<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04483648</url>
  </required_header>
  <id_info>
    <org_study_id>SpAJPE</org_study_id>
    <nct_id>NCT04483648</nct_id>
  </id_info>
  <brief_title>Cervical Stabilization Exercises in Patients With Spondyloarthritis</brief_title>
  <official_title>Effect of Cervical Stabilization Exercises on Cervical Position Error in Patients With Spondyloarthritis: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Izmir Katip Celebi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Izmir Katip Celebi University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the effectiveness of cervical stabilization exercises&#xD;
      on cervical positioning error in spondyloarthritis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The position sense and kinesthesia are defined as proprioception. In other words,&#xD;
      proprioception allows being aware of positions of the body parts in the space. Muscles,&#xD;
      tendons, joint capsules are source of proprioception.&#xD;
&#xD;
      Possible damage to these structures due to inflammation may cause diminished proprioception&#xD;
      sense. Decreased proprioception was shown for cervical region in axial spondyloarthritis&#xD;
      patients in a recent study.&#xD;
&#xD;
      Different exercise programs may help increasing proprioception. Therefore, the aim of the&#xD;
      present study is investigate the effects of cervical stabilization exercises on cervical&#xD;
      proprioception accuracy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cervical Proprioception Accuracy</measure>
    <time_frame>At baseline and six weeks later</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Spondyloarthritis</condition>
  <arm_group>
    <arm_group_label>Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in control group did not receive any exercise intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <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.</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being diagnosed as axial spondyloarthritis according to ASAS criteria&#xD;
&#xD;
          -  Being able to understand and follow the exercise commands&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Trauma history related to cervical region&#xD;
&#xD;
          -  A completed ankylosis in cervical region&#xD;
&#xD;
          -  Surgery history related to cervical region&#xD;
&#xD;
          -  Any vestibular disorders&#xD;
&#xD;
          -  Upper extremity involvement other than axial spondyloarthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deniz Bayraktar, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Izmir Katip Celebi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Izmir Katip Celebi University</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>27188328</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>15167664</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25703454</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18201114</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18180194</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28558952</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17143898</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Izmir Katip Celebi University</investigator_affiliation>
    <investigator_full_name>Deniz Bayraktar</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Arthritis</keyword>
  <keyword>Exercise</keyword>
  <keyword>Proprioception</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be sent upon a reasonable request.</ipd_description>
    <ipd_time_frame>December 2022 to December 2042</ipd_time_frame>
    <ipd_access_criteria>Data will be sent for academical purposes (for conducting a meta-analysis or systematic review)</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04483648
org study id: SpAJPE
nct id: NCT04483648
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the effectiveness of cervical stabilization exercises
      on cervical positioning error in spondyloarthritis patients.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Cervical Proprioception Accuracy
time frame: At baseline and six weeks later
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.
arm group label: Exercise Group
arm group type: Experimental
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 group label: Control Group
arm group type: No Intervention
description: Patients in control group did not receive any exercise intervention.
intervention type: Other
intervention name: Exercise
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.
arm group label: Exercise Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Deniz Bayraktar, PT, PhD
role: Principal Investigator
affiliation: Izmir Katip Celebi University
facility: 
country: Turkey
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.
PMID: 27188328
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.
PMID: 15167664
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.
PMID: 25703454
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.
PMID: 18201114
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.
PMID: 18180194
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.
PMID: 28558952
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.
PMID: 17143898
responsible party type: Principal Investigator
investigator affiliation: Izmir Katip Celebi University
investigator full name: Deniz Bayraktar
investigator title: Assistant Professor
mesh term: Spondylitis
mesh term: Spondylarthritis
sharing ipd: Yes
ipd description: Data will be sent upon a reasonable request.
ipd time frame: December 2022 to December 2042
ipd access criteria: Data will be sent for academical purposes (for conducting a meta-analysis or systematic review)