Protocol summary

Summary
In the research literature the effect of 10-week core stability training were explored on balance and quality of life in female with Multiple Sclerosis with emphasis on Expanded Disability Status Scale (EDSS). There were not found any evidences that study the efficacy of core stability training on movement performance of MS patients. So the aim of this study is to examine the effects of 10-week core stability training on balance (dynamic and static) and quality of life in female with Multiple Sclerosis with emphasis on EDSS. 72 participants are divided in to three groups (2/5≤EDSS<3/5, 3/5≤EDSS<4/5 and 4/5≤EDSS≤5/5). Then, participants are divided into control and experimental subgroups randomly. A pretest and posttest are taken in order to measure balance and Quality of life respectively, Biodex Balance System (BBS) and MSQOL-54. It should be noted that these tests are valid and reliable.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051022194N1
Registration date: 2015-07-24, 1394/05/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Mansour Sahebozamani
Name of organization / entity
Shahid Bahonar University
Country
Iran (Islamic Republic of)
Phone
+98 34 3323 3423
Email address
sahebozamani@mail.uk.ac.ir
Recruitment status
Recruitment complete
Funding source
Neurology Research Center, Kerman University of Medical Sciences; Shahid Bahonar University of Kerman
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of 10-week core stability training on balance and quality of life in female with Multiple Sclerosis with emphasis on Expanded Disability Status Scale.
Public title
The effects of core stability training on balance and quality of life in female with Multiple Sclerosis with emphasis on Expanded Disability Status Scale.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the MS patients confirmed by MS committee of Kerman University of Medical Sciences; EDSS between 2.5 and 5.5; all of them belong to relapsing remitting MS group; age between 23 and 40 years old; new clinical attack during 2 months prior to the study. Exclusion criteria: pregnancy; suffering from other diseases.
Age
From 23 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Neurology Research Center- Kerman University of medcal sciences
Street address
Deputy of Research, Kerman University of medical sciences, Somayeh Cross way, Kerman
City
Kerman
Postal code
7618751151
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
IR.KMU.REC.1394.121

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
static balance
Timepoint
pretest and postest
Method of measurement
Biodex balance system

2

Description
dynamic balance
Timepoint
pretest and postest
Method of measurement
Biodex balance system

3

Description
Quality of life
Timepoint
pretest and postest
Method of measurement
MSQOL-54

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group with 2/5≤EDSS<3/5: core stability training which is done 60 min three days a week during 10 weeks.
Category
Rehabilitation

2

Description
Control group with 2/5≤EDSS<3/5
Category
Rehabilitation

3

Description
Experimental group with 3/5≤EDSS<4/5 : core stability training which is done 60 min three days a week during 10 weeks.
Category
Rehabilitation

4

Description
Control group with 3/5≤EDSS<4/5
Category
Rehabilitation

5

Description
Experimental group with 4/5≤EDSS≤5/5: core stability training which is done 60 min three days a week during 10 weeks.
Category
Rehabilitation

6

Description
Control group with 4/5≤EDSS≤5/5
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology Research Center- Kerman University of Medical Sciences
Full name of responsible person
Hossein Ali Ebrahimi
Street address
Neurology Research Center, Kerman University of Medical Sciences, Kosar Blvd, Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research -Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Deputy of Research, Kerman University of medical sciences, Somayeh Cross way, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research -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 medcal sciences
Full name of responsible person
Behnaz Sedighi
Position
Associate professor
Other areas of specialty/work
Street address
Neurology Research Center, Kerman University of medcal sciences, Blvd. Kosar, Kerman
City
Kerman
Postal code
7618751151
Phone
+98 34 3121 7409
Fax
Email
Behnaz.sedighi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Dr. Mansour Sahebozamani
Position
Associate professor
Other areas of specialty/work
Street address
Department of Sport Injuries and Corrective Exercise, Faculty of Physical Education and Sport Science, Shahid Bahonar University of Kerman
City
Kerman
Postal code
7616914111
Phone
+98 34 3323 3423
Fax
+98 34 3323 3423
Email
sahebozamani@mail.uk.ac.ir; sahebozamani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Banafsheh Amiri
Position
MSc
Other areas of specialty/work
Street address
Department of Sport Injuries and Corrective Exercise, Faculty of Physical Education and Sport Science, Shahid Bahonar University of Kerman
City
Kerman
Postal code
7616914111
Phone
+98 34 3323 3423
Fax
Email
amirib1392@gmail.com
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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