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/NCT06011174</url>
    </required_header>
    <id_info>
      <org_study_id>Gurbuz03</org_study_id>
      <nct_id>NCT06011174</nct_id>
    </id_info>
    <brief_title>Validity and Reliability of the Turkish Version of the Post-Stroke Physical Activity Barriers Scale in Patients With Stroke</brief_title>
    <official_title>Validity and Reliability of the Turkish Version of the Post-Stroke Physical Activity Barriers Scale in Patients With Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kırıkkale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kırıkkale 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>
        Stroke is one of the leading causes that negatively affects quality of life. The benefits of&#xD;
        regular physical activity are well recognized. Physical activity after stroke may prevent&#xD;
        disability and recurrence of stroke. Physical impairments seen after stroke may prevent&#xD;
        exercise and limit subsequent recovery. According to a 2016 systematic review updated and&#xD;
        published in the Cochrane Library, physical activity programs have positive effects on&#xD;
        disability, physical abilities, quality of life, mood and cardiovascular. However, these&#xD;
        effects tend to diminish unless the individual's physical activity level is maintained.&#xD;
        Therefore, individuals who have had a stroke should be encouraged to exercise. However, it&#xD;
        has been reported that most of the patients do not participate in exercise programs as&#xD;
        recommended after stroke and there is a decrease in physical activity level. Previous studies&#xD;
        have reported that approximately 77% of patients with stroke are sedentary or have low levels&#xD;
        of physical activity and also reduced frequency of physical activity. This may be a&#xD;
        consequence of the reduced movement speed seen due to severe motor impairments.&#xD;
        Interestingly, even those with mild motor impairments, i.e. those walking at speeds above 0.8&#xD;
        m/s and able to participate in community-based exercises, were found to have low levels of&#xD;
        physical activity. Therefore, environmental and personal factors can also be barriers to&#xD;
        exercise.&#xD;
  &#xD;
        Research supports the use of the theoretical model of behavior change developed by Prochaska&#xD;
        et al. in physical activity promotion. Individuals are thought to progress through the stages&#xD;
        of change at different rates. The concepts of self-efficacy and decision balance (perceived&#xD;
        benefits and barriers) are particularly salient for individuals in the pre-thinking and&#xD;
        thinking stages. Therefore, identifying and understanding perceived barriers to engaging in&#xD;
        physical activity is an important step in creating change in physical activity behaviors. The&#xD;
        International Classification of Functioning, Disability and Health defines functioning and&#xD;
        disability as multidimensional concepts in which activity, especially physical activity, is&#xD;
        influenced by organic and contextual factors. These dimensions often change after stroke and&#xD;
        create multiple barriers that may prevent the patient from returning to a physically active&#xD;
        lifestyle. Previous studies on barriers to physical activity in stroke survivors have used&#xD;
        open-ended questionnaires. When we look at the scales examining exercise and physical&#xD;
        activity barriers in the literature, it is seen that they were developed to measure physical&#xD;
        activity barriers in the general population and in individuals with chronic conditions.&#xD;
        Therefore, the Barriers to Physical Activity After Stroke (BAPAS) scale was developed by&#xD;
        Drigny et al. in 2019 to help physicians and therapists identify potential targets for future&#xD;
        interventions and optimize clinical follow-up in stroke patients and to assess barriers to&#xD;
        physical activity after stroke. The original scale is in French and there is also an English&#xD;
        version. Since the scale was recently developed, there is no Turkish version and no version&#xD;
        in other languages.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">February 5, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 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>the Barriers to Physical Activity After Stroke (BAPAS) SCALE</measure>
      <time_frame>10 minute</time_frame>
      <description>The necessary permissions were obtained from the authors of the BAPAS, whose validity and reliability features were to be tested, and the questionnaire was finalized by completing the translation process into Turkish. What is essential in the use of special tools such as scales is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation from the original language to the other language. At this stage, it is ideal to have a good knowledge of the structure of the target language and the original language.&#xD;
  is to have competent and experienced people do the translation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Barthel Activities of Daily Living Index (BADLI)</measure>
      <time_frame>5 minute</time_frame>
      <description>SURVEY</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Rivermead motor assessment (RMA)</measure>
      <time_frame>2 minute</time_frame>
      <description>SURVEY</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Stroke</condition>
    <condition>Physical Inactivity</condition>
    <arm_group>
      <arm_group_label>post-stroke patient</arm_group_label>
      <description>Being 18 years of age or older,&#xD;
  being diagnosed with hemorrhagic or ischemic stroke,&#xD;
  No cooperation and communication problems&#xD;
  Being able to walk independently</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>survey application</intervention_name>
      <description>Participants will only be asked to fill out the questionnaires.</description>
      <arm_group_label>post-stroke patient</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A standard probability in their use of validity and reliability is unlikely. Generally, it&#xD;
          states that at least 3 or 5-10 people should be recruited for each lime substance in lime&#xD;
          studies (1,2). For this reason, since the Turkish version of the Post-Stroke Physical&#xD;
          Activity Barriers Scale, which consists of 14 items, contains the validity and reliability,&#xD;
          it is planned to enroll 70 people with stroke, whose item approach is 5 times higher.&#xD;
          Patients coming to Kırıkkale University Faculty of Medicine Physical Therapy and&#xD;
          Rehabilitation Hospital will be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Being 18 years of age or older, 2. being diagnosed with hemorrhagic or ischemic&#xD;
               stroke, 3. No cooperation and communication problems 4. Being able to walk&#xD;
               independently&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Having another neurological or orthopedic problem other than stroke that may affect&#xD;
               functionality, ambulation and balance 2. Individuals with advanced cardiovascular&#xD;
               disease that may prevent physical activity and contraindications for mobilization will&#xD;
               not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alper K Gürbüz, master</last_name>
      <phone>+905364014402</phone>
      <email>alperkemal4@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kırıkkale University</name>
        <address>
          <city>Kirikkale</city>
          <zip>71450</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alper K Gürbüz</last_name>
        <email>alperkemal4@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kırıkkale University</investigator_affiliation>
      <investigator_full_name>Alper Kemal Gürbüz</investigator_full_name>
      <investigator_title>research asistant</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</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/NCT06011174
  org study id: Gurbuz03
  nct id: NCT06011174
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Stroke is one of the leading causes that negatively affects quality of life. The benefits of
        regular physical activity are well recognized. Physical activity after stroke may prevent
        disability and recurrence of stroke. Physical impairments seen after stroke may prevent
        exercise and limit subsequent recovery. According to a 2016 systematic review updated and
        published in the Cochrane Library, physical activity programs have positive effects on
        disability, physical abilities, quality of life, mood and cardiovascular. However, these
        effects tend to diminish unless the individual's physical activity level is maintained.
        Therefore, individuals who have had a stroke should be encouraged to exercise. However, it
        has been reported that most of the patients do not participate in exercise programs as
        recommended after stroke and there is a decrease in physical activity level. Previous studies
        have reported that approximately 77% of patients with stroke are sedentary or have low levels
        of physical activity and also reduced frequency of physical activity. This may be a
        consequence of the reduced movement speed seen due to severe motor impairments.
        Interestingly, even those with mild motor impairments, i.e. those walking at speeds above 0.8
        m/s and able to participate in community-based exercises, were found to have low levels of
        physical activity. Therefore, environmental and personal factors can also be barriers to
        exercise.
  
        Research supports the use of the theoretical model of behavior change developed by Prochaska
        et al. in physical activity promotion. Individuals are thought to progress through the stages
        of change at different rates. The concepts of self-efficacy and decision balance (perceived
        benefits and barriers) are particularly salient for individuals in the pre-thinking and
        thinking stages. Therefore, identifying and understanding perceived barriers to engaging in
        physical activity is an important step in creating change in physical activity behaviors. The
        International Classification of Functioning, Disability and Health defines functioning and
        disability as multidimensional concepts in which activity, especially physical activity, is
        influenced by organic and contextual factors. These dimensions often change after stroke and
        create multiple barriers that may prevent the patient from returning to a physically active
        lifestyle. Previous studies on barriers to physical activity in stroke survivors have used
        open-ended questionnaires. When we look at the scales examining exercise and physical
        activity barriers in the literature, it is seen that they were developed to measure physical
        activity barriers in the general population and in individuals with chronic conditions.
        Therefore, the Barriers to Physical Activity After Stroke (BAPAS) scale was developed by
        Drigny et al. in 2019 to help physicians and therapists identify potential targets for future
        interventions and optimize clinical follow-up in stroke patients and to assess barriers to
        physical activity after stroke. The original scale is in French and there is also an English
        version. Since the scale was recently developed, there is no Turkish version and no version
        in other languages.
  observational model: Case-Only
  time perspective: Prospective
  measure: the Barriers to Physical Activity After Stroke (BAPAS) SCALE
  time frame: 10 minute
  description: The necessary permissions were obtained from the authors of the BAPAS, whose validity and reliability features were to be tested, and the questionnaire was finalized by completing the translation process into Turkish. What is essential in the use of special tools such as scales is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation from the original language to the other language. At this stage, it is ideal to have a good knowledge of the structure of the target language and the original language.
  is to have competent and experienced people do the translation
  measure: The Barthel Activities of Daily Living Index (BADLI)
  time frame: 5 minute
  description: SURVEY
  measure: The Rivermead motor assessment (RMA)
  time frame: 2 minute
  description: SURVEY
  arm group label: post-stroke patient
  description: Being 18 years of age or older,
  being diagnosed with hemorrhagic or ischemic stroke,
  No cooperation and communication problems
  Being able to walk independently
  intervention type: Other
  intervention name: survey application
  description: Participants will only be asked to fill out the questionnaires.
  arm group label: post-stroke patient
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Alper K Gürbüz, master
  phone: +905364014402
  email: alperkemal4@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kırıkkale University
  investigator full name: Alper Kemal Gürbüz
  investigator title: research asistant
  mesh term: Stroke
  sharing ipd: Yes