xml: <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/NCT05970939</url>
    </required_header>
    <id_info>
      <org_study_id>ND-Development-TrUQ</org_study_id>
      <nct_id>NCT05970939</nct_id>
    </id_info>
    <brief_title>Development, Reliability and Validity of the Telerehabilitation Usability Questionnaire- TrUQ</brief_title>
    <official_title>Development, Reliability and Validity of the Telerehabilitation Usability Questionnaire- TrUQ in Neurological Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gazi University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Neurological diseases are central nervous system diseases that cause an increase in the level&#xD;
        of disability and limitations in daily life. Multiple Sclerosis (MS), stroke, and Parkinson's&#xD;
        Disease (PD) are among the most common apparent neurological diseases, and epidemiological&#xD;
        studies show that their prevalence has increased over time worldwide. Although MS, stroke,&#xD;
        and PD have different causes and neurological aspects, they generally cause motor, sensory,&#xD;
        and/or cognitive impairments, leading to restriction of the individual's activities and&#xD;
        participation. Today, physiotherapy and rehabilitation approaches together with optimal&#xD;
        medical and surgical treatment are the cornerstones of treatment for these diseases.&#xD;
        Recently, it has been stated that various telerehabilitation interventions in the field of&#xD;
        physiotherapy and rehabilitation may be an additional option to the rehabilitation approaches&#xD;
        applied in the clinic. On the other hand, It is important to evaluate the level of usability&#xD;
        in expanding the usability of telerehabilitation services and determining the best&#xD;
        telerehabilitation service. For this reason, there is a need for questionnaires investigating&#xD;
        the satisfaction level of physiotherapy and rehabilitation applied through&#xD;
        telerehabilitation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Questionnaire items will be created in two stages. First, 5 experts will independently review&#xD;
        the literature on &quot;telerehabilitation&quot; and &quot;usability&quot;. In addition, these experts will be&#xD;
        asked to create a pool of questions based on their experiences in telerehabilitation and by&#xD;
        taking the opinions of patients receiving telerehabilitation about usability. Then, 5 experts&#xD;
        will come together and obtain a single question pool containing the questions they deem&#xD;
        important in their question pool. The second step will involve scaling the elements. In this&#xD;
        study, scale items will be scored on a five-point Likert scale, ranging from 1, strongly&#xD;
        disagree to 5, strongly agree. Then, it will be applied to a pilot group of 10 people and it&#xD;
        will be evaluated whether the items prepared by the experts are understood by the patients.&#xD;
        In line with the expert opinion and the result of the pilot study, the final version of the&#xD;
        scale will be decided and applied to MS, PD, and stroke patients who make up the study group.&#xD;
        Finally, the validity and reliability of the questionnaire will be calculated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 28, 2023</start_date>
    <completion_date type="Anticipated">August 28, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 28, 2023</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>Telerehabilitation Usability Questionnaire in patients with Neurological disease</measure>
      <time_frame>Baseline</time_frame>
      <description>Patients get a minimum of 0 points (best condition) and a maximum of 4 points (worst condition) for each question on this scale</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Telerehabilitation Usability Questionnaire in patients with Neurological disease-Second</measure>
      <time_frame>he second assessment will be conducted after the one week</time_frame>
      <description>Patients get a minimum of 0 points (best condition) and a maximum of 4 points (worst condition) for each question on this scale</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Neurological Disease</condition>
    <arm_group>
      <arm_group_label>Telerehabilitation Usability</arm_group_label>
      <description>Telerehabilitation Usability Group</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Development of the Telerehabilitation Usability Questionnaire</intervention_name>
      <description>This study will be examined the development, validity, and reliability of the Telerehabilitation Usability Questionnaire in patients with MS.</description>
      <arm_group_label>Telerehabilitation Usability</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Neurological patients receiving physiotherapy and rehabilitation via telerehabilitation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Voluntarily participate in research to accept&#xD;
  &#xD;
            -  Mini-Mental Test score more than or equal 24&#xD;
  &#xD;
            -  Previously receiving physical therapy through telerehabilitation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any visual, hearing, and perception problems that may affect the answering the&#xD;
               questionnaire items&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kader Eldemir</last_name>
      <phone>+9 0452 226 52 48</phone>
      <email>fztkader2015@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gazi University</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4985278/</url>
      <description>Reference 1</description>
    </link>
    <reference>
      <citation>Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.</citation>
      <PMID>27563386</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
      <investigator_full_name>Kader Eldemir</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>Multiple Sclerosis</keyword>
    <keyword>Parkinson Disease</keyword>
    <keyword>Stroke</keyword>
    <keyword>Usability</keyword>
    <keyword>Telerehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nervous System Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970939
  org study id: ND-Development-TrUQ
  nct id: NCT05970939
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Neurological diseases are central nervous system diseases that cause an increase in the level
        of disability and limitations in daily life. Multiple Sclerosis (MS), stroke, and Parkinson's
        Disease (PD) are among the most common apparent neurological diseases, and epidemiological
        studies show that their prevalence has increased over time worldwide. Although MS, stroke,
        and PD have different causes and neurological aspects, they generally cause motor, sensory,
        and/or cognitive impairments, leading to restriction of the individual's activities and
        participation. Today, physiotherapy and rehabilitation approaches together with optimal
        medical and surgical treatment are the cornerstones of treatment for these diseases.
        Recently, it has been stated that various telerehabilitation interventions in the field of
        physiotherapy and rehabilitation may be an additional option to the rehabilitation approaches
        applied in the clinic. On the other hand, It is important to evaluate the level of usability
        in expanding the usability of telerehabilitation services and determining the best
        telerehabilitation service. For this reason, there is a need for questionnaires investigating
        the satisfaction level of physiotherapy and rehabilitation applied through
        telerehabilitation.
  Questionnaire items will be created in two stages. First, 5 experts will independently review
        the literature on "telerehabilitation" and "usability". In addition, these experts will be
        asked to create a pool of questions based on their experiences in telerehabilitation and by
        taking the opinions of patients receiving telerehabilitation about usability. Then, 5 experts
        will come together and obtain a single question pool containing the questions they deem
        important in their question pool. The second step will involve scaling the elements. In this
        study, scale items will be scored on a five-point Likert scale, ranging from 1, strongly
        disagree to 5, strongly agree. Then, it will be applied to a pilot group of 10 people and it
        will be evaluated whether the items prepared by the experts are understood by the patients.
        In line with the expert opinion and the result of the pilot study, the final version of the
        scale will be decided and applied to MS, PD, and stroke patients who make up the study group.
        Finally, the validity and reliability of the questionnaire will be calculated.
  observational model: Case-Only
  time perspective: Prospective
  measure: Telerehabilitation Usability Questionnaire in patients with Neurological disease
  time frame: Baseline
  description: Patients get a minimum of 0 points (best condition) and a maximum of 4 points (worst condition) for each question on this scale
  measure: Telerehabilitation Usability Questionnaire in patients with Neurological disease-Second
  time frame: he second assessment will be conducted after the one week
  description: Patients get a minimum of 0 points (best condition) and a maximum of 4 points (worst condition) for each question on this scale
  arm group label: Telerehabilitation Usability
  description: Telerehabilitation Usability Group
  intervention type: Other
  intervention name: Development of the Telerehabilitation Usability Questionnaire
  description: This study will be examined the development, validity, and reliability of the Telerehabilitation Usability Questionnaire in patients with MS.
  arm group label: Telerehabilitation Usability
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kader Eldemir
  phone: +9 0452 226 52 48
  email: fztkader2015@gmail.com
  facility: 
  country: Turkey
  url: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4985278/
  description: Reference 1
  citation: Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
  PMID: 27563386
  responsible party type: Principal Investigator
  investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
  investigator full name: Kader Eldemir
  investigator title: principal investigator
  mesh term: Nervous System Diseases
  sharing ipd: No