NCT05425199

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 5, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

June 15, 2022

Last Update Submit

July 31, 2023

Conditions

Keywords

Habituation exercisesProprioceptive trainingVertigoDizzinessBalancebenign paroxysmal positional vertigo

Outcome Measures

Primary Outcomes (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.

    6th week

Secondary Outcomes (4)

  • dynamic gait index

    6th week

  • Dizziness handicap inventory

    6th week

  • visual vertigo analogue scale

    6th week

  • Activities specific balance confidence scale

    6th week

Study Arms (3)

habituation exercises

EXPERIMENTAL

head and eye movements first slowly then rapidly, head and body movements e.g., picking object from the ground standing and rotation in standing

Other: Habituation exercises + vestibular treatment

proprioceptive training

EXPERIMENTAL

Single 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

Other: proprioceptive training + vestibular therapy

Conventional vestibular therapy

ACTIVE COMPARATOR

Epley's Manuever

Other: conventional vestibular treatment

Interventions

Exercises will include Intensity: 10 repetitions of each set Frequency= 3 sessions per week for 6 weeks. Time= 30 minutes

habituation exercises

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

proprioceptive training

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

Conventional vestibular therapy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

psrd (pakistan Society for the rehabilitation of the disabled

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 33243182BACKGROUND
  • 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
  • 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.

    PMID: 30357032BACKGROUND
  • 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.

    PMID: 29689764BACKGROUND
  • 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.

    PMID: 28819615BACKGROUND
  • 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.

    PMID: 29066999BACKGROUND
  • 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.

    PMID: 30412513BACKGROUND
  • 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.

    PMID: 34191552BACKGROUND
  • 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.

    PMID: 32948896BACKGROUND
  • 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.

    PMID: 29516062BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVertigoDizziness

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sara Aabroo

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

June 5, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations