- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392595
Effects of Vestibular Rehabilitation Program on Dizziness, Vertigo and Balance in Population With Vertigo
Effects of Vestibular Rehabilitation Program on Dizziness, Vertigo and Balance in Population With Benign Paroxysmal Vertigo
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Punjab
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Lahore, Punjab, Pakistan, 54000
- Physiotherapy outpatient clinic of Bashir Neuro Institute.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
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 |
|---|---|
|
Experimental: Group A
Caw-throne and Cooksey exercise, Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
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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
|
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Other: Group B
Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vertigo symptom Scale
Time Frame: 3rd day
|
Intensity of visual vertigo in nine challenging situations of visual motions that typically provoke dizziness Internal consistency (Cronbach's alpha: 0.94)
|
3rd day
|
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Dizziness Handicap Inventory
Time Frame: 3rd day
|
Self-perceived handicapping effects imposed by dizziness.
Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95
|
3rd day
|
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Berg Balance Scale
Time Frame: 3rd day
|
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
|
3rd day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehwish Ikram, Riphah International University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Concha-Cisternas Y, Guzmán-Muñoz E. Vestibular rehabilitation therapy in elderly with benign paroxysmal positional vertigo. MOJ Gerontol Ger. 2020;5(1):5-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR &AHS/22/0212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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