The main purpose of this study was to improve patients' cognitive and motor function using dual tasks.
Design
A clinical trial consisting of 3 intervention groups and a control group, with parallel, on 60 patients.
Settings and conduct
The participants of this study were patients of MS in Tehran province. Using G-Power software with test power of 0.8, the effect size of 0.8 and an error level of 0.05, the sample size of 60 people was determined. Out of 78 participants, 60 were selected as eligible for the study. And were divided into 4 groups by the examiner. All stages of the research were held in the training hall of Tehran MS Association.
Participants/Inclusion and exclusion criteria
Low to moderate disability, no replace in recent months, no physical, mental, and emotional problems, no addiction
Intervention groups
Group (1) dual cognitive-motor tasks; Group (2) dual motor-motor tasks; Individual groups (3) who only did walking exercises and (4) controls who went about their daily lives.
Main outcome variables
the balance; walking; Speed and accuracy of information processing; Quality of Life; Depressive Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200812048384N1
Registration date:2020-08-26, 1399/06/05
Registration timing:retrospective
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Arash Abasnia
Name of organization / entity
The university of tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 5678 5366
Email address
arash.abasnia@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-07-30, 1398/05/08
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2019-08-04, 1398/05/13
Trial completion date
2019-11-09, 1398/08/18
Scientific title
Comparison of the effectiveness of dual tasks cognitive-motor and motor-motor on cognitive and motor function in patients with multiple sclerosis
Public title
"The effect of dual-task training on cognitive and motor rehabilitation of MS patients"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having an Expanded Disability Status Scale (EDSS) 2-5
Age range 20-50
Do not use assistive devices for walking
No dementia
Ability to walk 10 meters without assistance
At least a diploma
30 days have passed since the last relapse of the patient
Exclusion criteria:
Addiction to drugs or alcohol
Having a motor defect in the limbs
History of heart attack or stroke
Having psychological problems
Participate in another study
Do not participate in sports classes such as yoga, Pilates, etc
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Physical Education and Sports Sciences - University of Tehran
Street address
Second floor., No. 180, Darvish St., Hosseini St., Qazvin St
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۹۳۵۸۴۰
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.UT.SPORT.REC.1398.049
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance
Timepoint
Measurement of balance tests before and after 8 weeks of intervention
Method of measurement
Special functional tests of balance
2
Description
Walking
Timepoint
Measurement of walking tests before and after 8 weeks of intervention
Method of measurement
Timed up and go
3
Description
Information processing speed
Timepoint
Measurement of information processing speed tests before and after 8 weeks of intervention
Method of measurement
Stroop online test
4
Description
Accuracy of information processing
Timepoint
Measurement of information processing Accuracy tests before and after 8 weeks of intervention
Method of measurement
Stroop online test
5
Description
Quality of Life
Timepoint
Measurement of information before and after 8 weeks of intervention
Method of measurement
MSIS-29 questionnaire
6
Description
Depressive Anxiety
Timepoint
Measurement of information before and after 8 weeks of intervention
Method of measurement
Hospital Anxiety Depression Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cognitive-motor group for two months, 2 days a week and 45-60 minutes. Double cognitive-motor tasks with one cognitive task (such as counting backwards) and one motor task (such as walking over an obstacle) Did.
Category
Rehabilitation
2
Description
Intervention group 2: The motor-motor group practiced dual motor-motor tasks (such as walking and wearing a warm-up) for two months, 2 days a week and 45-60 minutes.
Category
Rehabilitation
3
Description
Intervention group 3: Individual homework group practiced walking for 2 months, 2 days a week and 45-60 minutes of different exercises.
Category
Rehabilitation
4
Description
Control group: The control group did not have any exercise during the eight weeks of training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran MS Society
Full name of responsible person
Dr. Mousavi
Street address
No. 35, Mohammad Shams Alley, Vesal Shirazi St., Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
1416864731
Phone
+98 21 6695 1187
Fax
+98 21 6649 9514
Email
info@iranms.ir
Web page address
http://www.iranms.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Mehdi Shahbazi
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1417935840
Phone
+98 21 8835 1730
Fax
+98 21 8802 1527
Email
infosport@ut.ac.ir
Web page address
http://sport.ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Physical Education, University of Tehran
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Arash Abasnia
Position
Senior students
Latest degree
Master
Other areas of specialty/work
Others
Street address
Second floor., No. 180, Darvish St., Hosseini St., Qazvin St
City
Tehran
Province
Tehran
Postal code
1357847761
Phone
+98 21 5678 5366
Email
abasiarash09@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Arash Abasnia
Position
Senior students
Latest degree
Master
Other areas of specialty/work
Others
Street address
Second floor., No. 180, Darvish St., Hosseini St., Qazvin St
City
Tehran
Province
Tehran
Postal code
1357847761
Phone
+98 21 5678 5366
Email
abasiarash09@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Arash Abasnia
Position
Senior students
Latest degree
Master
Other areas of specialty/work
Others
Street address
Second floor., No. 180, Darvish St., Hosseini St., Qazvin St
City
Tehran
Province
Tehran
Postal code
1357847761
Phone
+98 21 5678 5366
Email
abasiarash09@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data of the measured variables can be shared after identifying individuals
When the data will become available and for how long
Start of access period from 2020
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Scientific use is permitted in improvement and comparison with other research
From where data/document is obtainable
Email address for correspondence
What processes are involved for a request to access data/document
The applicant must send the reason for using the documents by e-mail