<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/NCT03230513</url>
  </required_header>
  <id_info>
    <org_study_id>MREC ID NO: 20155-1337</org_study_id>
    <nct_id>NCT03230513</nct_id>
  </id_info>
  <brief_title>Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms</brief_title>
  <official_title>Comparison of Home-Based Modified Self-Epley Manoeuvre and Brandt-Daroff Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms: A Randomized Single-Blind Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</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>
      Benign paroxysmal positional vertigo (BPPV) is the most common vestibular disorder in adults&#xD;
      and the treatment of choice is by particle repositioning manoeuvres (PRM). This study aims to&#xD;
      compare the treatment efficacy of two home-based exercises, self-Epley manoeuvre (SEM) and&#xD;
      Brandt-Daroff exercise (BDE) in patients with posterior canal BPPV based on vertigo&#xD;
      resolution, reduction of vertigo intensity, the Dizziness Handicap Inventory scores and the&#xD;
      conversion of a positive to negative Dix-Hallpike test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Objective:&#xD;
&#xD;
      To compare the efficacy of the self-Epley manoeuvre to the Brandt-Daroff exercise in&#xD;
      resolving vertigo symptoms in patients with unilateral posterior canal BPPV.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      Single-blind randomized controlled study&#xD;
&#xD;
      Sample Size:&#xD;
&#xD;
      Fifty patients were recruited in the study and were divided with 25 patients in each&#xD;
      treatment arm.&#xD;
&#xD;
      Study Method:&#xD;
&#xD;
      Patients who satisfy the inclusion criteria and have given informed consent were randomized&#xD;
      into the 2 treatment groups. A dedicated physiotherapist will demonstrate the selected&#xD;
      exercise (either SEM or BDE) and observed the patient performing the exercise twice to ensure&#xD;
      the ability of the patient to perform it correctly at home. A diary was provided for the&#xD;
      patients to chart the therapy sessions performed at home as well as a pamphlet with simple&#xD;
      illustrated instructions of the chosen exercise. The patients were asked to perform the&#xD;
      home-based exercise for 2 weeks.&#xD;
&#xD;
      Primary Outcome Measure&#xD;
&#xD;
      - Resolution of vertigo symptoms in patients with unilateral posterior canal BPPV.&#xD;
&#xD;
      Secondary Outcome Measures&#xD;
&#xD;
        -  Vertigo resolution at 1 and 6 months;&#xD;
&#xD;
        -  The conversion of positive to negative Dix-Hallpike test between both groups after 1&#xD;
           month;&#xD;
&#xD;
        -  Vertigo intensity in unresolved vertigo patients at 1 &amp; 6 months;&#xD;
&#xD;
        -  The Dizziness Handicap Inventory between both groups at 1 and 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>
    <intervention_model_description>Participants were assigned to either the SEM group (written as &quot;Group A&quot;) or the BDE group (written as &quot;Group B&quot;) throughout the duration of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The Primary Investigator (PI) was blinded as to the exercise type that the patient had learned and used and evaluates all the outcomes of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Vertigo resolution</measure>
    <time_frame>Assessed at 1 month and 6 months following initiation of home-based exercise.</time_frame>
    <description>Present or absent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conversion of a positive to negative Dix-Hallpike test</measure>
    <time_frame>Assessed at 1 month following initiation of home-based exercise.</time_frame>
    <description>Positive or negative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vertigo intensity</measure>
    <time_frame>Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.</time_frame>
    <description>Patients were asked to rate the average severity or intensity of the vertigo episode in the previous one week based on a 1-to-5 Likert scale, with a scale of 5 implying the most intense or severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness Handicap Inventory</measure>
    <time_frame>Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.</time_frame>
    <description>A 25 item questionnaire that encompasses 3 domains which are functional, physical and emotional. The scores are summed with maximum score of 100 and the higher the score, the greater the perceived handicap.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Benign Paroxysmal Positional Vertigo</condition>
  <arm_group>
    <arm_group_label>Self Epley Manoeuvre</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Self Epley Manoeuvre.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brandt-Daroff Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brandt-Daroff Exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self Epley Manoeuvre</intervention_name>
    <description>The patient has to position himself long sitting on the bed, then turn his head 45 degrees to the problematic side. When in this head position, he will rapidly lie himself supine with a pillow under his shoulders. He then turns his head 90 degrees to the opposite direction followed by turning of his body to the same side before returning to a sitting position at the edge of the bed. Each position should be kept for 30 seconds each, and the patient is required to perform 3 cycles of this manoeuvre just prior to going to bed daily for 2 weeks.</description>
    <arm_group_label>Self Epley Manoeuvre</arm_group_label>
    <other_name>SEM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brandt-Daroff Exercise</intervention_name>
    <description>The patient has to sit at the edge of the bed, turn his head laterally 45 degrees to one side and move rapidly into the side lying position, keeping his head in the same position. He then returns upright and turns his head to the opposite direction and the same movement is repeated on the other side. Each position is held for at least 30 seconds and the patient is required to perform it for 5 repetitions, three times a day, daily for 2 weeks duration.</description>
    <arm_group_label>Brandt-Daroff Exercise</arm_group_label>
    <other_name>BDE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who have had symptoms of vertigo for at least 1 week duration,&#xD;
&#xD;
          -  patients with a documented positive Dix-Hallpike test on referral,&#xD;
&#xD;
          -  patients with intact cognitive function and had the ability to communicate and&#xD;
             understand instructions to perform a home-based exercise.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with history of prior ear surgery,&#xD;
&#xD;
          -  patients with orthopaedic or connective tissue disorder that impairs functional neck&#xD;
             or trunk range of motion,&#xD;
&#xD;
          -  patients with a significant neurological disorder or spinal cord damage, and&#xD;
&#xD;
          -  patients who have been prescribed with home-based exercises for BPPV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mazlina Mazlan, MBBS, MRM</last_name>
    <role>Study Chair</role>
    <affiliation>University Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nor Hanim Mohamad Hanapi, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Malaya</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vertigo</keyword>
  <keyword>benign paroxysmal positional vertigo</keyword>
  <keyword>particle repositioning manoeuvre</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Benign Paroxysmal Positional Vertigo</mesh_term>
    <mesh_term>Dizziness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03230513
org study id: MREC ID NO: 20155-1337
nct id: NCT03230513
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Benign paroxysmal positional vertigo (BPPV) is the most common vestibular disorder in adults
      and the treatment of choice is by particle repositioning manoeuvres (PRM). This study aims to
      compare the treatment efficacy of two home-based exercises, self-Epley manoeuvre (SEM) and
      Brandt-Daroff exercise (BDE) in patients with posterior canal BPPV based on vertigo
      resolution, reduction of vertigo intensity, the Dizziness Handicap Inventory scores and the
      conversion of a positive to negative Dix-Hallpike test.
Study Objective:

      To compare the efficacy of the self-Epley manoeuvre to the Brandt-Daroff exercise in
      resolving vertigo symptoms in patients with unilateral posterior canal BPPV.

      Study Design:

      Single-blind randomized controlled study

      Sample Size:

      Fifty patients were recruited in the study and were divided with 25 patients in each
      treatment arm.

      Study Method:

      Patients who satisfy the inclusion criteria and have given informed consent were randomized
      into the 2 treatment groups. A dedicated physiotherapist will demonstrate the selected
      exercise (either SEM or BDE) and observed the patient performing the exercise twice to ensure
      the ability of the patient to perform it correctly at home. A diary was provided for the
      patients to chart the therapy sessions performed at home as well as a pamphlet with simple
      illustrated instructions of the chosen exercise. The patients were asked to perform the
      home-based exercise for 2 weeks.

      Primary Outcome Measure

      - Resolution of vertigo symptoms in patients with unilateral posterior canal BPPV.

      Secondary Outcome Measures

        -  Vertigo resolution at 1 and 6 months;

        -  The conversion of positive to negative Dix-Hallpike test between both groups after 1
           month;

        -  Vertigo intensity in unresolved vertigo patients at 1 & 6 months;

        -  The Dizziness Handicap Inventory between both groups at 1 and 6 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were assigned to either the SEM group (written as "Group A") or the BDE group (written as "Group B") throughout the duration of the study.
primary purpose: Treatment
masking: Single (Investigator)
masking description: The Primary Investigator (PI) was blinded as to the exercise type that the patient had learned and used and evaluates all the outcomes of the study.
measure: Vertigo resolution
time frame: Assessed at 1 month and 6 months following initiation of home-based exercise.
description: Present or absent
measure: Conversion of a positive to negative Dix-Hallpike test
time frame: Assessed at 1 month following initiation of home-based exercise.
description: Positive or negative
measure: Vertigo intensity
time frame: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
description: Patients were asked to rate the average severity or intensity of the vertigo episode in the previous one week based on a 1-to-5 Likert scale, with a scale of 5 implying the most intense or severe.
measure: Dizziness Handicap Inventory
time frame: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
description: A 25 item questionnaire that encompasses 3 domains which are functional, physical and emotional. The scores are summed with maximum score of 100 and the higher the score, the greater the perceived handicap.
arm group label: Self Epley Manoeuvre
arm group type: Active Comparator
description: Self Epley Manoeuvre.
arm group label: Brandt-Daroff Exercise
arm group type: Active Comparator
description: Brandt-Daroff Exercise.
intervention type: Other
intervention name: Self Epley Manoeuvre
description: The patient has to position himself long sitting on the bed, then turn his head 45 degrees to the problematic side. When in this head position, he will rapidly lie himself supine with a pillow under his shoulders. He then turns his head 90 degrees to the opposite direction followed by turning of his body to the same side before returning to a sitting position at the edge of the bed. Each position should be kept for 30 seconds each, and the patient is required to perform 3 cycles of this manoeuvre just prior to going to bed daily for 2 weeks.
arm group label: Self Epley Manoeuvre
other name: SEM
intervention type: Other
intervention name: Brandt-Daroff Exercise
description: The patient has to sit at the edge of the bed, turn his head laterally 45 degrees to one side and move rapidly into the side lying position, keeping his head in the same position. He then returns upright and turns his head to the opposite direction and the same movement is repeated on the other side. Each position is held for at least 30 seconds and the patient is required to perform it for 5 repetitions, three times a day, daily for 2 weeks duration.
arm group label: Brandt-Daroff Exercise
other name: BDE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mazlina Mazlan, MBBS, MRM
role: Study Chair
affiliation: University Malaya
last name: Nor Hanim Mohamad Hanapi, MBBS
role: Principal Investigator
affiliation: University Malaya
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Benign Paroxysmal Positional Vertigo
mesh term: Dizziness
sharing ipd: Undecided