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Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Habituation exercises + vestibular treatment
proprioceptive training + vestibular therapy
conventional vestibular treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Habituation exercises, Proprioceptive training, Vertigo, Dizziness, Balance, benign paroxysmal positional vertigo

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • psrd (pakistan Society for the rehabilitation of the disabled

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

habituation exercises

proprioceptive training

Conventional vestibular therapy

Arm Description

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

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

Epley's Manuever

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2022
Last Updated
July 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05425199
Brief Title
Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo
Official Title
Effects of Habituation Exercises Versus Proprioceptive Training on Dizziness, Vertigo, Balance and Quality of Life in Benign Paroxysmal Positional Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
Habituation exercises, Proprioceptive training, Vertigo, Dizziness, Balance, benign paroxysmal positional vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
habituation exercises
Arm Type
Experimental
Arm Description
head and eye movements first slowly then rapidly, head and body movements e.g., picking object from the ground standing and rotation in standing
Arm Title
proprioceptive training
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional vestibular therapy
Arm Type
Active Comparator
Arm Description
Epley's Manuever
Intervention Type
Other
Intervention Name(s)
Habituation exercises + vestibular treatment
Intervention Description
Exercises will include Intensity: 10 repetitions of each set Frequency= 3 sessions per week for 6 weeks. Time= 30 minutes
Intervention Type
Other
Intervention Name(s)
proprioceptive training + vestibular therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional vestibular treatment
Intervention Description
Epley's Manuever. Frequency= It will be performed once in a week . Time= 10-15 minutes per session
Primary Outcome Measure Information:
Title
Berg balance scale
Description
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.
Time Frame
6th week
Secondary Outcome Measure Information:
Title
dynamic gait index
Description
Assess the likelihood of falling in older adults.total score is of 24.score less than 19 is predictive of fall risks.
Time Frame
6th week
Title
Dizziness handicap inventory
Description
Measure of patients perception of dizziness.subscales included are functional, physical and emotional.
Time Frame
6th week
Title
visual vertigo analogue scale
Description
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.
Time Frame
6th week
Title
Activities specific balance confidence scale
Description
Assess the older individuals balance confidence in performing daily life activities. This scale comprises of a wide continuum of less and more challenging activities.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: CNS involvement Orthopedic problem Unable to answer a simple verbal command Head injury or brain trauma Not medically diagnosed with any vestibular disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Aabroo
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
psrd (pakistan Society for the rehabilitation of the disabled
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33243182
Citation
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Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo

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