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

Primary Purpose

Benign Paroxysmal Positional Vertigo (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Traditional physical therapy using Epley's maneuver
Oculomotor and Vestibular Ocular Reflex (VOR) exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo (Disorder) focused on measuring Benign Paroxysmal Positional Vertigo, Oculomotor exercises, Vestibular Ocular Reflex (VOR) exercises

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Binash Afzal

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Traditional physical therapy using Epley's maneuver

Oculomotor and Vestibular Ocular Reflex (VOR) exercises

Arm Description

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 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

Outcomes

Primary Outcome Measures

Vertigo Handicap Questionnaire
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
Vertigo Handicap Questionnaire
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
Visual Vertigo Analogue Scale
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
Visual Vertigo Analogue Scale
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
Dizziness Handicap Inventory
Self-perceived handicapping effects imposed by dizziness.
Dizziness Handicap Inventory
Self-perceived handicapping effects imposed by dizziness.
Berg Balance Scale
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Berg Balance Scale
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
April 11, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05333198
Brief Title
Oculomotor and Vestibular Ocular Reflex Exercises in Patients With Benign Paroxysmal Positional Vertigo
Official Title
Effects of Oculomotor and Vestibular Ocular Reflex Exercises on Vertigo, Dizziness and Balance in Patients With Benign Paroxysmal Positional Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo (Disorder)
Keywords
Benign Paroxysmal Positional Vertigo, Oculomotor exercises, Vestibular Ocular Reflex (VOR) exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional physical therapy using Epley's maneuver
Arm Type
Other
Arm Description
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.
Arm Title
Oculomotor and Vestibular Ocular Reflex (VOR) exercises
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy using Epley's maneuver
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oculomotor and Vestibular Ocular Reflex (VOR) exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Vertigo Handicap Questionnaire
Description
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
Time Frame
First reading at 0 day
Title
Vertigo Handicap Questionnaire
Description
It assess effect of vertigo on disability, handicap and benefits following therapeutic intervention both physically and psychologically.
Time Frame
second reading after 3 weeks
Title
Visual Vertigo Analogue Scale
Description
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
Time Frame
First reading at 0 day
Title
Visual Vertigo Analogue Scale
Description
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness
Time Frame
second reading after 3 weeks
Title
Dizziness Handicap Inventory
Description
Self-perceived handicapping effects imposed by dizziness.
Time Frame
First reading at 0 day
Title
Dizziness Handicap Inventory
Description
Self-perceived handicapping effects imposed by dizziness.
Time Frame
second reading after 3 weeks
Title
Berg Balance Scale
Description
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Time Frame
First reading at 0 day
Title
Berg Balance Scale
Description
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Time Frame
First reading at 3 week
Title
Dynamic Gait Index
Description
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.
Time Frame
first reading after 0 day
Title
Dynamic Gait Index
Description
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.
Time Frame
second reading after 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Binash Afzal
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32300888
Citation
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.
Results Reference
background
PubMed Identifier
30870365
Citation
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.
Results Reference
background
PubMed Identifier
30461465
Citation
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.
Results Reference
background
PubMed Identifier
31217316
Citation
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.
Results Reference
background
PubMed Identifier
30616293
Citation
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.
Results Reference
background
PubMed Identifier
27406654
Citation
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.
Results Reference
background
PubMed Identifier
26111348
Citation
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.
Results Reference
background
PubMed Identifier
33048219
Citation
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.
Results Reference
background
PubMed Identifier
34372958
Citation
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.
Results Reference
background
PubMed Identifier
32925126
Citation
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.
Results Reference
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Oculomotor and Vestibular Ocular Reflex Exercises in Patients With Benign Paroxysmal Positional Vertigo

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