<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/NCT04425928</url>
  </required_header>
  <id_info>
    <org_study_id>5057087198</org_study_id>
    <nct_id>NCT04425928</nct_id>
  </id_info>
  <brief_title>Activity Treatment on Vestibular Rehabilitation</brief_title>
  <official_title>Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bilgehan Tekin Dal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study it was aimed to investigate the effects of home treatment program based&#xD;
      standard activity on dizziness, balance and daily life activity in patients with dizziness&#xD;
      complaint originated from chronic unilateral peripheral vestibular disorder and compare to&#xD;
      effects of exercise-based home rehabilitation program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to assess the effects of an activity training programme on&#xD;
      dizziness, imbalance, and level of independence in daily living activities in patients with&#xD;
      chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral&#xD;
      vestibular disorders and individuals with vestibular rehabilitation indications were included&#xD;
      in our study. Patients were randomly divided into 3 groups consist of 25 patients as an&#xD;
      activity group, exercise group, and control group. Education was given to each group. İn&#xD;
      addition, the activity group was performed a training activities program, the exercise group&#xD;
      was performed in the Cawthorne-Cooksey exercises program. Therapy programs were prescribed&#xD;
      once daily at home for 4 weeks. After demographic information was obtained from all patients,&#xD;
      assessments were performed at the beginning and at the end of the treatment program (4&#xD;
      weeks). Dizziness severity was assessed by the Visual Analog Scale (VAS), activities of daily&#xD;
      livings were assessed by Vestibular Disorders Activity Questionnaire (VADL) and balance was&#xD;
      assessed by Sensory Organization Testing (SOT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2018</start_date>
  <completion_date type="Actual">November 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS).</measure>
    <time_frame>before and after treatment (4 weeks)</time_frame>
    <description>VAS is a self-reported instrument assessing the severity of diziness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from before and after treatment in the Independent level of activity in the daily life on Vestibular Disorders Activities of Daily Living Scale (VADL).</measure>
    <time_frame>before and after treatment (4 weeks)</time_frame>
    <description>VADL is a questionnaire assessing the Independent level of activity in daily life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from before and after treatment in the postural stability on Computerized Dynamic Posturography (CDP).</measure>
    <time_frame>before and after treatment (4 weeks)</time_frame>
    <description>Computerized dynamic posturography (CDP) testing is a technique used to assess underlying sensory and motor control impairments associated with balance disorders.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Vestibular Disorder</condition>
  <arm_group>
    <arm_group_label>activity group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received an activity-based home program that was performed for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received an exercise-based home program was performed that was performed for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>occupational therapy based activity training programs</intervention_name>
    <description>Occupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation.</description>
    <arm_group_label>activity group</arm_group_label>
    <other_name>purposeful activities</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physiotherapy based exercise training programs</intervention_name>
    <description>Cawthorne-cooksey exercises were performed at vestibular rehabilitation</description>
    <arm_group_label>exercise group</arm_group_label>
    <other_name>Cawthorne-cooksey exercises</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients have dizziness complaint longer than 3 months,&#xD;
&#xD;
          -  History of at least one dizziness in a month&#xD;
&#xD;
          -  Patient has been diagnosed chronic unilateral peripheric vestibular disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosed benign paroxysmal positional vertigo, had Meniere's disease,&#xD;
             had history of central nerve system impairments and/or psychiatric disorder, had&#xD;
             uncontrolled hypertension and diabetes, had not understanding simple verbal&#xD;
             instruction and following ability, not able to stand independent in the standstill&#xD;
             position, had visual problems that cannot be treated with lenses or glasses, had&#xD;
             movement limitation due to the orthopedic problem, using medication for dizziness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gonca Bumin, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Bilgehan Tekin Dal</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vestibular 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>


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/NCT04425928
org study id: 5057087198
nct id: NCT04425928
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
In this study it was aimed to investigate the effects of home treatment program based
      standard activity on dizziness, balance and daily life activity in patients with dizziness
      complaint originated from chronic unilateral peripheral vestibular disorder and compare to
      effects of exercise-based home rehabilitation program.
The aim of this study was to assess the effects of an activity training programme on
      dizziness, imbalance, and level of independence in daily living activities in patients with
      chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral
      vestibular disorders and individuals with vestibular rehabilitation indications were included
      in our study. Patients were randomly divided into 3 groups consist of 25 patients as an
      activity group, exercise group, and control group. Education was given to each group. İn
      addition, the activity group was performed a training activities program, the exercise group
      was performed in the Cawthorne-Cooksey exercises program. Therapy programs were prescribed
      once daily at home for 4 weeks. After demographic information was obtained from all patients,
      assessments were performed at the beginning and at the end of the treatment program (4
      weeks). Dizziness severity was assessed by the Visual Analog Scale (VAS), activities of daily
      livings were assessed by Vestibular Disorders Activity Questionnaire (VADL) and balance was
      assessed by Sensory Organization Testing (SOT).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS).
time frame: before and after treatment (4 weeks)
description: VAS is a self-reported instrument assessing the severity of diziness.
measure: Change from before and after treatment in the Independent level of activity in the daily life on Vestibular Disorders Activities of Daily Living Scale (VADL).
time frame: before and after treatment (4 weeks)
description: VADL is a questionnaire assessing the Independent level of activity in daily life.
measure: Change from before and after treatment in the postural stability on Computerized Dynamic Posturography (CDP).
time frame: before and after treatment (4 weeks)
description: Computerized dynamic posturography (CDP) testing is a technique used to assess underlying sensory and motor control impairments associated with balance disorders.
arm group label: activity group
arm group type: Active Comparator
description: Participants received an activity-based home program that was performed for 4 weeks.
arm group label: exercise group
arm group type: Experimental
description: Participants received an exercise-based home program was performed that was performed for 4 weeks.
arm group label: control group
arm group type: No Intervention
description: No intervention
intervention type: Procedure
intervention name: occupational therapy based activity training programs
description: Occupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation.
arm group label: activity group
other name: purposeful activities
intervention type: Procedure
intervention name: Physiotherapy based exercise training programs
description: Cawthorne-cooksey exercises were performed at vestibular rehabilitation
arm group label: exercise group
other name: Cawthorne-cooksey exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Gonca Bumin, Prof
role: Study Director
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Gazi University
investigator full name: Bilgehan Tekin Dal
investigator title: Research Assistant
mesh term: Vestibular Diseases
sharing ipd: No