search
Back to results

Whole Body Vibration In Vestibular Rehabilitation (WBV)

Primary Purpose

Vestibular Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disease focused on measuring Vestibular rehabilitation, Vestibular weakness, Whole Body Vibration, Biofeedback, Posturography

Eligibility Criteria

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

Inclusion Criteria:

Adult patients who had unilateral vestibular weakness and persistent dizziness at least two months after acute period were included Bithermal caloric test showing hyporesponsiveness higher than 30% or unresponsiveness of the horizontal canal of the affected ear accepted as unilateral vestibular weakness.

Exclusion Criteria:

Bilateral vestibular weakness, Recurrent vestibulopathy, Benign paroxysmal positional vertigo, Concomitant neurological or psychiatric disease, Severe visual or auditory impairments and orthopedic problems in the lower extremities

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Home based vestibular rehabilitation program

Biofeedback training

Whole body vibration

Arm Description

Home-based vestibular rehabilitation program including vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises was given to each group in the form of a booklet. All exercises were demonstrated and performed first time at hospital under supervision. Booklet with descriptions and pictures of each exercise were given to patients in order to enable them to perform exercises at home. Vestibular rehabilitation exercises were prescribed as once daily with 10 repetitions at home for one month and wanted to mark a chart if the exercises were performed daily. A diary was used to monitor adherence with the program.

Biofeedback training was performed five days a week during a month for 20 minutes for a total of 20 sessions with Tetrax ® (Sunlight Medical Ltd) static posture analysis device. Biofeedback training including "catch, speedball, sky ball, gotcha" exercises which requires following a visual target during weight transfer movements, capturing fast-moving objects by changing the center of gravity or quickly escaping from incoming objects, were applied to the patients in biofeedback training. There is a 30 seconds pause between each exercise.

Whole body vibration training was also performed five days a week during a month for 20 minutes for a total of 20 sessions with Power Plate Pro 5 (MDD CE 0086). In whole body vibration, single leg, squat and deep squat positions were applied respectively with 35 Hz frequency, including rest periods of 30 seconds between each application.

Outcomes

Primary Outcome Measures

fall risk
fall risk yielded by static posturography
Berg balance scale
BBS consists of 14 tasks that are each scored on a scale of 0-4, for a total possible score of 56, indicating no identified balance difficulties. Scoring is on a 5-point ordinal scale with 0 indicating an inability to complete the task and 4 as independent in completing the task.
Timed Up-and-Go
TUG is a balance and gait index which requires subjects to rise from an armchair, walk 3 m at a normal and safe pace, turn around, walk back to the chair and sit-down. The time required to complete this task is measured in seconds.
vertigo visual analogue scale
A vertically oriented 10 cm line was used for VAS, where "no vertigo" corresponds to the bottom of the line and "the worst vertigo that they could imagine" corresponds to the top of the line. Patients were instructed to place a mark on the 10-cm vertical line according to severity of their vertigo.
Dizziness Handicap Inventory
The DHI has 25 items, sub-grouped into three domains: functional, emotional, and physical. There are three closed-form answers where patients may check one of the following: yes, sometimes and no with the corresponding scored as 4/2/0. It is possible to use both the total score and the scores of the three subscales separately.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2019
Last Updated
June 11, 2022
Sponsor
Pamukkale University
search

1. Study Identification

Unique Protocol Identification Number
NCT03973255
Brief Title
Whole Body Vibration In Vestibular Rehabilitation
Acronym
WBV
Official Title
Efficacy Of Biofeedback Training And Whole Body Vibration Therapy In Vestibular Rehabilitation Of Unilateral Vestibular Weakness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale 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 study was to compare the efficacy of home based vestibular rehabilitation program, posturographic biofeedback training and whole body vibration therapy on balance, fall risk, functional mobility, vertigo symptom severity and functions in patients with unilateral vestibular weakness.
Detailed Description
A total of 90 patients who were diagnosed as unilateral vestibular weakness were included in this prospective randomized controlled study. They were randomized into three groups each consisting of 30 patients. Home based vestibular rehabilitation program was given to all groups. Fall risk yielded by posturography, Berg balance scale, Timed Up-and-Go test, vertigo visual analogue scale and Dizziness Handicap Inventory were used for comparison.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disease
Keywords
Vestibular rehabilitation, Vestibular weakness, Whole Body Vibration, Biofeedback, Posturography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home based vestibular rehabilitation program
Arm Type
Placebo Comparator
Arm Description
Home-based vestibular rehabilitation program including vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises was given to each group in the form of a booklet. All exercises were demonstrated and performed first time at hospital under supervision. Booklet with descriptions and pictures of each exercise were given to patients in order to enable them to perform exercises at home. Vestibular rehabilitation exercises were prescribed as once daily with 10 repetitions at home for one month and wanted to mark a chart if the exercises were performed daily. A diary was used to monitor adherence with the program.
Arm Title
Biofeedback training
Arm Type
Active Comparator
Arm Description
Biofeedback training was performed five days a week during a month for 20 minutes for a total of 20 sessions with Tetrax ® (Sunlight Medical Ltd) static posture analysis device. Biofeedback training including "catch, speedball, sky ball, gotcha" exercises which requires following a visual target during weight transfer movements, capturing fast-moving objects by changing the center of gravity or quickly escaping from incoming objects, were applied to the patients in biofeedback training. There is a 30 seconds pause between each exercise.
Arm Title
Whole body vibration
Arm Type
Active Comparator
Arm Description
Whole body vibration training was also performed five days a week during a month for 20 minutes for a total of 20 sessions with Power Plate Pro 5 (MDD CE 0086). In whole body vibration, single leg, squat and deep squat positions were applied respectively with 35 Hz frequency, including rest periods of 30 seconds between each application.
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation
Intervention Description
Posturography, Whole body vibration
Primary Outcome Measure Information:
Title
fall risk
Description
fall risk yielded by static posturography
Time Frame
30 days
Title
Berg balance scale
Description
BBS consists of 14 tasks that are each scored on a scale of 0-4, for a total possible score of 56, indicating no identified balance difficulties. Scoring is on a 5-point ordinal scale with 0 indicating an inability to complete the task and 4 as independent in completing the task.
Time Frame
30 days
Title
Timed Up-and-Go
Description
TUG is a balance and gait index which requires subjects to rise from an armchair, walk 3 m at a normal and safe pace, turn around, walk back to the chair and sit-down. The time required to complete this task is measured in seconds.
Time Frame
30 days
Title
vertigo visual analogue scale
Description
A vertically oriented 10 cm line was used for VAS, where "no vertigo" corresponds to the bottom of the line and "the worst vertigo that they could imagine" corresponds to the top of the line. Patients were instructed to place a mark on the 10-cm vertical line according to severity of their vertigo.
Time Frame
30 days
Title
Dizziness Handicap Inventory
Description
The DHI has 25 items, sub-grouped into three domains: functional, emotional, and physical. There are three closed-form answers where patients may check one of the following: yes, sometimes and no with the corresponding scored as 4/2/0. It is possible to use both the total score and the scores of the three subscales separately.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients who had unilateral vestibular weakness and persistent dizziness at least two months after acute period were included Bithermal caloric test showing hyporesponsiveness higher than 30% or unresponsiveness of the horizontal canal of the affected ear accepted as unilateral vestibular weakness. Exclusion Criteria: Bilateral vestibular weakness, Recurrent vestibulopathy, Benign paroxysmal positional vertigo, Concomitant neurological or psychiatric disease, Severe visual or auditory impairments and orthopedic problems in the lower extremities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fazıl N Ardıç, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Whole Body Vibration In Vestibular Rehabilitation

We'll reach out to this number within 24 hrs