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VertigoNCT05392595

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

A study testing Cawthrone and cooksey exercises,Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises. and Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises. in people with Vertigo, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Vertigo
What is being tested?
Cawthrone and cooksey exercises,Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises. and Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 sitePakistan
Study dates
30 May 2022to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Physiotherapy outpatient clinic of Bashir Neuro Institute.

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects of Vestibular Rehabilitation Program on Dizziness, Vertigo and Balance in Population With Benign Paroxysmal Vertigo

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.

Read the 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.

Conditions
Vertigo
Being tested
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.
Keywords
Rehabilitation exercises, Vertigo, Balance
Medical subject headings
Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

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

    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

Study groups in NCT05392595
Study groupRoleWhat they receive
Group AExperimentalCaw-throne and Cooksey exercise, Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Receives: Other: Cawthrone and cooksey exercises,Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Group BOtherEpley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.
Receives: Other: Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 3rd day

  2. Dizziness Handicap Inventory

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

    Measured: 3rd day

  3. 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

    Measured: 3rd day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start30 May 2022
  3. Primary completion30 Dec 2022
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05392595
Sponsor's protocol ID
REC/RCR &AHS/22/0212
Status last verified
Apr 2023
First submitted
23 May 2022
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32300888
  • 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.

    PubMed 29794430
  • 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.

    PubMed 30828628
  • 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.

    PubMed 33734445
  • 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.

    PubMed 30439765
  • 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.

    PubMed 29803531
  • 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.

    PubMed 33361695
  • 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.

    PubMed 28485653
  • 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Cawthrone and cooksey exercises,Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises. and Epley's repositioning maneuver will be performed also cervical stretches with basic balance exercises. in people with Vertigo, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vertigo symptom Scale (time frame: 3rd day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05392595, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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