NCT04820725

Brief Summary

Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. The purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in AS patients and to compare AS patients with and without postural changes and healthy subjects.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

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

First Submitted

Initial submission to the registry

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 31, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2022

Completed
Last Updated

March 29, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

March 25, 2021

Last Update Submit

March 25, 2021

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis,postureplantar pressure

Outcome Measures

Primary Outcomes (1)

  • Gait analyses

    plantar pressure distribution

    3 minutes

Secondary Outcomes (3)

  • Bath Ankylosing Spondylitis Metrology Index

    5 minutes

  • Bath Ankylosing Spondylitis Disease Activity Index

    1 minute

  • Time up and go test

    1 minute

Study Arms (2)

Study group

EXPERIMENTAL

Patients whose BASMI score is 2 will be included in the study

Diagnostic Test: Plantar pressure and gait

Control group

EXPERIMENTAL

Patients whose BASMI score is 0 and 1 will be included in the study

Diagnostic Test: Plantar pressure and gait

Interventions

Plantar pressure and gaitDIAGNOSTIC_TEST

Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated using Win-Track platform (MEDICAPTEURS Technology, France).

Control groupStudy group

Eligibility Criteria

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

You may qualify if:

  • Patients who are aged between 18-55 years,
  • Patients who got diagnosed according to Modified New York criteria
  • Patients who are being followed at Firat University Department of Rheumatology.

You may not qualify if:

  • Patients who have exercise habits
  • Incooperation
  • Malignancy
  • Pregnancy
  • Patients who have changes of medical treatment in the last 3 months
  • Patients who have another disease that can effect pulmonary functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Sahli H, Bachali A, Tekaya R, Mahmoud I, Sedki Y, Saidane O, Abdelmoula L. Involvement of foot in patients with spondyloarthritis: Prevalence and clinical features. Foot Ankle Surg. 2019 Apr;25(2):226-230. doi: 10.1016/j.fas.2017.10.016. Epub 2017 Nov 10.

    PMID: 29409278BACKGROUND

  • Aydin E, Turan Y, Tastaban E, Kurt Omurlu I, Sendur OF. Plantar pressure distribution in patients with ankylosing spondylitis. Clin Biomech (Bristol). 2015 Mar;30(3):238-42. doi: 10.1016/j.clinbiomech.2015.02.003. Epub 2015 Feb 8.

    PMID: 25684149BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Gait

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Süleyman S Koca

    Firat University

    STUDY DIRECTOR

Central Study Contacts

Songul B Yentur

CONTACT

0424 237 8282songulbaglan23@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 29, 2021

Study Start

October 31, 2021

Primary Completion

August 17, 2022

Study Completion

December 2, 2022

Last Updated

March 29, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)