Condition or disease | Intervention/treatment | Phase |
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Vestibular Disease | Behavioral: Rehabilitation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy Of Biofeedback Training And Whole Body Vibration Therapy In Vestibular Rehabilitation Of Unilateral Vestibular Weakness |
Actual Study Start Date : | March 13, 2018 |
Actual Primary Completion Date : | January 31, 2019 |
Actual Study Completion Date : | March 31, 2019 |
Arm | Intervention/treatment |
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Placebo Comparator: Home based vestibular rehabilitation program
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.
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Behavioral: Rehabilitation
Posturography, Whole body vibration
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Active Comparator: Biofeedback training
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.
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Behavioral: Rehabilitation
Posturography, Whole body vibration
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Active Comparator: Whole body vibration
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.
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Behavioral: Rehabilitation
Posturography, Whole body vibration
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
Turkey | |
Pamukkale University | |
Denizli, Turkey, 20070 |
Principal Investigator: | Fazıl N Ardıç, MD | Pamukkale University |
Tracking Information | |||||
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First Submitted Date ICMJE | June 1, 2019 | ||||
First Posted Date ICMJE | June 4, 2019 | ||||
Last Update Posted Date | June 5, 2019 | ||||
Actual Study Start Date ICMJE | March 13, 2018 | ||||
Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Whole Body Vibration In Vestibular Rehabilitation | ||||
Official Title ICMJE | Efficacy Of Biofeedback Training And Whole Body Vibration Therapy In Vestibular Rehabilitation Of Unilateral Vestibular Weakness | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Vestibular Disease | ||||
Intervention ICMJE | Behavioral: Rehabilitation
Posturography, Whole body vibration
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
90 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 31, 2019 | ||||
Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
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 |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Turkey | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03973255 | ||||
Other Study ID Numbers ICMJE | 1 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Fazıl Necdet Ardıç, Pamukkale University | ||||
Study Sponsor ICMJE | Pamukkale University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pamukkale University | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |