Effects of virtual reality training versus traditional balance training on reaction time, executive function and coordination in people with multiple sclerosis
Effects of virtual reality training versus traditional balance training on reaction time, executive function and coordination in people with multiple sclerosis
Design
A concealed, randomized, double blinded, controlled clinical trial with a parallel group design of 40 patients
Settings and conduct
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: A definite diagnosis of MS, relapsing-remitting or secondary progressive types, as diagnosed by a neurologist; Ability to stand independently; Ages between 18-64 years; Ability to walk independently; Maximum score of 53 on the Berg Balance Scale; MMSE more than 24; EDSS below 5/5
Exclusion criteria: Experiencing an exacerbation of symptoms due to relapse within 3 months of the baseline measurement; Any musculoskeletal or neurological conditions except MS limiting balance or gait; Uncorrected Auditory or visual impairment; Pregnancy; Involving in the other planned treatment; Using drugs which affecting balance or gait.
Intervention groups
Control group: Perform traditional Balance exercises; Participants received 45-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 6 weeks.
Intervention group: Perform Balance exercises using Kinect; Participants received 45-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 6 weeks.
Main outcome variables
Reaction time
Executive function
Coordination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171106037286N2
Registration date:2018-05-11, 1397/02/21
Registration timing:prospective
Last update:2018-05-11, 1397/02/21
Update count:0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
Farshad Molhemi
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3101
Email address
molhemi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of virtual reality training versus traditional balance training on reaction time, executive function and coordination in people with multiple sclerosis
Public title
Effect of two types of exercises on reaction speed and coordination in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: A definite diagnosis of MS, relapsing-remitting or secondary progressive types, as diagnosed by a neurologist; Ability to stand independently; Ages between 18-64 years; Ability to walk independently; Maximum score of 53 on the Berg Balance Scale; MMSE more than 24; EDSS below 5/5 Exclusion criteria: Experiencing an exacerbation of symptoms due to relapse within 3 months of the baseline measurement; Any musculoskeletal or neurological conditions except MS limiting balance or gait; Uncorrected Auditory or visual impairment; Pregnancy; Involving in the other planned treatment; Using drugs which affecting balance or gait.
Exclusion criteria:
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will used in this study. Patients will be matched based on age and gender and then randomized in different groups. A statistical software will use for randomization that will be run by a person who is not a member of research team.
Blinding (investigator's opinion)
Double blinded
Blinding description
Assessments will be performed by a physical therapist who will not inform about grouping. In addition neither the patients nor the analyzer will aware of group assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Science
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.AJUMS.REC.1396.1114
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
Reaction time
Timepoint
Before and after intervention
Method of measurement
Force plate
2
Description
Executive function
Timepoint
Before and after intervention
Method of measurement
Trail making test B-A
3
Description
Coordination
Timepoint
Before and after intervention
Method of measurement
6 spot step test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Perform Balance exercises using Kinect; Participants received 45-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 6 weeks.
Category
Rehabilitation
2
Description
Control group: Perform traditional Balance exercises; Participants received 45-minute individualized (1 trainer to 1 participant) training sessions, 3 times a week for 6 weeks.Categoryrehabilitaion
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Zahra Najarzadeh
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Email
Saeideh.monjezi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohamad Badavi
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3101
Email
saeideh.monjezi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Farshad Molhemi
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Fax
+98 61 3374 3506
Email
molhemi.f@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farshad Molhemi
Position
MSc Student of Physical Therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Fax
Email
f.molhemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farshad Molhemi
Position
MSc Student of Physical Therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3101
Fax
Email
f.molhemi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is not more information
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
All of information will be released in the published article
When the data will become available and for how long
after publishing the article
To whom data/document is available
anyone
Under which criteria data/document could be used
for research purpose
From where data/document is obtainable
to the published article
What processes are involved for a request to access data/document