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Benign Paroxysmal Positional VertigoNCT05425199

Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo

A study testing Habituation exercises + vestibular treatment, proprioceptive training + vestibular therapy and conventional vestibular treatment in people with Benign Paroxysmal Positional 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

The aim of this research is to compare the effects of habituation exercises versus proprioceptive training on vertigo, balance, dizziness and quality of life in the individuals having benign paroxysmal positional vertigo. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Benign Paroxysmal Positional Vertigo
What is being tested?
Habituation exercises + vestibular treatment, proprioceptive training + vestibular therapy and conventional vestibular treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 sitePakistan
Study dates
5 Jun 2022to 28 Feb 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

  • Chronic vestibular disorder
  • Diagnosed BPPV patients
  • Normal vision
  • Score of > 1 on VAS for vertigo
  • Score of > 50 on DHI questionnaire
  • Ability to follow the command

Who cannot join

  • CNS involvement
  • Orthopedic problem
  • Unable to answer a simple verbal command
  • Head injury or brain trauma
  • Not medically diagnosed with any vestibular disorder

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • psrd (pakistan Society for the rehabilitation of the disabled

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects of Habituation Exercises Versus Proprioceptive Training on Dizziness, Vertigo, Balance and Quality of Life in Benign Paroxysmal Positional Vertigo

The aim of this research is to compare the effects of habituation exercises versus proprioceptive training on vertigo, balance, dizziness and quality of life in the individuals having benign paroxysmal positional vertigo. A randomized controlled trial that will include total 39 participants .The first group will receive habituation exercises for six weeks, three times per week for thirty minutes, along with conventional vestibular rehabilitation therapy. The second group will receive proprioceptive training for six weeks, three times per week for 30 minutes, along with vestibular rehabilitation therapy. The third group will only receive vestibular rehabilitation therapy. Data collected will be analyzed through SPSS 25.

Read the detailed description

Benign paroxysmal positional vertigo is the most common presentation of peripheral vestibular disorder characterized by features like vertigo, nausea, vomiting, imbalance and increased risk of fall . Among all vestibular disorders, BPPV accounts for almost 20% and mostly affects the female gender as compared to the male gender. This type of disorder mainly involves the remoteness of otoliths in the semi-circular canal; most commonly the posterior canal is involved.

A comparative study on posterior canal BPPV including modified Epley procedure alone and Epley procedure combined with vestibular rehabilitation. This cross sectional study illustrated that the results of Epley maneuver only were as same as effectual as with VRT(vestibular Rehabilitation therapy) by reducing the symptoms of residual unsteadiness in that particular population. Among all vertiginous disorders BPPV is most common. Vestibular rehabilitation was conducted as therapeutic option and its effects on balance and quality of life were being assessed. Dizziness Handicap Inventory was being used as outcome measure scale.

The difference in signs of dizziness and quality of life in benign paroxysmal positional vertigo were investigated. Three groups were taken including one with BPPV, the second one with balance deficits (non-BPPV) and the last group involved healthy participants. The study concluded that the patients with BPPV had reduced HRQOL (health related Quality of life), tiredness and increased risk of fall. Dizziness associated with bed mobility is an indicator for the need of diagnoses and treatment thus, repositioning maneuvers had good impact on reducing the severity.

The effects of conventional vestibular rehabilitation recurrence rates on benign paroxysmal positional vertigo aimed to find the impacts on otolith dysfunction. Although repositioning movements were proved fruitful yet the recurrence rates were high in older population as compared to young. Vestibular therapy including habituation exercises decreases the risks of recurrence in benign paroxysmal positional vertigo.

As balance impairments are common in individuals with vertigo and dizziness. Proprioceptive training was proved more efficient than vestibular therapy in reducing the chances of fall in elder population. BBS (berg balance scale) and TUG (Time up and Go test) were conducted to assess balance and risk of fall in older people.

Systematic review of the previous literature on the efficacy of vestibular rehabilitation therapy in benign paroxysmal positional vertigo.12 studies were based on inclusion criteria and the effectiveness of vestibular rehabilitation only and in combination with repositioning maneuver and also in comparison with it. Habituation exercises were included in VR therapeutic intervention, Conclusion were in favor of vestibular therapy as it showed reduction in discomfort caused by the condition.

Efficacy of vestibular therapy protocol to determine its effects on quality of life and postural balance. Randomized controlled trial was performed on 20 individuals. Outcome measure scales like DHI (dizziness handicap inventory), VAS (vertigo visual analogue scale) were used and it was observed that with vestibular rehabilitation there were consequences like better quality of life and reduced signs of vertigo and dizziness were achieved.

According to previous study there was a lack of control group in previous evidence whereas this study will focus on control as well as interventional groups. In previous literature, both of these therapeutic options i.e., habituation exercises and proprioceptive training were used in combination but in this study the comparison will be done between two exercise protocols.

Consequences will be manipulated for balance, vertigo, dizziness and quality of life.

Being tested
Habituation exercises + vestibular treatment, proprioceptive training + vestibular therapy, conventional vestibular treatment
Keywords
Habituation exercises, Proprioceptive training, Vertigo, Dizziness, Balance, benign paroxysmal positional vertigo
Medical subject headings
Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness

What participants receive

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

  • Habituation exercises + vestibular treatmentOther

    Exercises will include Intensity: 10 repetitions of each set Frequency= 3 sessions per week for 6 weeks.

    Time= 30 minutes

  • proprioceptive training + vestibular therapyOther

    Exercise protocol will include Time= total session of 30 minutes . Each exercise will be hold for 30 seconds . Frequency= 3 session per week for 6 weeks Intensity= 10 repetitions and 3 sets

  • conventional vestibular treatmentOther

    Epley's Manuever. Frequency= It will be performed once in a week . Time= 10-15 minutes per session

Study groups in NCT05425199
Study groupRoleWhat they receive
habituation exercisesExperimentalhead and eye movements first slowly then rapidly, head and body movements e.g., picking object from the ground standing and rotation in standing
Receives: Other: Habituation exercises + vestibular treatment
proprioceptive trainingExperimentalSingle leg stance (right side) + Single leg stance (left side) Lifting of right knee as high as comfortable and then alternative knee Tandem walking ,Toe walking ,Heel walking
Receives: Other: proprioceptive training + vestibular therapy
Conventional vestibular therapyActive comparatorEpley's Manuever
Receives: Other: conventional vestibular treatment

What is being measured

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

  1. Berg balance scale

    Consists of 14 tasks and total score of 56.score of 0-20 indicates severe fall risk, 20-45 includes moderate risk of fall and 45-60 illustrates thr functional balances state.

    Measured: 6th week

Secondary outcomes (4)
  1. dynamic gait index

    Assess the likelihood of falling in older adults.total score is of 24.score less than 19 is predictive of fall risks.

    Measured: 6th week

  2. Dizziness handicap inventory

    Measure of patients perception of dizziness.subscales included are functional, physical and emotional.

    Measured: 6th week

  3. visual vertigo analogue scale

    This scale rates the intensity of visual vertigo in nine challenging situations of visual motions and categorized as having no (0), Mild (0.1-40), moderate (40.01-70) or severe (70.01-100) symptoms.

    Measured: 6th week

  4. Activities specific balance confidence scale

    Assess the older individuals balance confidence in performing daily life activities. This scale comprises of a wide continuum of less and more challenging activities.

    Measured: 6th week

Timeline

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

  1. First posted21 Jun 2022
  2. Study start5 Jun 2022
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 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
Double blind
Who is masked
Participant, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425199
Sponsor's protocol ID
REC/22/0221 Nirmal Javed
Status last verified
Jul 2023
First submitted
15 Jun 2022
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marsden J, Pavlou M, Dennett R, Gibbon A, Knight-Lozano R, Jeu L, Flavell C, Freeman J, Bamiou DE, Harris C, Hawton A, Goodwin E, Jones B, Creanor S. Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo. BMC Neurol. 2020 Nov 27;20(1):430. doi: 10.1186/s12883-020-01983-y.

    PubMed 33243182
  • 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
  • Rodrigues DL, Ledesma ALL, de Oliveira CAP, Bahamad Junior F. Physical Therapy for Posterior and Horizontal Canal Benign Paroxysmal Positional Vertigo: Long-term Effect and Recurrence: A Systematic Review. Int Arch Otorhinolaryngol. 2018 Oct;22(4):455-459. doi: 10.1055/s-0037-1604345. Epub 2017 Aug 28.

    PubMed 30357032
  • Roller RA, Hall CD. A speed-based approach to vestibular rehabilitation for peripheral vestibular hypofunction: A retrospective chart review. J Vestib Res. 2018;28(3-4):349-357. doi: 10.3233/VES-180633.

    PubMed 29689764
  • Bayat A, Saki N. Effects of Vestibular Rehabilitation Interventions in the Elderly with Chronic Unilateral Vestibular Hypofunction. Iran J Otorhinolaryngol. 2017 Jul;29(93):183-188.

    PubMed 28819615
  • Colnaghi S, Rezzani C, Gnesi M, Manfrin M, Quaglieri S, Nuti D, Mandala M, Monti MC, Versino M. Validation of the Italian Version of the Dizziness Handicap Inventory, the Situational Vertigo Questionnaire, and the Activity-Specific Balance Confidence Scale for Peripheral and Central Vestibular Symptoms. Front Neurol. 2017 Oct 10;8:528. doi: 10.3389/fneur.2017.00528. eCollection 2017.

    PubMed 29066999
  • Tramontano M, Martino Cinnera A, Manzari L, Tozzi FF, Caltagirone C, Morone G, Pompa A, Grasso MG. Vestibular rehabilitation has positive effects on balance, fatigue and activities of daily living in highly disabled multiple sclerosis people: A preliminary randomized controlled trial. Restor Neurol Neurosci. 2018;36(6):709-718. doi: 10.3233/RNN-180850.

    PubMed 30412513
  • Heydari M, Ahadi M, Jalaei B, Maarefvand M, Talebi H. The Additional Effect of Vestibular Rehabilitation Therapy on Residual Dizziness After Successful Modified Epley Procedure for Posterior Canal Benign Paroxysmal Positional Vertigo. Am J Audiol. 2021 Sep 10;30(3):535-543. doi: 10.1044/2021_AJA-20-00171. Epub 2021 Jun 30.

    PubMed 34191552
  • Lindell E, Kollen L, Johansson M, Karlsson T, Ryden L, Falk Erhag H, Wetterberg H, Zettergren A, Skoog I, Finizia C. Benign paroxysmal positional vertigo, dizziness, and health-related quality of life among older adults in a population-based setting. Eur Arch Otorhinolaryngol. 2021 May;278(5):1637-1644. doi: 10.1007/s00405-020-06357-1. Epub 2020 Sep 19.

    PubMed 32948896
  • Traboulsi H, Teixido M. Qualitative analysis of the Dix-Hallpike maneuver in multi-canal BPPV using a biomechanical model: Introduction of an expanded Dix-Hallpike maneuver for enhanced diagnosis of multi-canal BPPV. World J Otorhinolaryngol Head Neck Surg. 2017 Jun 8;3(3):163-168. doi: 10.1016/j.wjorl.2017.01.005. eCollection 2017 Sep.

    PubMed 29516062

Questions about this trial

What is this clinical trial studying?

A study testing Habituation exercises + vestibular treatment, proprioceptive training + vestibular therapy and conventional vestibular treatment in people with Benign Paroxysmal Positional 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 6 inclusion and 5 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 1 Aug 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?

Berg balance scale (time frame: 6th week). 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 NCT05425199, 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 1 Aug 2023.

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