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

NCT03230513 | Completed

• 1 other identifier: MREC ID NO: 20155-1337
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

vertigo; benign paroxysmal positional vertigo; particle repositioning manoeuvre

Outcome Measures

Primary Outcomes (1)

• Vertigo resolution

  Present or absent

  Assessed at 1 month and 6 months following initiation of home-based exercise.

Secondary Outcomes (3)

• Conversion of a positive to negative Dix-Hallpike test

  Assessed at 1 month following initiation of home-based exercise.

• Vertigo intensity

  Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.

• Dizziness Handicap Inventory

  Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.

Study Arms (2)

Self Epley Manoeuvre

ACTIVE COMPARATOR

Self Epley Manoeuvre.

Other: Self Epley Manoeuvre

Brandt-Daroff Exercise

ACTIVE COMPARATOR

Brandt-Daroff Exercise.

Other: Brandt-Daroff Exercise

Interventions

Self Epley Manoeuvre OTHER

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.

Also known as: SEM

Self Epley Manoeuvre

Brandt-Daroff Exercise OTHER

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.

Also known as: BDE

Brandt-Daroff Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mazlina Mazlan, MBBS, MRM

  University of Malaya

  STUDY CHAIR

• Nor Hanim Mohamad Hanapi, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: October 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: May 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07