NCT05038189

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

August 31, 2021

Last Update Submit

September 13, 2021

Conditions

Non-radiographic Axial SpondyloarthritisAnkylosing Spondylitis

Keywords

Ankylosing Spondylitis,Non-radiographic Axial SpondyloarthritisSpine postureGait

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 months

Secondary Outcomes (7)

  • Stabilometric test

    6 months

  • Bath Ankylosing Spondylitis Metrology Index

    6 months

  • Bath Ankylosing Spondylitis Disease Activity Index

    6 months

  • Lumbopelvic stabilization assessment

    6 months

  • Disease-Related Functional Status

    6 months

  • +2 more secondary outcomes

Study Arms (3)

Ankylosing Spondylitis

EXPERIMENTAL

Study group

Diagnostic Test: Gait parameters

Non-radiographic Axial Spondyloarthritis

EXPERIMENTAL

Study group

Diagnostic Test: Spine posture

Healthy individuals

EXPERIMENTAL

Control group

Diagnostic Test: Trunk position sense

Interventions

Gait parametersDIAGNOSTIC_TEST

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.

Also known as: Trunk position sense, Spine posture
Ankylosing Spondylitis
Spine postureDIAGNOSTIC_TEST

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.

Also known as: Gait parameters, Trunk position sense
Non-radiographic Axial Spondyloarthritis
Trunk position senseDIAGNOSTIC_TEST

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.

Also known as: Gait parameters, Spine posture
Healthy individuals

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin Akkubak

Konya, Meram, 42100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Non-Radiographic Axial SpondyloarthritisSpondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • ADEM KÜÇÜK, Dr.

    Necmettin Erbakan University, Faculty of Medicine, Meram/KONYA/TURKEY

    STUDY CHAIR

Central Study Contacts

YASEMİN AKKUBAK, Res. Asiss.

CONTACT

+905514327535yakkubak@gmail.com

TÜLİN DÜGER, Prof.

CONTACT

+905324714440tduger@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

July 15, 2021

Primary Completion

January 1, 2022

Study Completion

March 1, 2022

Last Updated

September 20, 2021

Record last verified: 2021-09

Locations

TU(1)