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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04820725
• Other study ID #: 05-06
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2021
• Est. completion date: December 2, 2022

Study information

• Verified date: January 2021
• Source: Gazi University
• Contact: Songul B Yentur
• Phone: 0424 237 8282
• Email: songulbaglan23[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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).

Locations

Country	Name	City	State
Turkey	Songul Baglan Yentur	Elazig

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait analyses	plantar pressure distribution	3 minutes
Secondary	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
Secondary	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
Secondary	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