Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders
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|ClinicalTrials.gov Identifier: NCT04010435|
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vestibular Disorders||Device: repetitive transcranial magnetic stimulation Device: Galvanic stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||May 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Active Comparator: Group A (r TMS group)
Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises.
Device: repetitive transcranial magnetic stimulation
high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.
Active Comparator: Group B (Galvanic stimulation)
Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo galvanic vestibular stimulation; in addition to designed vestibular rehabilitation exercises.
Device: Galvanic stimulation
galvanic stimulation of the vestibular apparatus
No Intervention: Control (Group C)
Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises.
- Vestibular canal weakness [ Time Frame: 1 mounth ]Videonystagmography- Scores ranging zero min score and 100 max score
- Dizziness handicapped inventory [ Time Frame: 1 month ]identify difficulties that you may be experiencing because of your dizziness- 25 items with max score 100 and min score zero
- Postural stability [ Time Frame: 1 month ]Computerized dynamic Posturography- Scores ranging zero min score and 100 max score
- Balance [ Time Frame: 1 month ]Berg balance scale - 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56
- Vestibular disorders activities of daily living [ Time Frame: 1 month ]The Vestibular Disorders Activities of Daily Living (VADL) scale assesses the impact of vestibular impairment on everyday activities. The 28 items are grouped into three dimensions: functional (self-care and intimate activities), ambulation (walking and stair climbing), and instrumental (home management and leisure activities).Each item is rated with zero (min score) to 10 (max score)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010435
|Contact: Reham A.M. Ahmed, Phdemail@example.com|
|Contact: Hesham M. S. Nafia, M.Scfirstname.lastname@example.org|
|Cairo, Giza, Egypt, 12613|
|Contact: Reham A.M. Ahmed, phd 00201285059796 email@example.com|