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

Primary Purpose

Ankylosing Spondylitis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Plantar pressure and gait
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis,, posture, plantar pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Songul Baglan YenturRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Study group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gait analyses
plantar pressure distribution

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 25, 2021
Last Updated
March 25, 2021
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04820725
Brief Title
The Effects of Postural Changes on Plantar Pressure in Patients With Ankylosing Spondylitis
Official Title
The Effects of Postural Changes on Plantar Pressure in Patients With Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2021 (Anticipated)
Primary Completion Date
August 17, 2022 (Anticipated)
Study Completion Date
December 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis,, posture, plantar pressure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients whose BASMI score is 2 will be included in the study
Arm Title
Control group
Arm Type
Experimental
Arm Description
Patients whose BASMI score is 0 and 1 will be included in the study
Intervention Type
Diagnostic Test
Intervention Name(s)
Plantar pressure and gait
Intervention Description
Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated using Win-Track platform (MEDICAPTEURS Technology, France).
Primary Outcome Measure Information:
Title
Gait analyses
Description
plantar pressure distribution
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Bath Ankylosing Spondylitis Metrology Index
Description
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.
Time Frame
5 minutes
Title
Bath Ankylosing Spondylitis Disease Activity Index
Description
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.
Time Frame
1 minute
Title
Time up and go test
Description
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.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songul B Yentur
Phone
0424 237 8282
Email
songulbaglan23@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Süleyman S Koca
Organizational Affiliation
Firat University
Official's Role
Study Director
Facility Information:
Facility Name
Songul Baglan Yentur
City
Elazığ
ZIP/Postal Code
23000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songul B Yentur
Phone
+90 506 272 6511
Email
songulbaglan23@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29409278
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.
Results Reference
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PubMed Identifier
25684149
Citation
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.
Results Reference
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The Effects of Postural Changes on Plantar Pressure in Patients With Ankylosing Spondylitis

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