NCT05392595

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

April 18, 2023

Conditions

Keywords

Rehabilitation exercisesVertigoBalance

Outcome Measures

Primary Outcomes (3)

  • 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)

    3rd day

  • Dizziness Handicap Inventory

    Self-perceived handicapping effects imposed by dizziness. Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95

    3rd day

  • 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

    3rd day

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Cawthrone and cooksey exercises,Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.

Group B

OTHER

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

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

Interventions

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

Group A

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

Group B

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy outpatient clinic of Bashir Neuro Institute.

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
  • 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.

    PMID: 29794430BACKGROUND
  • 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.

    PMID: 30828628BACKGROUND
  • 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.

    PMID: 33734445BACKGROUND
  • 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.

    PMID: 30439765BACKGROUND
  • 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.

    PMID: 29803531BACKGROUND
  • 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.

    PMID: 33361695BACKGROUND
  • 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.

    PMID: 28485653BACKGROUND
  • 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.

    PMID: 31193795BACKGROUND
  • Concha-Cisternas Y, Guzmán-Muñoz E. Vestibular rehabilitation therapy in elderly with benign paroxysmal positional vertigo. MOJ Gerontol Ger. 2020;5(1):5-8.

    BACKGROUND

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehwish Ikram

    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

May 23, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations