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Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self Epley Manoeuvre
Brandt-Daroff Exercise
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring vertigo, benign paroxysmal positional vertigo, particle repositioning manoeuvre

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients who have had symptoms of vertigo for at least 1 week duration,
  • patients with a documented positive Dix-Hallpike test on referral,
  • patients with intact cognitive function and had the ability to communicate and understand instructions to perform a home-based exercise.

Exclusion Criteria:

  • patients with history of prior ear surgery,
  • patients with orthopaedic or connective tissue disorder that impairs functional neck or trunk range of motion,
  • patients with a significant neurological disorder or spinal cord damage, and
  • patients who have been prescribed with home-based exercises for BPPV.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Self Epley Manoeuvre

    Brandt-Daroff Exercise

    Arm Description

    Self Epley Manoeuvre.

    Brandt-Daroff Exercise.

    Outcomes

    Primary Outcome Measures

    Vertigo resolution
    Present or absent

    Secondary Outcome Measures

    Conversion of a positive to negative Dix-Hallpike test
    Positive or negative
    Vertigo intensity
    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.
    Dizziness Handicap Inventory
    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.

    Full Information

    First Posted
    July 24, 2017
    Last Updated
    July 30, 2017
    Sponsor
    University of Malaya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03230513
    Brief Title
    Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    October 31, 2016 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Malaya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Paroxysmal Positional Vertigo
    Keywords
    vertigo, benign paroxysmal positional vertigo, particle repositioning manoeuvre

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Self Epley Manoeuvre
    Arm Type
    Active Comparator
    Arm Description
    Self Epley Manoeuvre.
    Arm Title
    Brandt-Daroff Exercise
    Arm Type
    Active Comparator
    Arm Description
    Brandt-Daroff Exercise.
    Intervention Type
    Other
    Intervention Name(s)
    Self Epley Manoeuvre
    Other Intervention Name(s)
    SEM
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Brandt-Daroff Exercise
    Other Intervention Name(s)
    BDE
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Vertigo resolution
    Description
    Present or absent
    Time Frame
    Assessed at 1 month and 6 months following initiation of home-based exercise.
    Secondary Outcome Measure Information:
    Title
    Conversion of a positive to negative Dix-Hallpike test
    Description
    Positive or negative
    Time Frame
    Assessed at 1 month following initiation of home-based exercise.
    Title
    Vertigo intensity
    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.
    Time Frame
    Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
    Title
    Dizziness Handicap Inventory
    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.
    Time Frame
    Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients who have had symptoms of vertigo for at least 1 week duration, patients with a documented positive Dix-Hallpike test on referral, patients with intact cognitive function and had the ability to communicate and understand instructions to perform a home-based exercise. Exclusion Criteria: patients with history of prior ear surgery, patients with orthopaedic or connective tissue disorder that impairs functional neck or trunk range of motion, patients with a significant neurological disorder or spinal cord damage, and patients who have been prescribed with home-based exercises for BPPV.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mazlina Mazlan, MBBS, MRM
    Organizational Affiliation
    University Malaya
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Nor Hanim Mohamad Hanapi, MBBS
    Organizational Affiliation
    University Malaya
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms

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