- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05333198
Oculomotor and Vestibular Ocular Reflex Exercises in Patients With Benign Paroxysmal Positional Vertigo
April 11, 2022 updated by: Riphah International University
Effects of Oculomotor and Vestibular Ocular Reflex Exercises on Vertigo, Dizziness and Balance in Patients With Benign Paroxysmal Positional Vertigo
The aim of this research is to assess effects of Oculomotor and VOR exercises on vertigo, dizziness and balance in patients with BPPV.
Randomized controlled trial was conducted at Hameed Latif Hospital, Lahore.
The sample size 32 participants which were divided into two groups, 16 participants in traditional physical therapy group and 16 in oculomotor and vestibular ocular reflex exercises group.
Study duration was of 6 months.
Sampling technique applied was non-probability consecutive sampling technique.
Only 30-70 years individuals with Benign Paroxysmal Positional Vertigo (BPPV) were included.
Tools used in the study are vertigo handicap questionnaire, visual vertigo analogue scale, dizziness handicap inventory, berg balance scale and dynamic gait index.
The data was analyzed using SPSS.
Study Overview
Status
Completed
Detailed Description
Randomized controlled trial was conducted at Hameed Latif Hospital, Lahore.
The sample size 32 participants which were divided into two groups, 16 participants in traditional physical therapy group and 16 in oculomotor and vestibular ocular reflex exercises group.
Study duration was of 6 months.
Sampling technique applied was non-probability consecutive sampling technique.
Only 30-70 years individuals with Benign Paroxysmal Positional Vertigo (BPPV) were included.
Tools used in the study are vertigo handicap questionnaire, visual vertigo analogue scale, dizziness handicap inventory, berg balance scale and dynamic gait index.
The data was analyzed using SPSS.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Binash Afzal
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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
Ages Eligible for Study
26 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who have vertigo with posterior canal involvement during Dix-Hallpike test with or without accompanying nystagmus (objective or subjective BPPV).
- Ability to walk at least 3 meters by itself with or without assistive device
- Normal vision with or without correction by spectacles or contact lenses
Exclusion Criteria:
- Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases to eliminate confounding factors affecting balance performance
- Unable to understand and answer a simple verbal command.
- Previously underwent oculomotor and vestibular ocular exercises.
- Other vestibular disorders like Meniere disease
- Long-term use of benzodiazepines (more than 20 years).
- Patients who are already performing structured physical activities such as muscle strengthening exercises, Pilates, yoga or high intensity aerobic exercises
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 |
Intervention / Treatment |
|---|---|
|
Other: Traditional physical therapy using Epley's maneuver
Epley's maneuver was performed once a week for three weeks.
The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side.
Each position was maintained for 1-2 minutes.
|
Epley's maneuver was performed once a week for three weeks.
The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side.
Each position was maintained for 1-2 minutes.
|
|
Active Comparator: Oculomotor and Vestibular Ocular Reflex (VOR) exercises
oculomotor and VOR exercises after Epley's maneuver.
The exercises were performed for approximately 5 minutes daily or 1 to 2 minutes, 3 to 4 times a day, in sitting position.
The exercises were continued for three weeks.
The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side.
Each position was maintained for 1-2 minutes.
Saccadic exercises were performed by moving eyes between two stationary targets.
Smooth pursuit exercises were performed by tracking a moving target while keeping head still and VOR exercises were performed by moving head left to right while maintaining eyes on stationary target
|
oculomotor and VOR exercises after Epley's maneuver.
The exercises were performed for approximately 5 minutes daily or 1 to 2 minutes, 3 to 4 times a day, in sitting position.
The exercises were continued for three weeks.
The maneuver was performed by patient in sitting position, head was rotated towards involved side and then extended to 30 degrees, it was then rotated to 180 degrees followed by patient rolling onto opposite side.
Each position was maintained for 1-2 minutes.
Saccadic exercises were performed by moving eyes between two stationary targets.
Smooth pursuit exercises were performed by tracking a moving target while keeping head still and VOR exercises were performed by moving head left to right while maintaining eyes on stationary target
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vertigo Handicap Questionnaire
Time Frame: First reading at 0 day
|
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
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First reading at 0 day
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Vertigo Handicap Questionnaire
Time Frame: second reading after 3 weeks
|
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
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second reading after 3 weeks
|
|
Visual Vertigo Analogue Scale
Time Frame: First reading at 0 day
|
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
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First reading at 0 day
|
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Visual Vertigo Analogue Scale
Time Frame: second reading after 3 weeks
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Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
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second reading after 3 weeks
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Dizziness Handicap Inventory
Time Frame: First reading at 0 day
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Self-perceived handicapping effects imposed by dizziness.
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First reading at 0 day
|
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Dizziness Handicap Inventory
Time Frame: second reading after 3 weeks
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Self-perceived handicapping effects imposed by dizziness.
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second reading after 3 weeks
|
|
Berg Balance Scale
Time Frame: First reading at 0 day
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Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
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First reading at 0 day
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Berg Balance Scale
Time Frame: First reading at 3 week
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Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
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First reading at 3 week
|
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Dynamic Gait Index
Time Frame: first reading after 0 day
|
The clinical tool to assess gait, balance and fall risk.
It evaluates not only usual steady-state walking, but also walking during more challenging tasks.
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first reading after 0 day
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Dynamic Gait Index
Time Frame: second reading after 3 weeks
|
The clinical tool to assess gait, balance and fall risk.
It evaluates not only usual steady-state walking, but also walking during more challenging tasks.
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second reading after 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dunlap PM, Holmberg JM, Whitney SL. Vestibular rehabilitation: advances in peripheral and central vestibular disorders. Curr Opin Neurol. 2019 Feb;32(1):137-144. doi: 10.1097/WCO.0000000000000632.
- Kim HJ, Lee JO, Choi JY, Kim JS. Etiologic distribution of dizziness and vertigo in a referral-based dizziness clinic in South Korea. J Neurol. 2020 Aug;267(8):2252-2259. doi: 10.1007/s00415-020-09831-2. Epub 2020 Apr 16.
- Scocco DH, Garcia IE, Barreiro MA. Sitting Up Vertigo. Proposed Variant of Posterior Canal Benign Paroxysmal Positional Vertigo. Otol Neurotol. 2019 Apr;40(4):497-503. doi: 10.1097/MAO.0000000000002157.
- Wu P, Cao W, Hu Y, Li H. Effects of vestibular rehabilitation, with or without betahistine, on managing residual dizziness after successful repositioning manoeuvres in patients with benign paroxysmal positional vertigo: a protocol for a randomised controlled trial. BMJ Open. 2019 Jun 18;9(6):e026711. doi: 10.1136/bmjopen-2018-026711.
- Kane AW, Diaz DS, Moore C. Physical Therapy Management of Adults with Mild Traumatic Brain Injury. Semin Speech Lang. 2019 Feb;40(1):36-47. doi: 10.1055/s-0038-1676652. Epub 2019 Jan 7.
- Hillier S, McDonnell M. Is vestibular rehabilitation effective in improving dizziness and function after unilateral peripheral vestibular hypofunction? An abridged version of a Cochrane Review. Eur J Phys Rehabil Med. 2016 Aug;52(4):541-56. Epub 2016 Jul 12.
- Arnold SA, Stewart AM, Moor HM, Karl RC, Reneker JC. The Effectiveness of Vestibular Rehabilitation Interventions in Treating Unilateral Peripheral Vestibular Disorders: A Systematic Review. Physiother Res Int. 2017 Jul;22(3). doi: 10.1002/pri.1635. Epub 2015 Jun 25.
- Meldrum D, Burrows L, Cakrt O, Kerkeni H, Lopez C, Tjernstrom F, Vereeck L, Zur O, Jahn K. Vestibular rehabilitation in Europe: a survey of clinical and research practice. J Neurol. 2020 Dec;267(Suppl 1):24-35. doi: 10.1007/s00415-020-10228-4. Epub 2020 Oct 13.
- Mempouo E, Lau K, Green F, Bowes C, Ray J. Customised vestibular rehabilitation with the addition of virtual reality based therapy in the management of persistent postural-perceptual dizziness. J Laryngol Otol. 2021 Oct;135(10):887-891. doi: 10.1017/S0022215121002127. Epub 2021 Aug 10.
- Lin SI, Tsai YJ, Lee PY. Balance performance when responding to visual stimuli in patients with Benign Paroxysmal Positional Vertigo (BPPV). J Vestib Res. 2020;30(4):267-274. doi: 10.3233/VES-200709.
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)
February 15, 2021
Primary Completion (Actual)
October 15, 2021
Study Completion (Actual)
December 15, 2021
Study Registration Dates
First Submitted
January 21, 2022
First Submitted That Met QC Criteria
April 11, 2022
First Posted (Actual)
April 18, 2022
Study Record Updates
Last Update Posted (Actual)
April 18, 2022
Last Update Submitted That Met QC Criteria
April 11, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU Ezza Zikrea
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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