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Effects of Vestibular Rehabilitation Program on Dizziness, Vertigo and Balance in Population With Vertigo

Primary Purpose

Vertigo

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cawthrone and cooksey exercises,Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo focused on measuring Rehabilitation exercises, Vertigo, Balance

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and Female, Age 30-65 years.

    • BPPV diagnosis confirmed by the: 1. A specific history of vertigo/dizziness evoked by acceleration/deceleration. 2. Symptoms of vertigo during Dix Hallpike Test for Posterior Semicircular canal with or without accompanying nystagmus (objective or subjective BPPV)
    • Patients diagnosed with BPPV for at least 6 months

Exclusion Criteria:

  • Central nervous system (CNS) involvement,

    • Meniere's disease,
    • Severe eye disorder, labyrinthitis, vestibular neuritis,
    • Any unstable medical condition (e.g severe hypertension or unstable cardiac diagnosis).
    • Any Cervical pathology.
    • Orthopedic or neurologic diagnoses including sensory loss (e.g diabetes) that might affect postural control and have an impact on functional mobility.

Long-term use of benzodiazepines (more than 20 years).

  • Cognitive decline or reduced cultural level that prevents the patient from understanding the assessment, vestibular rehabilitation exercises, and granting informed consent.
  • Other Balance Disorders

Sites / Locations

  • Physiotherapy outpatient clinic of Bashir Neuro Institute.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

Caw-throne and Cooksey exercise, Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.

Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.

Outcomes

Primary Outcome Measures

Vertigo symptom Scale
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness Internal consistency (Cronbach's alpha: 0.94)
Dizziness Handicap Inventory
Self-perceived handicapping effects imposed by dizziness. Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95
Berg Balance Scale
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. ICC for total score = 0.988, Testretest reliability r = 0.98

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
April 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05392595
Brief Title
Effects of Vestibular Rehabilitation Program on Dizziness, Vertigo and Balance in Population With Vertigo
Official Title
Effects of Vestibular Rehabilitation Program on Dizziness, Vertigo and Balance in Population With Benign Paroxysmal Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (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
No

5. Study Description

Brief Summary
Benign Paroxysmal Positional Vertigo (BPPV) is characterized by short, recurrent and intense episodes of vertigo. Repositioning maneuvers have been used for its treatment however, evidence indicated recurrence with these maneuvers. However, the effectiveness of this intervention for improving dynamic and static balance in patients with BPPV is unknown. Vestibular rehabilitation through Caw-throne and Cooksey exercises improves dizziness, balance and gives postural stability. This study aims to determine effects of these exercises in improving the residual symptoms of dizziness and balance impairments after CRM. This randomized controlled trial will recruit patients through convenience sampling. Diagnosed patients of BPPV will be confirmed for inclusion through Dix-Hallpike test. Patients presenting with other neurological, orthopedic or metabolic conditions, patients who have had exposure to any balance exercises or other forms of training that can influence results will also be excluded to limit confounding factors A sample of 26 patients will be taken and divided into two groups each with 13 patients. Group A will receive conventional physical therapy while group B will receive Vestibular Rehabilitation exercises with the conventional physical therapy protocol. The conventional physical therapy protocol will include Cervical stretches and Basic Balance Exercises. The session will be around 40 min on each patient with three session per week on alternate days.The study will evaluate patients through Vertigo symptom Scale (to identify vertigo), Dizziness Handicap Inventory (to identify dizziness),Berg Balance Scale (to identify balance and risk of fall). The data will be analyzed using SPPS software.
Detailed Description
Vertigo is the perception of motion, which may be described as a sensation of swaying, tilting, spinning of environment or feeling unbalanced. Due to highly variable descriptions of vertigo, it is often consolidated into the umbrella descriptor 'dizziness', a very common complaint.Vertigo can be of vestibular or peripheral origin or be due to non-vestibular or central causes. Benign paroxysmal positional vertigo (BPPV) is the most common cause of peripheral vertigo, accounting for over half of all cases. One of the treatment options for vestibular disorders (unilateral and bilateral vestibular hypofunction and central or mixed vestibular disorders) is vestibular rehabilitation (VR). This consists of an individualized exercise program which has been developed to address the deficits identified during the physical therapy evaluation and which has been shown to be an effective treatment for patients with dizziness and balance disorders. Currently, this program includes compensatory responses, adaptation for visual-vestibular interaction, substitution and postural control exercises, fall prevention, (re)conditioning activities, and functional retraining.These exercises have been used alone or in conjunction with other vestibular approaches and have been proved effective in improving balance and decreasing fall risk (stroke), postural stability (healthy adults), balance (multiple sclerosis) and decreasing perception of disability (unilateral vestibular hypofunction). Their effectiveness on vertigo, dizziness and balance in patients with BPPV has limited evidence. The current study is designed to determine the effects of Vestibular Rehabilitation exercises on vertigo, dizziness and balance in patients with BPPV. The purpose of this study is that, it will provide the evidence which might improve the treatment strategies for the management of symptoms of BPPV and their recurrence after Canalith Repositioning Maneuver and improve the quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo
Keywords
Rehabilitation exercises, Vertigo, Balance

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Caw-throne and Cooksey exercise, Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Arm Title
Group B
Arm Type
Other
Arm Description
Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Intervention Type
Other
Intervention Name(s)
Cawthrone and cooksey exercises,Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Intervention Description
Epley "repositioning maneuver will be performed, also cervical stretches and Basic Balance exercises Following Exercises will be performed by patient in next session. Caw-Thorne and Cooksey exercise program. Participants will receive CRM for 6 weeks as needed in each evaluation. Frequency: These exercises will be performed thrice a week on alternate days for 40 min sessions. Post-Intervention Assessment: The patients will be assessed 6 weeks after the beginning of the intervention
Intervention Type
Other
Intervention Name(s)
Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Intervention Description
Conventional treatment: Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises. Frequency: Participants will receive CRM for 6 weeks as needed in each evaluation. Frequency: These exercises will be performed thrice a week on alternate days for 40 min sessions. Post-Intervention Assessment: The patients will be assessed 6 weeks after the beginning of the intervention
Primary Outcome Measure Information:
Title
Vertigo symptom Scale
Description
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness Internal consistency (Cronbach's alpha: 0.94)
Time Frame
3rd day
Title
Dizziness Handicap Inventory
Description
Self-perceived handicapping effects imposed by dizziness. Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95
Time Frame
3rd day
Title
Berg Balance Scale
Description
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. ICC for total score = 0.988, Testretest reliability r = 0.98
Time Frame
3rd day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female, Age 30-65 years. BPPV diagnosis confirmed by the: 1. A specific history of vertigo/dizziness evoked by acceleration/deceleration. 2. Symptoms of vertigo during Dix Hallpike Test for Posterior Semicircular canal with or without accompanying nystagmus (objective or subjective BPPV) Patients diagnosed with BPPV for at least 6 months Exclusion Criteria: Central nervous system (CNS) involvement, Meniere's disease, Severe eye disorder, labyrinthitis, vestibular neuritis, Any unstable medical condition (e.g severe hypertension or unstable cardiac diagnosis). Any Cervical pathology. Orthopedic or neurologic diagnoses including sensory loss (e.g diabetes) that might affect postural control and have an impact on functional mobility. Long-term use of benzodiazepines (more than 20 years). Cognitive decline or reduced cultural level that prevents the patient from understanding the assessment, vestibular rehabilitation exercises, and granting informed consent. Other Balance Disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Ikram
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy outpatient clinic of Bashir Neuro Institute.
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
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Results Reference
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PubMed Identifier
29794430
Citation
Pan Q, Zhang Y, Long T, He W, Zhang S, Fan Y, Zhou J. Diagnosis of Vertigo and Dizziness Syndromes in a Neurological Outpatient Clinic. Eur Neurol. 2018;79(5-6):287-294. doi: 10.1159/000489639. Epub 2018 May 24.
Results Reference
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PubMed Identifier
30828628
Citation
You P, Instrum R, Parnes L. Benign paroxysmal positional vertigo. Laryngoscope Investig Otolaryngol. 2018 Dec 14;4(1):116-123. doi: 10.1002/lio2.230. eCollection 2019 Feb.
Results Reference
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PubMed Identifier
33734445
Citation
Yang TH, Xirasagar S, Cheng YF, Wang CH, Lin HC. Increased Risk of Injury Following a Diagnosis of Vertigo: A Population-based Study. Laryngoscope. 2021 Jul;131(7):1633-1638. doi: 10.1002/lary.29519. Epub 2021 Mar 18.
Results Reference
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PubMed Identifier
30439765
Citation
Parker IG, Hartel G, Paratz J, Choy NL, Rahmann A. A Systematic Review of the Reported Proportions of Diagnoses for Dizziness and Vertigo. Otol Neurotol. 2019 Jan;40(1):6-15. doi: 10.1097/MAO.0000000000002044.
Results Reference
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PubMed Identifier
29803531
Citation
Alyono JC. Vertigo and Dizziness: Understanding and Managing Fall Risk. Otolaryngol Clin North Am. 2018 Aug;51(4):725-740. doi: 10.1016/j.otc.2018.03.003. Epub 2018 May 24.
Results Reference
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PubMed Identifier
33361695
Citation
Tramontano M, Consorti G, Morone G, Lunghi C. Vertigo and Balance Disorders - The Role of Osteopathic Manipulative Treatment: A Systematic Review. Complement Med Res. 2021;28(4):368-377. doi: 10.1159/000512673. Epub 2020 Dec 23.
Results Reference
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PubMed Identifier
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Citation
Bressi F, Vella P, Casale M, Moffa A, Sabatino L, Lopez MA, Carinci F, Papalia R, Salvinelli F, Sterzi S. Vestibular rehabilitation in benign paroxysmal positional vertigo: Reality or fiction? Int J Immunopathol Pharmacol. 2017 Jun;30(2):113-122. doi: 10.1177/0394632017709917. Epub 2017 May 9.
Results Reference
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PubMed Identifier
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Citation
Argaet EC, Bradshaw AP, Welgampola MS. Benign positional vertigo, its diagnosis, treatment and mimics. Clin Neurophysiol Pract. 2019 Apr 6;4:97-111. doi: 10.1016/j.cnp.2019.03.001. eCollection 2019.
Results Reference
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Citation
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Results Reference
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Effects of Vestibular Rehabilitation Program on Dizziness, Vertigo and Balance in Population With Vertigo

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