Clinical trial NCT05038189: Evaluation of Spine Posture, Trunk Position Sense and Gait in Axial Spondyloarthritis Patients
Official title: Comparison of Spine Posture, Trunk Position Sense and Gait Characteristics Among Different Sub-types of Axial Spondyloarthritis Patients and Healthy Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-radiographic Axial Spondyloarthritis
Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis,
Non-radiographic Axial Spondyloarthritis
Spine posture
Gait
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2021-09-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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,
* 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.

Primary outcomes:
measure: Gait analyses
timeFrame: 6 months
measure: Spine posture
timeFrame: 6 months
measure: Trunk position sense
timeFrame: 6 months
Secondary outcomes:
measure: Stabilometric test
timeFrame: 6 months
measure: Bath Ankylosing Spondylitis Metrology Index
timeFrame: 6 months
measure: Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: 6 months
measure: Lumbopelvic stabilization assessment
timeFrame: 6 months
measure: Disease-Related Functional Status
timeFrame: 6 months
measure: Disease-Related Quality of Life
timeFrame: 6 months
measure: Musculoskeletal Health Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Yasemin Akkubak
state: Meram
Study officials:
affiliation: Necmettin Erbakan University, Faculty of Medicine, Meram/KONYA/TURKEY
name: ADEM KÜÇÜK, Dr.
role: STUDY_CHAIR
References: