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IRCT20160131026279N6 IRCT 2023-09-18 Tehran University of Medical Sciences The effect of rehabilitation and galvanic vestibular stimulation on the treatment of persistent postural-perceptual dizziness (PPPD) Comparing the effectiveness of vestibular rehabilitation with and without galvanic vestibular stimulation on dizziness and postural control in patients with persistent postural-perceptual dizziness: A randomized controlled trial 2023-09-13 anticipated 27 Complete https://irct.ir/trial/72572 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Method of randomization: block Unit of randomization: size 3, three equal groups Tools used in randomization: Random allocation software Random sequence generation: Random allocation software Allocation concealment: none Patients will be allocated to groups indicated in the sequence in order of enrolling in the study. For example, in a sequence of group 3, group 1, and group 2, the first patient will be allocated to group 3, and so on. N/A persistent postural-perceptual dizziness. Intervention 1: Intervention group 1 (VRT): receiving individualized vestibular rehabilitation 30 minutes twice a day for 6 weeks, in which the rehabilitation exercises are planned based on the patient's complaints and test results. Exercises include adaptation, gaze stabilization, and habituations which involve eye, head, and body movements. Intervention 2: Intervention group 2 (VRT+GVS): receiving individualized vestibular rehabilitation 30 minutes twice a day for 6 weeks and noisy GVS 30 minutes, one session per week for six weeks, in which the rehabilitation exercises are planned based on the patient's complaints and test results. Exercises include adaptation, gaze stabilization, and habituations which involve eye, head, and body movements. The electrical stimulation (random bandwidth of less than 30 Hz, bipolar current, and sub-threshold intensity) is applied through electrodes placed over mastoid processes. Intervention 3: Intervention group 3 (nGVS): receiving noisy GVS 30 minutes, one session per week for six weeks, in which the electrical stimulation (random bandwidth of less than 30 Hz, bipolar current, and sub-threshold intensity) is applied through electrodes placed over mastoid processes. Yes - There is a plan to make this available What will be shared: Data files containing all data will be uploaded via https://zenodo.org/ after the deidentification of participants, named "Dataset of Comparing the effectiveness of vestibular rehabilitation with and without galvanic vestibular stimulation on dizziness and postural control in patients with persistent postural-perceptual dizziness: A randomized controlled trial" When: After the study ends and the paper is published for one year at least To whom: Public Conditions: None Where to obtain: https://zenodo.org/ How to obtain: Searching the file name or author names in https://zenodo.org/ and downloading the file. Comments:
public Mansoureh Adel Ghahraman
Enghelab Ave.
Tehran Iran (Islamic Republic of) 6511111489 +98 21 7753 4364 madel@tums.ac.ir Tehran University of Medical Sciences scientific Mansoureh Adel Ghahraman
Enghelab Ave.
Tehran Iran (Islamic Republic of) 6511111489 +98 21 7753 4364 madel@tums.ac.ir Tehran University of Medical Sciences Iraq Diagnosed with PPPD according to Barany Society Committee diagnostic criteria. The symptoms of 3 months duration or more No previous experience with vestibular exercises or rehabilitation 18 to 65 years of age Lack of previous drug or alcohol addiction No Current neurological disorder Lack of drug consumption that results in suppressing vestibular system compensation Not pregnant woman No current vestibular disease coexist with PPPD patients Lack of musculoskeletal issues that impair gait Absence of cognitive impairment No vestibular paroxysmia 18 years 65 years Both Fatigue or unwillingness of the patient to continue the test Catch a disease affecting the vestibular system during the study H81.8 Other disorders of vestibular function Rehabilitation Rehabilitation Rehabilitation Intervention group 1 (VRT): receiving individualized vestibular rehabilitation 30 minutes twice a day for 6 weeks, in which the rehabilitation exercises are planned based on the patient's complaints and test results. Exercises include adaptation, gaze stabilization, and habituations which involve eye, head, and body movements. Intervention group 2 (VRT+GVS): receiving individualized vestibular rehabilitation 30 minutes twice a day for 6 weeks and noisy GVS 30 minutes, one session per week for six weeks, in which the rehabilitation exercises are planned based on the patient's complaints and test results. Exercises include adaptation, gaze stabilization, and habituations which involve eye, head, and body movements. The electrical stimulation (random bandwidth of less than 30 Hz, bipolar current, and sub-threshold intensity) is applied through electrodes placed over mastoid processes. Intervention group 3 (nGVS): receiving noisy GVS 30 minutes, one session per week for six weeks, in which the electrical stimulation (random bandwidth of less than 30 Hz, bipolar current, and sub-threshold intensity) is applied through electrodes placed over mastoid processes. Path length (anteroposterior and mediolateral). Timepoint: Before and after intervention. Method of measurement: The Modified Clinical Test of Sensory Interaction on Balance. Angle of path length. Timepoint: Before and after intervention. Method of measurement: The Modified Clinical Test of Sensory Interaction on Balance. Dizziness handicap inventory score. Timepoint: Before and after intervention. Method of measurement: Dizziness handicap inventory. Hospital Anxiety and Depression Scale score. Timepoint: Before and after intervention. Method of measurement: Hospital Anxiety and Depression Scale. Tehran University of Medical Sciences Approved 2023-09-03 School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences Enghelab Ave. Tehran Tehran Iran (Islamic Republic of)