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Effectiveness of Cognitive rehabilitation on cognitive status (attention, memory, executive function) and quality of life in patients with multiple sclerosis: A randomized control clinical trial.

Protocol summary

Summary
Objectives: This study has been designed to evaluate the effect of cognitive rehabilitation on memory, attention, executive function and quality of life in patients with multiple sclerosis. Design: The present study is a randomized clinical trial with control group, a cross sectional study. Setting and conduct: The patients who live in Shiraz, suffering from multiple sclerosis and are referred to Imam Reza medical clinic and some private clinics will be selected. They will be evaluated and then divided into two groups, randomly. Participants including major eligibility criteria: 30 patients who meet the inclusion criteria; age between 18 to 45 years, relapsing- remitting MS and be educated more than 6 grades will be selected and the ones with other psychiatric or medical disorders, major motor deficit, pregnant and those who had any attack during the previous 6 months will be excluded from the study. Intervention: All the patients will take pre-test exams then they are divided into two groups (control and intervention).the intervention group will participate 8 sessions of cognitive rehabilitation in 2 weeks. Both groups will be tested the same exams again (just after group therapy is finished and then 3 months later). Data collecting methods are: Demographic Questionnaire, Right/Left Dominance Questionnaire, ACE-R Questionnaire, CPT/WSCT Tests, Psychiatric interview, CFQ executive function test, DASS test. Main outcome variables: The cognitive status (attention, memory, executive function) of the patients and their quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016090929714N1
Registration date: 2016-12-18, 1395/09/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-18, 1395/09/28
Registrant information
Name
Elnaz Chohedri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
echohedri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive rehabilitation on cognitive status (attention, memory, executive function) and quality of life in patients with multiple sclerosis: A randomized control clinical trial.
Public title
Effectiveness of Cognitive Rehabilitation in Multiple Sclerosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- At least 6 grade of school education; 2- Age between 18 to 45 years old; 3- Relapsing-Remitting multiple sclerosis; 4- Right dominance Exclusion criteria: 1- Multiple sclerosis attack in the recent 6 months; 2- Left dominance or ambidexterity; 3- Patients unwilling to participate in the survey; 4- Psychiatric debilitating illness; 5- Chronic psychiatric disease; 6- No motor deficit; 7- Pregnancy
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
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
ٍEthic comittee of Shiraz University of Medical Sciences
Street address
Ethic Comittee, 7th floor, Medical School, Zand St.
City
Shiraz
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
ir.sums.med.rec.1394.74

Health conditions studied

1

Description of health condition studied
Dementia in other specified diseases classified elsewher
ICD-10 code
F02.8
ICD-10 code description
Dementia (in): cerebral lipidosis, epilepsy, hepatolenticular degeneration, hypercalcaemia, hypothyroidism, acquired, intoxications, multiple sclerosis, neurosyphilis, niacin deficiency, polyarteritis nodosa, systemic lupus erythematosus, trypanosomiasis

Primary outcomes

1

Description
memory
Timepoint
before intervention- immediately after intervention- 3 months after intervention
Method of measurement
ACE-R test

2

Description
Executive function
Timepoint
before intervention- immediately after intervention- 3 months after intervention
Method of measurement
CFQ Quastinaire, WSCT test

3

Description
attention
Timepoint
before intervention- immediately after intervention- 3 months after intervention
Method of measurement
Reactio time, CPT test

Secondary outcomes

1

Description
quality of life
Timepoint
before intervention- immediately after intervention- 3 months after intervention
Method of measurement
questionaire

Intervention groups

1

Description
Intervention group: 8 sessions of cognitive rehabilitation group therapy with focus on attention, memory and executive function, for a duration of 4 weeks, 2 sessions in each week, lasts 45 to 60 mins
Category
Rehabilitation

2

Description
Control group: no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Medical Clinic
Full name of responsible person
Mani Arash M.D.
Street address
Psychiatry department, 4th floor, Imam Reza Medical Clinic, Nemazee SQ, Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Hashemi Seyed Basir
Street address
Vice chancellor for research, 6th floor, Shiraz University of Medical Sciences, Zand St.A
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mani Arash
Position
Assistant Professor and Member of Shiraz Psychiatric Group
Other areas of specialty/work
Street address
Psychiatry Department, Hafez Hospital, Abiverdi St, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 9319
Fax
Email
mania@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mani Arash
Position
Assistant proffesor and Member of Psychiatry Group
Other areas of specialty/work
Street address
Psychiatry Department, Hafez Hospital, Abiverdi St, Shiraz
City
Shiarz
Postal code
Phone
+98 71 3627 9319
Fax
Email
mania@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elnaz Chohedri
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Psychiatry Department, Hafez Hospital, Abiverdi St, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 9319
Fax
Email
elnaz_chohedri@yahoo.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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