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
Comparing the effectiveness of vestibular rehabilitation with and without galvanic vestibular stimulation on dizziness and postural control in patients with persistent postural-perceptual dizziness (PPPD): A randomized controlled trial
Design
Randomized controlled trial with parallel group on 27 patients. Randomization was carried out with Random Allocation Software.
Settings and conduct
Setting: Basra Teaching Hospital
After baseline evaluations including the Modified Clinical Test of Sensory Interaction on Balance, dizziness handicap inventory, and Hospital Anxiety and Depression Scale, each patient will be randomly assigned to three groups VRT, VRT+GVS, and GVS (n= 9 in each group, n=27 total). All patients will be re-evaluated after intervention. The trial is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Diagnosed with persistent perceptual-postural dizziness with 3 months duration or more
2. 18 to 65 years of age
Exclusion criteria:
Catch a disease affecting the vestibular system during the study
Intervention groups
1- VRT group: receiving individualized vestibular rehabilitation 30 minutes twice a day for 6 weeks
2- VRT+GVS group: receiving individualized vestibular rehabilitation 30 minutes twice a day for 6 weeks and at the same time receiving noisy galvanic vestibular stimulation 30 minutes, one session per week for six weeks
3- nGVS group: receiving noisy galvanic vestibular stimulation 30 minutes, one session per week for six weeks
Main outcome variables
Path length (anteroposterior, mediolateral, and angle), dizziness handicap inventory score, and Hospital Anxiety and Depression scale score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160131026279N6
Registration date:2023-09-18, 1402/06/27
Registration timing:registered_while_recruiting
Last update:2023-09-18, 1402/06/27
Update count:0
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Mansoureh Adel Ghahraman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 4364
Email address
madel@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-13, 1402/06/22
Expected recruitment end date
2025-08-13, 1404/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of rehabilitation and galvanic vestibular stimulation on the treatment of persistent postural-perceptual dizziness (PPPD)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Fatigue or unwillingness of the patient to continue the test
Catch a disease affecting the vestibular system during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Approval date
2023-09-03, 1402/06/12
Ethics committee reference number
IR.TUMS.FNM.REC.1402.124
Health conditions studied
1
Description of health condition studied
persistent postural-perceptual dizziness
ICD-10 code
H81.8
ICD-10 code description
Other disorders of vestibular function
Primary outcomes
1
Description
Path length (anteroposterior and mediolateral)
Timepoint
Before and after intervention
Method of measurement
The Modified Clinical Test of Sensory Interaction on Balance
Secondary outcomes
1
Description
Angle of path length
Timepoint
Before and after intervention
Method of measurement
The Modified Clinical Test of Sensory Interaction on Balance
2
Description
Dizziness handicap inventory score
Timepoint
Before and after intervention
Method of measurement
Dizziness handicap inventory
3
Description
Hospital Anxiety and Depression Scale score
Timepoint
Before and after intervention
Method of measurement
Hospital Anxiety and Depression Scale
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
3
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Basra Teaching Hospital
Full name of responsible person
Samer Sami Azeez Al-Saad
Street address
Jaza'er, Abbasiyah
City
Basra
Postal code
42001
Phone
+964 771 806 8604
Email
samiraziz1978@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamid Dalvand
Street address
School of Rehabilitation, Pich-e-hemiran, Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 4364
Email
rehabilitation@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 4364
Fax
+98 21 7753 4133
Email
madel@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 4364
Fax
+98 21 7753 4133
Email
madel@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Adel Ghahraman
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 4364
Fax
+98 21 7753 4133
Email
madel@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
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 the data will become available and for how long
After the study ends and the paper is published for one year at least
To whom data/document is available
Public
Under which criteria data/document could be used
None
From where data/document is obtainable
https://zenodo.org/
What processes are involved for a request to access data/document
Searching the file name or author names in https://zenodo.org/ and downloading the file.