The purpose of this double-blinded, randomized controlled trial study is to compare the effect of virtual reality training versus traditional balance training on balance and fall risk in people with multiple sclerosis. Inclusion criterias include: ability to stand and walk independently, maximum score of 53 on BBS, EDSS below 5/5 and MMSE more than 24. Persons are ineligible for the study if they have an exacerbation of symptoms due to relapse within 3 months of the baseline measurement and any musculoskeletal or neurological conditions except MS limiting balance or gait. Forty patients with MS will be assigned randomly in virtual reality training or traditional balance training (control) group. Participants will receive 45 minutes training session, 3 times per week for 6 weeks. The participants in the traditional balance training group will receive common balance activities while participants in virtual reality training group will practice balance activities using Kinect. Outcome measures for assessing Various aspects of balance and risk of fall are force plate, Timed Up and Go, 10 meter Walk gait speed, Berg Balance Scale, Activities Specific Balance Confidence and Fall Efficacy Scale International. All measures will be collected at baseline and at the end of training.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017110737286N1
Registration date:2017-11-17, 1396/08/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-17, 1396/08/26
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
Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-12-06, 1397/09/15
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 balance and fall risk in people with multiple sclerosis
Public title
Effect of two types of exercises on balance performance in patients with multiple sclerosis
Purpose
Treatment
Inclusion/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.
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Postal code
6135715794
Approval date
2017-10-28, 1396/08/06
Ethics committee reference number
IR.AJUMS.REC.1396.558
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
Static balance
Timepoint
Before and after intervention
Method of measurement
Force plate
2
Description
Dynamic balance
Timepoint
Before and after intervention
Method of measurement
Time Up and Go Test, 10 meter walk test
3
Description
Functional balance
Timepoint
Before and after intervention
Method of measurement
Berg balance scale
4
Description
Balance Confidence
Timepoint
Before and after intervention
Method of measurement
Activities Specific Balance Confidence
5
Description
Fear of falling
Timepoint
Before and after intervention
Method of measurement
Fall efficacy scale international
Secondary outcomes
empty
Intervention groups
1
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.
Category
Rehabilitation
2
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
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Mohamad Badvi
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Farshad Molhemi
Position
MSc Student of Physical Therapy
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3374 3101
Fax
Email
f.molhemi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Farshad Molhemi
Position
MSc Student of Physical Therapy
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3374 3101
Fax
Email
f.molhemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ah
Full name of responsible person
Farshad Molhemi
Position
MSc Student of Physical Therapy
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)