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Completed

NCT Number: NCT03973255

Whole Body Vibration In Vestibular Rehabilitation

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.

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Key information

Conditions

Vestibular Disease Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases Vestibular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation

Behavioral

Posturography, Whole body vibration

Primary outcomes

  1. fall risk

    Time frame: 30 days

    fall risk yielded by static posturography

  2. Berg balance scale

    Time frame: 30 days

    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.

  3. Timed Up-and-Go

    Time frame: 30 days

    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.

  4. vertigo visual analogue scale

    Time frame: 30 days

    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.

  5. Dizziness Handicap Inventory

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Efficacy Of Biofeedback Training And Whole Body Vibration Therapy In Vestibular Rehabilitation Of Unilateral Vestibular Weakness

Acronym: WBV

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2019
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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