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Benign Paroxysmal Positional Vertigo (Disorder)NCT05333198

Oculomotor and Vestibular Ocular Reflex Exercises in Patients With Benign Paroxysmal Positional Vertigo

A study testing Traditional physical therapy using Epley's maneuver and Oculomotor and Vestibular Ocular Reflex (VOR) exercises in people with Benign Paroxysmal Positional Vertigo (Disorder), run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 60 years
What is being tested?
Traditional physical therapy using Epley's maneuver and Oculomotor and Vestibular Ocular Reflex (VOR) exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
15 Feb 2021to 15 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Binash Afzal

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Traditional physical therapy using Epley's maneuver, Oculomotor and Vestibular Ocular Reflex (VOR) exercises
Keywords
Benign Paroxysmal Positional Vertigo, Oculomotor exercises, Vestibular Ocular Reflex (VOR) exercises
Medical subject headings
Benign Paroxysmal Positional Vertigo, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional physical therapy using Epley's maneuverOther

    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.

  • Oculomotor and Vestibular Ocular Reflex (VOR) exercisesOther

    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

Study groups in NCT05333198
Study groupRoleWhat they receive
Traditional physical therapy using Epley's maneuverOtherEpley'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.
Receives: Other: Traditional physical therapy using Epley's maneuver
Oculomotor and Vestibular Ocular Reflex (VOR) exercisesActive comparatoroculomotor 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
Receives: Other: Oculomotor and Vestibular Ocular Reflex (VOR) exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vertigo Handicap Questionnaire

    It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.

    Measured: First reading at 0 day

  2. Vertigo Handicap Questionnaire

    It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.

    Measured: second reading after 3 weeks

  3. Visual Vertigo Analogue Scale

    Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness

    Measured: First reading at 0 day

  4. Visual Vertigo Analogue Scale

    Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness

    Measured: second reading after 3 weeks

  5. Dizziness Handicap Inventory

    Self-perceived handicapping effects imposed by dizziness.

    Measured: First reading at 0 day

  6. Dizziness Handicap Inventory

    Self-perceived handicapping effects imposed by dizziness.

    Measured: second reading after 3 weeks

  7. Berg Balance Scale

    Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks

    Measured: First reading at 0 day

  8. Berg Balance Scale

    Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks

    Measured: First reading at 3 week

  9. Dynamic Gait Index

    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.

    Measured: first reading after 0 day

  10. Dynamic Gait Index

    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.

    Measured: second reading after 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start15 Feb 2021
  3. Primary completion15 Oct 2021
  4. Study completion15 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05333198
Sponsor's protocol ID
RiphahIU Ezza Zikrea
Status last verified
Apr 2022
First submitted
21 Jan 2022
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32300888
  • 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.

    PubMed 30870365
  • 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.

    PubMed 30461465
  • 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.

    PubMed 31217316
  • 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.

    PubMed 30616293
  • 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.

    PubMed 27406654
  • 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.

    PubMed 26111348
  • 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.

    PubMed 33048219
  • 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.

    PubMed 34372958
  • 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.

    PubMed 32925126

Questions about this trial

What is this clinical trial studying?

A study testing Traditional physical therapy using Epley's maneuver and Oculomotor and Vestibular Ocular Reflex (VOR) exercises in people with Benign Paroxysmal Positional Vertigo (Disorder), run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertigo Handicap Questionnaire (time frame: First reading at 0 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05333198, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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