Effectiveness of transcranial direct current stimulation with virtual reality training for balance and fear of falling in people with multiple sclerosis, a randomized control trial
Determining the effectiveness of tDCS stimulation with virtual reality on the postural stability of people with multiple sclerosis.
Design
This clinical trial has three intervention groups, sham and control, with parallel, single-blind, and randomized groups, on 36 patients. In this study, simple random method is used
Settings and conduct
This study will be conducted at Semnan Neuromuscular Rehabilitation Research Center.
In this study, the evaluator does not know the allocation of groups
All three groups receive virtual reality training along with tDCS. In one group, tDCS is on and in another group, tDCS is off, and one group receives only virtual reality interventions. The intervention will be implemented for two weeks and 5 days a week
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-60-year-old people with multiple sclerosis who have mild to moderate disability and have a cognitive score higher than 21 in the MMSE test and have no history of falling in the past month.
Exclusion criteria: If the participants do not have neurological and orthopedic disorders that affect the performance of the tests and do not have a history of using corticosteroids up to 28 days before the evaluation, based on the medical records and the patient's statements. Also, he does not have any mental problems, attacks or relapses during the last 2 months.
Intervention groups
1- Virtual Reality (VR) exercises with active tDCS on the cerebellum area
2- VR intervention along with tDCS sham on the cerebellum
3- VR intervention
Main outcome variables
Balance performance; Fear of falling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150411021686N4
Registration date:2023-12-01, 1402/09/10
Registration timing:prospective
Last update:2023-12-01, 1402/09/10
Update count:0
Registration date
2023-12-01, 1402/09/10
Registrant information
Name
Zahra Ahmadizadeh
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
ahmadizadeh.z@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of transcranial direct current stimulation with virtual reality training for balance and fear of falling in people with multiple sclerosis, a randomized control trial
Public title
The effect of electrical stimulation of the brain with virtual reality on people with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having MS as diagnosed by a neurologist
No history of falling in the last month according to the reference or family report
No addiction according to the client's, family or doctor's report
Not having obvious orthopedic, rheumatology, or internal problems that the person complains about (such as back pain, hallux valgus, flat feet, foot ulcers) according to the client's report, the family or the client's doctor, if you cause problems in the implementation of the tests
People with mild to moderate disability EDSS=1-5
Age range 18-60 years
having cognitive impairment (getting a score higher than 21 in the MMSE test)
Exclusion criteria:
Corticosteroid use up to 28 days before evaluation based on medical records and patient statements
Having mental problems (according to the patient's file)
Having a history of attacks and relapses in the last 2 months (according to the patient's file)
Having a history of other neurological diseases (according to the patient's file)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, patients who meet the inclusion criteria are included in the study. Therefore, our sampling method is convenience sampling at this stage of the method. The randomization method in this research is a web-based block randomization, due to having three groups, blocks of 3 and 6 will be used, and the order of the blocks will be obtained using random numbers on the web, so it can be 36 The participant was randomly assigned to the study. Participants are placed in three control, sham and intervention groups based on the order of entry. The assessor will not know about the random allocation and group allocation of the participants in any of the assessment stages. The number of blocks and how they are executed is done by hiding them inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
A single-blind , the assessor will be blind to group allocation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
5 km Damghan Road, school of Rehabilitation
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.SEMUMS.REC.1402.168
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Balance
Timepoint
before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention
Method of measurement
Biodex
2
Description
fear of falling
Timepoint
before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention
Method of measurement
Fear of falling questionnaire
Secondary outcomes
1
Description
Fatigue
Timepoint
Before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention
Method of measurement
Fatigue Severity Scale questionnaire
2
Description
Activity of daily living
Timepoint
Before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention
Method of measurement
Lawton questionnaire
3
Description
Postural control
Timepoint
Before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention
Method of measurement
Force Plate
4
Description
Functional mobility
Timepoint
Before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention
Method of measurement
Time Up & Go test
Intervention groups
1
Description
Intervention group: receiving virtual reality balance exercises with bright tDCS. To use tDCS, a direct stimulation current will be used by a pair of electrodes (cathode and anode). The current is controlled by an ammeter. Stimulation electrodes are 7x5 cm in size. When using TDCS, a current of 2 mA is applied to the cerebellum for a maximum of 20 minutes. Virtual reality device Visual cues are created by a virtual reality device. A closed loop device is installed on the head. , provides the patient with a virtual tiled floor in a checkerboard arrangement, which dynamically responds to the patient's own movement, much like a real floor, fixed in space.
Category
Rehabilitation
2
Description
Sham control group: received virtual reality balance exercises with tDCS off. This group receives only virtual reality treatment and the silent tDCS device is used for them
Category
Other
3
Description
Control group: Receive only virtual reality balance exercises
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Zahra Ahmadizadeh
Street address
Quds Boulevard - next to Nemat Ice Cream - Tabatabai Clinic
City
Semnan
Province
Semnan
Postal code
35196-98375
Phone
+98 23 3332 8502
Email
nmrrc@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Majid Mirmohammadkhani
Street address
Basij Blvd., Central Headquarters of Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Zahra Ahmadizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Damghan Road - Semnan Medical Sciences Campus - Faculty of Rehabilitation
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ahmadizade.z@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Zahra Ahmadizadeh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Semnan-Kilometer 5 Damghan Road-Semnan Medical Sciences school of Rehabilitation
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
ahmadizade.z@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Ahmadizadeh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Semnan-Kilometer 5 Damghan Road-Semnan Medical Sciences, school of Rehabilitation
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ahmadizade.z@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data of this study will be available for meta-analysis
From where data/document is obtainable
Zahra Ahmadizadeh, Mashahir Square, Quds Boulevard, Neuromuscular Rehabilitation Research Center Phone: 00982333654180 Postal Code: 3513138111
ahmadizade.z@gmail.com
What processes are involved for a request to access data/document
In order to request the data of this study, it is necessary to send an official written request by e-mail and clearly explain the reason for the request.