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
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
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
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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