- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230513
Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Self Epley Manoeuvre
Self Epley Manoeuvre.
|
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.
Other Names:
|
Active Comparator: Brandt-Daroff Exercise
Brandt-Daroff Exercise.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertigo resolution
Time Frame: Assessed at 1 month and 6 months following initiation of home-based exercise.
|
Present or absent
|
Assessed at 1 month and 6 months following initiation of home-based exercise.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion of a positive to negative Dix-Hallpike test
Time Frame: Assessed at 1 month following initiation of home-based exercise.
|
Positive or negative
|
Assessed at 1 month following initiation of home-based exercise.
|
Vertigo intensity
Time Frame: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
|
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.
|
Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
|
Dizziness Handicap Inventory
Time Frame: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
|
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.
|
Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mazlina Mazlan, MBBS, MRM, University Malaya
- Principal Investigator: Nor Hanim Mohamad Hanapi, MBBS, University Malaya
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MREC ID NO: 20155-1337
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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