NCT05333198

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

January 21, 2022

Last Update Submit

April 11, 2022

Conditions

Keywords

Benign Paroxysmal Positional VertigoOculomotor exercisesVestibular Ocular Reflex (VOR) exercises

Outcome Measures

Primary Outcomes (10)

  • Vertigo Handicap Questionnaire

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

    First reading at 0 day

  • Vertigo Handicap Questionnaire

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

    second reading after 3 weeks

  • Visual Vertigo Analogue Scale

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

    First reading at 0 day

  • Visual Vertigo Analogue Scale

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

    second reading after 3 weeks

  • Dizziness Handicap Inventory

    Self-perceived handicapping effects imposed by dizziness.

    First reading at 0 day

  • Dizziness Handicap Inventory

    Self-perceived handicapping effects imposed by dizziness.

    second reading after 3 weeks

  • Berg Balance Scale

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

    First reading at 0 day

  • Berg Balance Scale

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

    First reading at 3 week

  • 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.

    first reading after 0 day

  • 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.

    second reading after 3 weeks

Study Arms (2)

Traditional physical therapy using Epley's maneuver

OTHER

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.

Other: Traditional physical therapy using Epley's maneuver

Oculomotor and Vestibular Ocular Reflex (VOR) exercises

ACTIVE COMPARATOR

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

Other: Oculomotor and Vestibular Ocular Reflex (VOR) exercises

Interventions

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.

Traditional physical therapy using Epley's maneuver

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 Vestibular Ocular Reflex (VOR) exercises

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash Afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 32300888BACKGROUND
  • 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.

    PMID: 30870365BACKGROUND
  • 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.

    PMID: 30461465BACKGROUND
  • 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.

    PMID: 31217316BACKGROUND
  • 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.

    PMID: 30616293BACKGROUND
  • 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.

    PMID: 27406654BACKGROUND
  • 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.

    PMID: 26111348BACKGROUND
  • 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.

    PMID: 33048219BACKGROUND
  • 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.

    PMID: 34372958BACKGROUND
  • 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.

    PMID: 32925126BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoMotor Activity

Interventions

Reflex, Vestibulo-OcularExercise

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaReflexNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological Phenomena

Study Officials

  • Binash Afzal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

April 18, 2022

Study Start

February 15, 2021

Primary Completion

October 15, 2021

Study Completion

December 15, 2021

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations