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

July 30, 2017 updated by: University of Malaya

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Self Epley Manoeuvre
Self Epley Manoeuvre.
Other: 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:
  • SEM
Active Comparator: Brandt-Daroff Exercise
Brandt-Daroff Exercise.
Other: 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:
  • BDE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mazlina Mazlan, MBBS, MRM, University Malaya
  • Principal Investigator: Nor Hanim Mohamad Hanapi, MBBS, University Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MREC ID NO: 20155-1337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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