The Effects of Postural Changes on Plantar Pressure in Patients With Ankylosing Spondylitis

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.

Study Overview

• Status: Unknown
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Diagnostic test: Plantar pressure and gait

Detailed Description

Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Reduction in flexibility and mobility is important factors that can cause impairment quality of life, reduction of exercise tolerance and pulmonary capacity with the progression of AS. Extra articular symptoms such as neurologic, cardiovascular and pulmonary involvement affect morbidity and mortality rate. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. Şahlı et al. concluded that 52% of AS patients had foot involvement but 35% of the patients had symptoms. To be determined plantar pressure distribution is important to be decided body weight distribution, postural control and selection of shoes. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Songul B Yentur; Phone Number: 0424 237 8282; Email: songulbaglan23@hotmail.com

Study Locations

• Turkey
  • Elazığ, Turkey, 23000
    • Recruiting
    • Songül Bağlan Yentür
    • Contact: Songul B Yentur; Phone Number: +90 506 272 6511; Email: songulbaglan23@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Patients whose BASMI score is 2 will be included in the study	Diagnostic test: Plantar pressure and gait; Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated using Win-Track platform (MEDICAPTEURS Technology, France).
Experimental: Control group; Patients whose BASMI score is 0 and 1 will be included in the study	Diagnostic test: Plantar pressure and gait; Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated using Win-Track platform (MEDICAPTEURS Technology, France).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait analyses	plantar pressure distribution	3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes
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.	1 minute
Time up and go test	The patient starts in a seated position. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated.	1 minute

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: Süleyman S Koca, Firat University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2021
• Primary Completion (Anticipated): August 17, 2022
• Study Completion (Anticipated): December 2, 2022

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: posture; plantar pressure; Ankylosing Spondylitis,
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: 05-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No