunk position sense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analyses
The spatiotemporal parameters of gait will be evaluated using the Diagnostic Support Baropodometer Footscan® 3D system. The spatial parameters of gait, step length (cm), step width (cm) and foot angle (degrees) and the temporal parameters of gait, speed (m/min), cadence (step/min) and stance time (sec) will be recorded. For evaluating of the plantar pressure distribution will be used the Diagnostic Support Baropodometer Footscan® 3D system, besides the dynamic evaluation and recording of the spatiotemporal parameters, the data on the total load on the forefoot, midfoot and hindfoot; the average pressure; and the distribution of load in the forefoot, midfoot and hindfoot will be also obtained.
Measured: 6 months
Spine posture
Thoracic and lumbar curvature tests will be performed with a digital inclinometer (Acumar®, Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). For throcic curvature, the 7th cervical vertebra, the most prominent spinous process, and the sacrum will be used as reference points to palpate the spinal processes of T1-T2 and T12-L1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T1-T2 and T12-L1. The angle on the digital display of the inclinometer will be recorded as degree. The mean of three successful measurements will be used. For lumbar curvature, the sacrum and iliac crest will be used as reference points to palpate the spinal processes of T12-L1 and L5-S1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T12-L1 and L5-S1. The angle on the digital display of the inclinometer will be recorded in degrees.
Measured: 6 months
Trunk position sense
Trunk position sense, as indicated by trunk reposition errors (TRE), will be assessed with a digital inclinometer (Acumar®,Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). The participants will be asked to stand upright in a comfortable position. The inferior angle of the scapula will first palpated as a bony landmark to find the spinousprocess of T4. After the placement of the inclinometer over the spinous process of T4, the participants will be asked to flex the trunk approximately 30° in the sagittal plane and hold this position for 3 s in eyes closed position. After returning to the neutral upright position, they will be asked to duplicate the previously attained position and held the position for 3 s for five times in a row. The absolute differences between the original position and the other five attempts will be recorded. The highest and lowest scores will be discarded and the mean of the tree remaining scores will be used to assess the trunk position sense.
Measured: 6 months
Secondary outcomes (7)
Stabilometric test
In the stabilometric evaluation, a STABYLO platform, which is produced by Diagnostic Support, will be used. A 40x80 cm sensing surface with 12,800 active sensors is used for the examination of body oscillations in the upright position (the foot at 30°) and for the evaluation of body strategies in a specific time frame (maximum 51.2 sec) by maintaining the eyes in the open and closed positions. In the present study, the body oscillations with open and closed eyes will be calculated as an area in cm².
Measured: 6 months
Bath Ankylosing Spondylitis Metrology Index
Spinal mobility will assessed and scored by Bath Ankylosing Spondylitis Metrology Index (BASMI). There are five measurements including lateral lumbar flexion, tragus-to-wall distance, lumbar flexion (Modified Schober), maximal intermalleolar distance and cervical rotation according to the index. Each subscale is scored between 0 and 10. All points are then averaged to calculate total score. Higher values represent worse outcomes.
Measured: 6 months
Bath Ankylosing Spondylitis Disease Activity Index
Bath Ankylosing Spondylitis Disease Activity Index which consists of 6 questions will be used to evaluate disease activity. BASDAI is a composite index, consisting of an assessment on a 10 cm horizontal visual analog scale of fatigue, axial pain, peripheral pain, enthesopathy and stiffness. Fifth and sixth questions are averaged. Addition to this score, other questions are averaged. Total score is between 0 and 10. Higher score represent worse outcome.
Measured: 6 months
Lumbopelvic stabilization assessment
Lumbopelvic stabilization will be evaluated by a pressure biofeedback unit (Stabilizer Pressure Biofeedback Unit, Chattanooga Group Inc., Hixson, TN, USA). The participant will be positioned in crook lying position and the pressure cell will be placed under the lumbar spine and inflate to the baseline pressure of 40 mmHg. The participant will be instructed to perform abdominal hollowing without moving their spine or pelvis, and to hold the contraction for 10 seconds monitored by using a digital watch. The change in pressure during abdominal hollowing will be repeated three times and the mean of all the measurements will be recorded.
Measured: 6 months
Disease-Related Functional Status
Bath Ankylosing Spondylitis Functional Index (BASFI) was used to assess the functional status. BASFI includes 10 items which eight of them related to physical limitations, and two of them inquiry about the coping strategies in daily life. Each item is scored between 0 and 10 (0: easy, 10: impossible) by the patient. The total score is calculated by summing all the items and dividing them to 10. Higher scores indicate a higher level of functional limitations.
Measured: 6 months
Disease-Related Quality of Life
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) will be used to evaluate the disease-related quality of life. It includes 18 yes/no questions. Each yes answer is scored as onepoint. ASQoL is a valid and reliable tool for both clinical purposes and scientific research. Higher scores indicate poorer quality of life.
Measured: 6 months
Musculoskeletal Health Questionnaire
The Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) is composed of 14 items which evaluate the holistic impact of different musculoskeletal diseases on a person's health over the last two weeks, regardless of the location of their musculoskeletal pain. These items consist of the severity of stiffness/pain (during the day and night), physical function (washing/dressing and walking), level of physical activity, symptom interference (with daily routine, work and social activities), needing help, trouble with sleeping, low energy/fatigue level, emotional well-being (mood and anxiety), understanding of treatment and diagnosis, confidence to self-management, independence and general impact of symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start15 Jul 2021
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-radiographic Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, YASEMİN AKKUBAK, Necmettin Erbakan University
- Investigators
- ADEM KÜÇÜK, Dr., Study chair, Necmettin Erbakan University, Faculty of Medicine, Meram/KONYA/TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038189
- Sponsor's protocol ID
- PhD_Yakkubak
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spine Posture, Trunk Position Sense and Gait Characteristics Among Different Sub-types of Axial Spondyloarthritis Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT05038189
- Acronym / sponsor ID
- PhD_Yakkubak
- Keywords
- Ankylosing Spondylitis,, Non-radiographic Axial Spondyloarthritis, Spine posture, Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 8 Sep 2021 (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.
Axial Spondyloarthritis (Ax-SpA) are chronic systemic inflammatory rheumatological diseases characterized by axial skeletal involvement and enthesitis. Sacroiliitis is the most prominent sign of the disease. The International Society for the Evaluation of Spondyloarthritis created a new classification for Ax-SpA in 2009. According to this classification, Ax-SpA; It is divided into two groups as ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
With the emergence of the term nr-axSpA, studies have begun to compare AS and nr-axSpA in terms of genetic, epidemiological and clinical features, treatment needs and response to treatment.However, more studies are needed to better understand the clinical features and symptoms of nr-axSpA patients.
The aim of this study was to determine the clinical features of patients with nr-axSpA and AS; To evaluate spine posture, trunk position sense and gait parameters, and also to compare these results with healthy individuals.
Detailed description
There are no studies comparing spine posture, trunk position sense and gait parameters in patients with nr-axSpA and AS. It is important to determine the changes that occur in nr-axSpA patients in the early period. At the same time, taking the necessary precautions and following these patients with the rehabilitation process can ensure that the radiographic development is delayed or not at all in the future.
Hypotheses:
H1: Trunk position sense is different from each other in individuals with Nr-axSpA and AS.
H2: Spatio-temporal features of gait are different in individuals with Nr-axSpA and AS.
H3: Plantar pressure distribution is different in individuals with Nr-axSpA and AS.
The Location of the Research: The research is carried out in Konya Necmettin Erbakan University Meram Faculty of Medicine, Rheumatology Department. After obtaining the permission of the ethics committee, official permission was obtained from Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician to conduct the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ankylosing Spondylitis | Experimental | Diagnostic Test: Gait parametersStudy group |
| Non-radiographic Axial Spondyloarthritis | Experimental | Diagnostic Test: Spine postureStudy group |
| Healthy individuals | Experimental | Diagnostic Test: Trunk position senseControl group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For AS and nr-axSpA;
- Diagnosed with AS and nr-axSpA by a rheumatologist according to ASAS criteria,
- Diagnosed with AS and nr-axSpA at least two years ago,
- Volunteer to participate in the study,
- Individuals between the ages of 18-65 will be included in the study.
Key exclusion criteria (13 listed)
- For AS and nr-axSpA;
- Having orthopedic problems in the lower extremity,
- Locomotor disorders (fractures and prostheses) and / or osteoporosis,
- Having a history of lower extremity and spine surgery,
- Having neurological and cognitive problems,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait parametersAlso: Trunk position sense, Spine postureTrunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated. | Diagnostic test | Ankylosing Spondylitis |
| Spine postureAlso: Gait parameters, Trunk position senseTrunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated. | Diagnostic test | Non-radiographic Axial Spondyloarthritis |
| Trunk position senseAlso: Gait parameters, Spine postureTrunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated. | Diagnostic test | Healthy individuals |
Primary outcome
Gait analyses
Time frame: 6 months
The spatiotemporal parameters of gait will be evaluated using the Diagnostic Support Baropodometer Footscan® 3D system. The spatial parameters of gait, step length (cm), step width (cm) and foot angle (degrees) and the temporal parameters of gait, speed (m/min), cadence (step/min) and stance time (sec) will be recorded. For evaluating of the plantar pressure distribution will be used the Diagnostic Support Baropodometer Footscan® 3D system, besides the dynamic evaluation and recording of the spatiotemporal parameters, the data on the total load on the forefoot, midfoot and hindfoot; the average pressure; and the distribution of load in the forefoot, midfoot and hindfoot will be also obtained.
Spine posture
Time frame: 6 months
Thoracic and lumbar curvature tests will be performed with a digital inclinometer (Acumar®, Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). For throcic curvature, the 7th cervical vertebra, the most prominent spinous process, and the sacrum will be used as reference points to palpate the spinal processes of T1-T2 and T12-L1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T1-T2 and T12-L1. The angle on the digital display of the inclinometer will be recorded as degree. The mean of three successful measurements will be used. For lumbar curvature, the sacrum and iliac crest will be used as reference points to palpate the spinal processes of T12-L1 and L5-S1, respectively. The feet of the inclinometers will be placed as simultaneously as possible over T12-L1 and L5-S1. The angle on the digital display of the inclinometer will be recorded in degrees.
Trunk position sense
Time frame: 6 months
Trunk position sense, as indicated by trunk reposition errors (TRE), will be assessed with a digital inclinometer (Acumar®,Dual Digital Inclinometer, Lafayette Instrument Company, IN, USA). The participants will be asked to stand upright in a comfortable position. The inferior angle of the scapula will first palpated as a bony landmark to find the spinousprocess of T4. After the placement of the inclinometer over the spinous process of T4, the participants will be asked to flex the trunk approximately 30° in the sagittal plane and hold this position for 3 s in eyes closed position. After returning to the neutral upright position, they will be asked to duplicate the previously attained position and held the position for 3 s for five times in a row. The absolute differences between the original position and the other five attempts will be recorded. The highest and lowest scores will be discarded and the mean of the tree remaining scores will be used to assess the trunk position sense.
7 secondary outcomes
Stabilometric test
Time frame: 6 months
Bath Ankylosing Spondylitis Metrology Index
Time frame: 6 months
Bath Ankylosing Spondylitis Disease Activity Index
Time frame: 6 months
Lumbopelvic stabilization assessment
Time frame: 6 months
Disease-Related Functional Status
Time frame: 6 months
Disease-Related Quality of Life
Time frame: 6 months
Musculoskeletal Health Questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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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.
ADEM KÜÇÜK, Dr. study chair
Necmettin Erbakan University, Faculty of Medicine, Meram/KONYA/TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait parameters, Spine posture and Trunk position sense in people with Non-radiographic Axial Spondyloarthritis and Ankylosing Spondylitis, run by Necmettin Erbakan University 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 8 inclusion and 13 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 20 Sep 2021. 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 YASEMİN AKKUBAK, Res. Asiss. (+905514327535, yakkubak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait analyses (time frame: 6 months). 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?
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 20 Sep 2021.