Patients in this clinical trial, are suffering from one of two common types of MS, Relapsing-remitting or Secondary progressive, which their diagnosis is based on definite criteria in neurology covered by the MS Society. After obtaining the inclusion criteria, patients' gait and balance in the study, will be evaluated by different methods. Walking speed and stability for 6 meters will be determined. Balance through Romberg test, Berg balance score (Berg Balance test) and the device is evaluated. After division in two groups, exercise and control group will consist of 15 patients in each. Exercise group will be training for 12 weeks, 2 sessions per week and each session includes 20 minutes of balance exercises. After balance training, patients' balance will be evaluated through Romberg test and Berg balance test 6 meter linear system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201094641N5
Registration date:2012-04-27, 1391/02/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-27, 1391/02/08
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical Medicine and Rehabilitation Center, Tabriz University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-09-19, 1391/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Locomotor Trainng and Virtual Reality-based Balance Training in Multiple Sclerosis
Public title
Balance training in multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with one common type of MS (relapsing-remitting or secondary progressive); balance disorder. Exclusion criteria: no history of diabetes; No history of limb trauma; no previous surgery of the upper and lower limbs and joints; Not having myasthenia gravis; No history of myopathy; No history of heart or lung disease or stroke.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for research, Tabriz university of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2011-02-28, 1389/12/09
Ethics committee reference number
9095
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 testing by machine
Timepoint
6 month
Method of measurement
balance training machine
Secondary outcomes
1
Description
walking for 6m-romberg test-berg balance score
Timepoint
6 month
Method of measurement
balance traning machine
Intervention groups
1
Description
exercise group will be training for 12 weeks 2 sessions per week and each session includes 20 minutes of balance exercises.After training, walking speed and stability will be determined for 6 meters.balance will be evaluated by berg balance score and romberg test.patients will be evaluated after 2 month again.
Category
Rehabilitation
2
Description
no interference.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital/Physical Medicine Research Center/MS Society
Full name of responsible person
Dr Bina Eftekhar Sadat
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation, Tabriz University of Medical Sciences
Full name of responsible person
Dr Seyyed Kazem Shakoori
Street address
Physical Medicine and Rehabilitation centre, Imam reza hospital, The golgasht street, Azadi avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation, Tabriz University of Medical Sciences
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
Tabriz university of medical sciences
Full name of responsible person
Elnaz Azari
Position
Intern
Other areas of specialty/work
Street address
Tabriz university of medical science, Golgasht street, Azadi avenue
City
Tabriz
Postal code
5166616471
Phone
+98 41 1337 6923
Fax
Email
elnaz.azari@gmail.com , elnaz.azary@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physical Medicine and Rehabilitation Center, Imam reza hospital
Full name of responsible person
Dr Bina Eftekhar Sadat
Position
Associate Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Center, Imam reza hospital, The Golgasht street, Azadi avenue
City
Tabriz
Postal code
Phone
+98 41 1385 7765
Fax
Email
binasadat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Elnaz Azari
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)