The effect of cognitive rehabilitation based on information processing speed on balance and mobility in people with Multiple Sclerosis ( MS )
Design
Clinical trial with control group, randomized, single blinded, with 70 patients
Settings and conduct
The intervention group will receive a cognitive rehabilitation program in
Rofeideh Hospital. They will also receive common therapies of occupational therapy that include flexibility and balance exercises. The control group will receive common therapies of occupational therapy that include flexibility and balance exercises in Sina Hospital. Also, the intervention will be explained to all patients, but will not be mentioned the impact of intervention on evaluation tests and mobility and balance.
Participants/Inclusion and exclusion criteria
The person would be willing to participate in the research؛ The person has a definite diagnosis of MS by a specialist؛ The person has an EDSS score of 5 down؛ The person has a FSS score of 9-35؛ The person can work with the camputer؛ The person has no other neurological diseases؛ The person has not taken corticosteroids 28 days before the intervention؛ The person has no psychological disorders.
Intervention groups
The intervention group will receive a cognitive rehabilitation program based on the information processing speed through the Can Tab system for 12 sessions. They will also receive common therapies of occupational therapy that include flexibility and balance exercises.
The control group will receive common therapies of occupational therapy that include include flexibility and balance exercises for 12 sessions.
Main outcome variables
Balance score in the Balance Evaluation System Test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180517039699N1
Registration date:2018-07-08, 1397/04/17
Registration timing:registered_while_recruiting
Last update:2018-07-08, 1397/04/17
Update count:0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Zahra Yaghoobi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 1197
Email address
z.yaghoobi1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-07, 1397/04/16
Expected recruitment end date
2018-11-07, 1397/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive rehabilitation based on information processing speed on occupational performance in people with Multiple Sclerosis (MS)
Public title
The effect of cognitive rehabilitation based on information processing speed on occupational performance in people with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The person would be willing to participate in the research.
The person has a definite diagnosis of MS by a specialist.
The person has an EDSS score of 5 down.
The person has a FSS score of 9-35.
The person can work with the camputer.
The person has no other neurological diseases.
The person has not taken corticosteroids 28 days before the intervention.
The person has no psychological disorders.
The age of the person is 20 to 60 years.
Gender of patients has no limit.
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in two Rofaydeh and Sina centers are randomly divided into control and intervention groups ( refer odd days to Sina hospital for control group and refer even days to Rofaydeh hospital for intervention group). This division was done by draw with cup.
Blinding (investigator's opinion)
Single blinded
Blinding description
َAfter receiving consent from patients, the way of intervention will be explained to them. But the impact of intervention on evaluation tests and mobility and balance will not be mentioned.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Koudakyar dead end, Daneshjou blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۷۱
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.USWR.REC.1396.328
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 score in the Balance Evaluation System Test
Timepoint
The balance will be evaluated before the beginning intervention, after the end of intervention and two months after the end of intervention.
Method of measurement
The Balance Evaluation System Test
Secondary outcomes
1
Description
The information processing speed score in Paced Auditory Serial Addition Test (PASAT)
Timepoint
The information processing speed will be evaluated before the beginning intervention, after the end of intervention and two months after the end of intervention.
Method of measurement
The Paced Auditory Serial Addition Test
2
Description
The information processing speed score in the Symbol Digit Modalities Test (SDMT)
Timepoint
The information processing speed will be evaluated before the beginning intervention, after the end of intervention and two months after the end of intervention.
Method of measurement
The Symbol Digit Modalities Test (SDMT)
Intervention groups
1
Description
Intervention group: The intervention group will receive a cognitive rehabilitation program based on the information processing speed through the Can Tab system for 12 sessions. They will also receive common therapies of occupational therapy that include flexibility and balance exercises.
Category
Rehabilitation
2
Description
Control group: The control group will receive common therapies of occupational therapy that include include flexibility and balance exercises for 12 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofeideh hospital
Full name of responsible person
Fereydoon Layeghi
Street address
Nemati Alley, Soleimani St, Qeytariye
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2220 5326
Fax
+98 21 2223 2741
Email
rofeideh.hospital@uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Amir Massoud Arab Loodaricheh
Street address
Koudakyar dead end, Daneshjou blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0039
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Yaghoobi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 55 , Sadaf Town., Nakhl Ave., Artesh Hwy
City
Tehran
Province
Tehran
Postal code
1955756753
Phone
+98 21 2244 1197
Fax
Email
Z.yaghoobi1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Yaghoobi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 55 , Sadaf Town., Nakhl Ave., Artesh Hwy
City
Tehran
Province
Tehran
Postal code
1955756753
Phone
+98 21 2244 1197
Fax
Email
Z.yaghoobi1993@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Yaghoobi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 55 , Sadaf Town., Nakhl Ave., Artesh Hwy
City
Tehran
Province
Tehran
Postal code
1955756753
Phone
+98 21 2244 1197
Fax
Email
Z.yaghoobi1993@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available