<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/NCT03839381</url>
  </required_header>
  <id_info>
    <org_study_id>ORDU345</org_study_id>
    <nct_id>NCT03839381</nct_id>
  </id_info>
  <brief_title>Turkish Version of Mini-BESTest, Validity and Reliability for Adult Participants With Sensoriomotor Impairments</brief_title>
  <official_title>Turkish Version of Mini-BESTest- Balance Evaluation Systems Test: A Translation and Transcultural Adaptation Study Incorporating Validity and Reliability Analysis for Adult Participants With Sensoriomotor Impairments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</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 present the Turkish version of miniBESTest which evaluates the&#xD;
      reasons of balance deficit and postural control. Accordingly, a practice of validity and&#xD;
      reliability on adult patients with sensoriomotor impairments will be performed by utilizing&#xD;
      the Turkish version of miniBESTest in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical therapists encounter postural control problems frequently. These problems require&#xD;
      multifaceted assessment. Therefore, the treatment of postural control problems should be&#xD;
      planned after a multifaceted assessment.&#xD;
&#xD;
      Balance Evaluation Systems Test (BESTest) comprises 27 items and evaluate all components of&#xD;
      postural control. MiniBESTest is a shortened version of BESTest with 14 tasks. MiniBESTest&#xD;
      still addresses almost all components of postural control and can be performed 15 min.&#xD;
      MiniBESTest is one of the most common methods which practiced on adult patients.&#xD;
&#xD;
      The aim of this study is to present the Turkish version of miniBESTest which evaluates the&#xD;
      reasons of balance deficit and postural control. Accordingly, a practice of validity and&#xD;
      reliability on adult participants with sensoriomotor impairments will be performed by&#xD;
      utilizing the Turkish version of miniBESTest in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 4, 2019</start_date>
  <completion_date type="Anticipated">December 4, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 29, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mini BESTest</measure>
    <time_frame>10-15 minutes.</time_frame>
    <description>Mini-BESTest focuses on dynamic balance. It includes a total of 14 different tasks, each rated on a 3-level between 0 (severe postural control impairment) and 2 (no postural control impairment) with a maximal score of 28.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Multiple Sclerosis</condition>
  <condition>Trauma, Brain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study was planned participants who have sensoriomotor impairments were referred to the&#xD;
        Ordu University Educational Research Hospital neurology clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of sensoriomotor impairment Able to walk with or without an assistive&#xD;
        device (e.g. walker, cane, ankle-foot orthosis...) Ability to tolerate the balance tasks&#xD;
        without fatigue.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Severe cognitive or communication impairments Hemodynamic or clinical instability.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sema Büğüşan Oruç, M.Sc.</last_name>
    <phone>+905059301510</phone>
    <email>semabugusan@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sevim Acaröz Candan, PhD</last_name>
    <phone>+905071027447</phone>
    <email>fzt_acaroz@hotmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.</citation>
    <PMID>20461334</PMID>
  </reference>
  <reference>
    <citation>Lemay JF, Roy A, Nadeau S, Gagnon DH. French version of the Mini BESTest: A translation and transcultural adaptation study incorporating a reliability analysis for individuals with sensorimotor impairments undergoing functional rehabilitation. Ann Phys Rehabil Med. 2019 May;62(3):149-154. doi: 10.1016/j.rehab.2018.12.001. Epub 2018 Dec 27.</citation>
    <PMID>30594663</PMID>
  </reference>
  <reference>
    <citation>Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.</citation>
    <PMID>19329772</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>Sema BÜĞÜŞAN ORUÇ</investigator_full_name>
    <investigator_title>PHD student</investigator_title>
  </responsible_party>
  <keyword>mini BESTest</keyword>
  <keyword>balance defisit</keyword>
  <keyword>postural control</keyword>
  <keyword>Sensoriomotor impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03839381
org study id: ORDU345
nct id: NCT03839381
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to present the Turkish version of miniBESTest which evaluates the
      reasons of balance deficit and postural control. Accordingly, a practice of validity and
      reliability on adult patients with sensoriomotor impairments will be performed by utilizing
      the Turkish version of miniBESTest in this study.
Physical therapists encounter postural control problems frequently. These problems require
      multifaceted assessment. Therefore, the treatment of postural control problems should be
      planned after a multifaceted assessment.

      Balance Evaluation Systems Test (BESTest) comprises 27 items and evaluate all components of
      postural control. MiniBESTest is a shortened version of BESTest with 14 tasks. MiniBESTest
      still addresses almost all components of postural control and can be performed 15 min.
      MiniBESTest is one of the most common methods which practiced on adult patients.

      The aim of this study is to present the Turkish version of miniBESTest which evaluates the
      reasons of balance deficit and postural control. Accordingly, a practice of validity and
      reliability on adult participants with sensoriomotor impairments will be performed by
      utilizing the Turkish version of miniBESTest in this study.
observational model: Case-Only
time perspective: Prospective
measure: Mini BESTest
time frame: 10-15 minutes.
description: Mini-BESTest focuses on dynamic balance. It includes a total of 14 different tasks, each rated on a 3-level between 0 (severe postural control impairment) and 2 (no postural control impairment) with a maximal score of 28.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sema Büğüşan Oruç, M.Sc.
phone: +905059301510
email: semabugusan@gmail.com
last name: Sevim Acaröz Candan, PhD
phone: +905071027447
email: fzt_acaroz@hotmail.com
citation: Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.
PMID: 20461334
citation: Lemay JF, Roy A, Nadeau S, Gagnon DH. French version of the Mini BESTest: A translation and transcultural adaptation study incorporating a reliability analysis for individuals with sensorimotor impairments undergoing functional rehabilitation. Ann Phys Rehabil Med. 2019 May;62(3):149-154. doi: 10.1016/j.rehab.2018.12.001. Epub 2018 Dec 27.
PMID: 30594663
citation: Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.
PMID: 19329772
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: Sema BÜĞÜŞAN ORUÇ
investigator title: PHD student
mesh term: Parkinson Disease
mesh term: Multiple Sclerosis
mesh term: Brain Injuries, Traumatic
sharing ipd: No