The effect of combined rehabilitation based on visuo-perceptual and galvanic vestibular stimulation on balance function and brain waves of patients with right hemisphere ischemic stroke
Assessing the effect of combined rehabilitation based on visuo-perceptual and galvanic vestibular stimulation on balance function and brain waves in patients with right hemisphere ischemic stroke
Design
A controlled clinical trial with parallel groups, randomized using hexagonal block on 45 stroke patients
Settings and conduct
Patients with right hemisphere stroke with an individual complaint of imbalance in Rofideh Rehabilitation Hospital undergo vertical vision perception (SVV), status and electroencephalography assessments.
Then they are divided into different groups and undergo galvanic atrial rehabilitation and RCDM for 10 sessions.
At the end of the rehabilitation period and one month later, the evaluations are repeated.
Participants/Inclusion and exclusion criteria
Age range 40 to 60 years;
Having a stroke for the first time in a year;
No peripheral vestibular disorders;
Difficulty balancing and walking;
Ability to stand without assistance for at least 30 seconds;
Right-handed.
Intervention groups
Group A (control): Stroke patients receiving conventional rehabilitation.
Group B (intervention): Stroke patients receiving RCDM and sham galvanic rehabilitation.
Group C (intervention): Stroke patients receiving combined galvanic and RCDM rehabilitation.
Main outcome variables
Changing the vertical perception of vision, Change the balance, Altered brain activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201116049417N1
Registration date:2020-12-25, 1399/10/05
Registration timing:registered_while_recruiting
Last update:2020-12-25, 1399/10/05
Update count:0
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
Meymaneh Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2295 6308
Email address
m.jafari@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined rehabilitation based on visuo-perceptual and galvanic vestibular stimulation on balance function and brain waves of patients with right hemisphere ischemic stroke
Public title
The combined rehabilitation at cerebral stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ischemic stroke for the first time
Confirmation of right hemisphere stroke with clinical evaluation and MRI imaging
Having a stroke more than 2 weeks and less than a year before the start of the study
Ability to understand oral commands
Awareness of self, place and time
Difficulty in balance and walking
Stable medical condition
Ability to stand independently without assistance for at least 30 seconds
Ability to walk with or without aid for at least 15 meters
Good visual acuity with proper correction
Right-handed
Appropriate cognitive status and earning a minimum of 19 points using MMSE
Exclusion criteria:
Cerebellar and orthopedic injuries
Existence of neurological problems other than stroke
The difference in the length of the two legs is more than 2 cm
Use of drugs that impair vestibular function
Peripheral vestibular disorders confirmed by VNG, vHIT and VEMP assessments
History of BPPV
Use of a heart pacemaker, metal brain implants, epilepsy or skin allergies behind the corners
Recurrent strokes
Any uncontrolled health condition in which assessments are prohibited
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method was used for random allocation. The statistician designs 8 blocks of 6 (considering that we have 3 groups) using the "sealedenvelope.com" website. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. The sample allocation ratio will be (Allocation 1: 1) and fall into three groups. Rehabilitation exercises will then be given to patients based on the obtained blocks and in the order of allocation sequence.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave., Daneshjo Blvd., Evin (Velenjak)
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2019-10-21, 1398/07/29
Ethics committee reference number
IR.USWR.REC.1398.118
Health conditions studied
1
Description of health condition studied
Right hemisphere ischemic stroke
ICD-10 code
I61.1
ICD-10 code description
Nontraumatic intracerebral hemorrhage in hemisphere, cortical
Primary outcomes
1
Description
Score of Balance Systems Assessment Questionnaire (BESTest)
Timepoint
Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation
Method of measurement
Using the BESTest questionnaire
2
Description
Score of POMA Balance and Gait Evaluation Questionnaire
Timepoint
Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation
Method of measurement
Using the POMA questionnaire
3
Description
LOS range of motion
Timepoint
Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation
Method of measurement
Using posturography
4
Description
SOT composite score
Timepoint
Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation
Method of measurement
Using posturography
5
Description
Fixed error and absolute error of vertical vision perception (SVV)
Timepoint
Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation
Method of measurement
Using SVV test
6
Description
DTABR and BSI in electroencephalography
Timepoint
Before starting rehabilitation, Immediately after completion of rehabilitation, One month after the end of rehabilitation
Method of measurement
Using Electroencephalography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sham vestibular galvanic stimulation for 20 minutes (providing stimulation at the beginning and turning off the stimulus), 2- Performing RCDM rehabilitation (perpendicularity of the line in the optokinetic field of view) for 20 minutes. This process is repeated during 20 sessions.Community Verified icon
Category
Rehabilitation
2
Description
Intervention group: 1- Presenting galvanic vestibular stimulation for 20 minutes at the threshold level and 2- Performing RCDM (perpendicular line in the optokinetic field of view) rehabilitation for 20 minutes. This process is repeated during 20 sessions.
Category
Rehabilitation
3
Description
Control group: Stroke patients receiving conventional physiotherapy rehabilitation: According to studies, range of motion exercises related to the upper and lower limbs, weight lifting on the involved side, walking in parallel load forward and backward, pelvic bridging exercises and stretching exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rifeideh rehabilitation hospital
Full name of responsible person
Dr. Saeideh Mehrkian
Street address
Nemati Aly, South Salimi Ave. Andarzgou Blv.
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2220 5326
Email
rofeideh.hospital@uswr.ac.ir
Web page address
http://rofeideh.uswr.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Hamidreza KhorramKhorshid
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2832
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Meymaneh Jafari
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Third Fl., No. 2, Khosrobeigi Aly., Mojdeh St. Hoseinabad Sq., HeraviSq.
City
Tehran
Province
Tehran
Postal code
1668844844
Phone
+98 21 2295 6308
Email
meymaneh.jafari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
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
Yes - There is 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
All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
The data of this study will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Further analysis of the delivered data will be possible only with the coordination of the main researcher.
From where data/document is obtainable
Applicants can submit their application by sending an email to the lead researcher.
What processes are involved for a request to access data/document
The request is first submitted to the principal investigator. The data is then sent to the applicant in coordination with other research colleagues and in determining the applicant's purpose.