The effect of personalized comprehensive rehabilitation training on static and dynamic balance in women with multiple sclerosis with different disability levels
The purpose of this study is to investigate the effect of personalized comprehensive rehabilitation training on static and dynamic balance in women with multiple sclerosis with different levels of disability. Design and methods of the study: This study is an interventional, single blind clinical trial. In this experimental study, 92 patients admitted to the multiple sclerosis society of Shahrekord city in 2015 were selected and on the basis of disability were categorized into 3 groups mild, moderate and severe. Then each group was randomly divided into experimental and control group. Inclusion criteria: people with Multiple Sclerosis; without experience of regular physical activity in 6 months before beginning of the study; more than two months have passed from the last severity of their illness. Exclusion criteria: patients non-cooperation; death. The personalized comprehensive rehabilitation training program was done 12 weeks, 3 times per week. Then primary outcome including static balance by stand on one leg and dynamic balance by timed up and go test were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016093019995N7
Registration date:2016-11-18, 1395/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
Zahra Mardanpour Shahrekordi
Name of organization / entity
Shahrekord University
Country
Iran (Islamic Republic of)
Phone
+98 38 3232 4401
Email address
banitalebi@lit.sku.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-03-15, 1394/12/25
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of personalized comprehensive rehabilitation training on static and dynamic balance in women with multiple sclerosis with different disability levels
Public title
The effect of personalized comprehensive rehabilitation training
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: people with Multiple Sclerosis; without experience of regular physical activity in 6 months before beginning of the study; more than two months have passed from the last severity of their illness.
Exclusion criteria: patients non-cooperation; death
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
97
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In order to evaluate disability level of patients was used of Expanded Disability Status Scale (EDSS). This scale consists of 10 points which patients according to disease severity to score zero to 10.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of khorasgan
Street address
Islamic Azad University of khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
Isfahan
Postal code
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
23821402932034
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 index
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Stand on one leg test
2
Description
Dynamic balance index
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Timed up and go test
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group: Integrated rehabilitation protocol based on the level of disability that includes 15 minutes of selected training of Pilates, 20 minutes of aerobic training include: treadmill, stationary bike or wheelbarrow, 15 minutes strength training program of upper body and lower body, 10 minutes PNF stretching exercises.
Category
Rehabilitation
2
Description
The control group: do stretching exercises
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple sclerosis society of Shahrekord city
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University of khorasgan
Full name of responsible person
Dr Nader Rahnama
Street address
Islamic Azad University of khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University of khorasgan
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
Islamic Azad University of khorasgan
Full name of responsible person
Dr Nader Rahnama
Position
Dr in sport Injuries and Corrective Exercise
Other areas of specialty/work
Street address
Islamic Azad University of khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
Isfahan
Postal code
Phone
+98 31 3793 2195
Fax
Email
rahnamanader@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of khorasgan
Full name of responsible person
Dr Nader Rahnama
Position
Dr in sport Injuries and Corrective Exercise
Other areas of specialty/work
Street address
Islamic Azad University of khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
Isfahan
Postal code
Phone
+98 31 3793 2195
Fax
Email
rahnamanader@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of khorasgan
Full name of responsible person
Ali Akbar Fazel
Position
MSc, Corrective Exercise
Other areas of specialty/work
Street address
Islamic Azad University of khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
Isfahan
Postal code
Phone
+98 38 3225 2953
Fax
Email
Aliakbarfazel1@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)