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Cervical Stabilization Exercises in Patients With Spondyloarthritis

Primary Purpose

Spondyloarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring Arthritis, Exercise, Proprioception

Eligibility Criteria

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

Inclusion Criteria:

  • Being diagnosed as axial spondyloarthritis according to ASAS criteria
  • Being able to understand and follow the exercise commands
  • Willingness to participate in the study

Exclusion Criteria:

  • Trauma history related to cervical region
  • A completed ankylosis in cervical region
  • Surgery history related to cervical region
  • Any vestibular disorders
  • Upper extremity involvement other than axial spondyloarthritis

Sites / Locations

  • Izmir Katip Celebi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Group

Control Group

Arm Description

A progressive home-based cervical stabilization exercise program was delivered by sending messages and video instructions via a freeware and cross-platform messaging service (WhatsApp Messenger) in a weekly basis.

Patients in control group did not receive any exercise intervention.

Outcomes

Primary Outcome Measures

Change in Cervical Proprioception Accuracy
Cervical position error method was used to determine the cervical proprioception accuracy. Cervical position error was evaluated in flexion, extension, rotation and lateral flexion directions and was calculated using a special formula. The results were analyzed as angles.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2020
Last Updated
February 2, 2023
Sponsor
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT04483648
Brief Title
Cervical Stabilization Exercises in Patients With Spondyloarthritis
Official Title
Effect of Cervical Stabilization Exercises on Cervical Position Error in Patients With Spondyloarthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in spondyloarthritis patients.
Detailed Description
The position sense and kinesthesia are defined as proprioception. In other words, proprioception allows being aware of positions of the body parts in the space. Muscles, tendons, joint capsules are source of proprioception. Possible damage to these structures due to inflammation may cause diminished proprioception sense. Decreased proprioception was shown for cervical region in axial spondyloarthritis patients in a recent study. Different exercise programs may help increasing proprioception. Therefore, the aim of the present study is investigate the effects of cervical stabilization exercises on cervical proprioception accuracy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
Arthritis, Exercise, Proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
A progressive home-based cervical stabilization exercise program was delivered by sending messages and video instructions via a freeware and cross-platform messaging service (WhatsApp Messenger) in a weekly basis.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in control group did not receive any exercise intervention.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Home exercises were performed three times in a week for six weeks. Home exercises included range of motion exercises, coordination exercises and strengthening exercises. Repeats and durations of the exercises increased every week to provide progression.
Primary Outcome Measure Information:
Title
Change in Cervical Proprioception Accuracy
Description
Cervical position error method was used to determine the cervical proprioception accuracy. Cervical position error was evaluated in flexion, extension, rotation and lateral flexion directions and was calculated using a special formula. The results were analyzed as angles.
Time Frame
At baseline and six weeks later

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: Being diagnosed as axial spondyloarthritis according to ASAS criteria Being able to understand and follow the exercise commands Willingness to participate in the study Exclusion Criteria: Trauma history related to cervical region A completed ankylosis in cervical region Surgery history related to cervical region Any vestibular disorders Upper extremity involvement other than axial spondyloarthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Bayraktar, PT, PhD
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Katip Celebi University
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be sent upon a reasonable request.
IPD Sharing Time Frame
December 2022 to December 2042
IPD Sharing Access Criteria
Data will be sent for academical purposes (for conducting a meta-analysis or systematic review)
Citations:
PubMed Identifier
27188328
Citation
Sieper J, Braun J, Dougados M, Baeten D. Axial spondyloarthritis. Nat Rev Dis Primers. 2015 Jul 9;1:15013. doi: 10.1038/nrdp.2015.13.
Results Reference
background
PubMed Identifier
15167664
Citation
Swinkels A, Dolan P. Spinal position sense and disease progression in ankylosing spondylitis: a longitudinal study. Spine (Phila Pa 1976). 2004 Jun 1;29(11):1240-5. doi: 10.1097/00007632-200406010-00014.
Results Reference
background
PubMed Identifier
25703454
Citation
Roijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29.
Results Reference
background
PubMed Identifier
18201114
Citation
Armstrong B, McNair P, Taylor D. Head and neck position sense. Sports Med. 2008;38(2):101-17. doi: 10.2165/00007256-200838020-00002.
Results Reference
background
PubMed Identifier
18180194
Citation
Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control--Part 2: case studies. Man Ther. 2008 Jun;13(3):266-75. doi: 10.1016/j.math.2007.11.002. Epub 2008 Jan 3.
Results Reference
background
PubMed Identifier
28558952
Citation
Alahmari K, Reddy RS, Silvian P, Ahmad I, Nagaraj V, Mahtab M. Intra- and inter-rater reliability of neutral head position and target head position tests in patients with and without neck pain. Braz J Phys Ther. 2017 Jul-Aug;21(4):259-267. doi: 10.1016/j.bjpt.2017.05.003. Epub 2017 May 19.
Results Reference
background
PubMed Identifier
17143898
Citation
Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.
Results Reference
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Cervical Stabilization Exercises in Patients With Spondyloarthritis

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