Protocol summary

Summary
In the research literature the effect of dual tasks were explored on postural control and balance in subjects such as old aged people and cases with stroke. Although persons with Multiple Sclerosis (MS) commonly have walking and balance control impairments, there were not found any evidences that study the efficacy of dual task on movement performance of MS patients. So the aim of the study is to examine the effect of dual task intervention (movementـcognitive) on dynamic and static balance, functional mobility and walking speed in women with MS. 36 participants (expanded disability status scale: 3-7) are divided randomly in to three groups (control, single task and dual task). A pre test and post test are taken in order to measure balance, functional mobility and walking speed via, respectively, BIODEX, Up and Go walking test and 25 feet walking test. It should be noted that these tests are valid and reliable.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201408188436N2
Registration date: 2014-09-07, 1393/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-07, 1393/06/16
Registrant information
Name
Hossein Ali Ebrahimi
Name of organization / entity
Neurology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 34 1246 7500
Email address
hebrahimi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Neurology Research Center - Kerman University of medical sciences
Expected recruitment start date
2014-08-18, 1393/05/27
Expected recruitment end date
2015-08-18, 1394/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of dual task versus single task training on balance and functional mobility in patient with multiple sclerosis
Public title
Efficacy of dual task on multiple sclerosis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: the MS patients confirmed by MS committee of Kerman University of Medical Sciences; the EDSS between 3-7; cooperation of MS patients. Exclusion criteria: combined with other disease; the demographic and position criteria of three groups should be same.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
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
Ethic committee of Deputy of Research
Street address
Jahad Blvd - Ebne Sina Avenue - Kerman - Iran
City
Kerman
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
کا/93/42

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
dynamic balance
Timepoint
rate of deviation(0-10)
Method of measurement
by Biodex instrument

2

Description
functional mobility 25 foot walking
Timepoint
timed 25 foot walking (seconds)
Method of measurement
time measurment

3

Description
up and go duratin
Timepoint
duration (seconds)
Method of measurement
time measurment

Secondary outcomes

empty

Intervention groups

1

Description
In the present study intervention protocol involve a variety of balance tasks which is done 45 min three days a week during one month. The patients are 15-18 cases
Category
Rehabilitation

2

Description
In the present study intervention protocol involve a variety of balance tasks which is done 45 min three days a week during one month. These tasks are done along with a cognitive task as dual task condition. The patients are 15-18 cases.
Category
Rehabilitation

3

Description
in this present stdy the contrl group is (18-15) patients (MS) that age and EDSS are same with intervention group, but balanced task has not done, only functional mobility and dynamic balance tests evaluated at first and after one month.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology Research Center- Kerman University of medcal sciences
Full name of responsible person
Hossein Ali Ebrahimi M.D
Street address
Kosar Blvd
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neurology Research Center - Kerman University of medical sciences
Full name of responsible person
Gholam Reza Sepehri M.D
Street address
Somayeh Cross way - Deputy of Research -Kerman University of medical sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neurology Research Center - Kerman 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
Neurology research center, Kerman University of medical sciences
Full name of responsible person
Hossein Ali Ebrahimi
Position
Professor
Other areas of specialty/work
Street address
No.14, 3rd Sharghi, 17 alley, Parvin Etesami Avenue
City
Kerman
Postal code
76136 93685
Phone
+98 34 1246 7500
Fax
Email
hebrahimi@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Physical Education and Sports Sciences, Shahid Bahonar University
Full name of responsible person
Mahshid Zare Zade
Position
Assistant professor
Other areas of specialty/work
Street address
Faculty of Physical Education and Sports Science, Shahid Bahonar University
City
Kerman
Postal code
Phone
+98 34 1244 1615
Fax
Email
zarezade.mahshid@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Bahonar University
Full name of responsible person
Farnaz Saeed
Position
MSc
Other areas of specialty/work
Street address
Shahid Bahonar University
City
Kerman
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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