Protocol summary

Study aim
The effect of computer-based cognitive restoration on improving memory, attention and executive function in patients with dementia
Design
This study was performed as a clinical trial with parallel and randomized groups on 30 patients with dementia due to stroke and these patients were randomly divided into two groups of education and control.
Settings and conduct
First, patients who meet the inclusion criteria will be examined and randomly assigned to the control and experimental groups, and then cognitive rehabilitation will be performed in 15 sessions of 30 minutes at the Baghcheban Cognitive Rehabilitation Clinic in Arak for the experimental group. Finally, the two groups will be evaluated for dependent outcomes.
Participants/Inclusion and exclusion criteria
inclusion criteria : Patients with dementia who have had a stroke for at least 3 months , age 30-70 years old Non-entry criteria : Having diabetes , Cerebral venous thrombosis , Head and neck injuries , History of chronic heart failure with EF less than 30% , History of dementia medications
Intervention groups
Intervention group: The protocol of cognitive rehabilitation intervention using a computer includes training on the functions of continuous attention, selective attention, focused attention, continuous attention, response inhibition, and short-term memory in each session, respectively. The number of cognitive rehabilitation sessions is 20 30-minute sessions twice a week. This protocol is based on Sulberg & Matter's (2004) Attention Processing Training Protocol. Control group: No educational intervention.
Main outcome variables
n order to perform pre-test and post-test for the "attention" variable, continuous and simple stropping tests will be used, for the "memory" variable, MoCA and MMSE, and for the "executive performance" variable, the Wisconsin test will be used.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191104045328N8
Registration date: 2022-01-01, 1400/10/11
Registration timing: prospective

Last update: 2022-01-01, 1400/10/11
Update count: 0
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of computer-based cognitive rehabilitation therapy in improving memory, attention and executive function of patients with dementia after stroke
Public title
The effect of computer-based cognitive restoration on improving memory, attention and executive function in patients with dementia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with dementia who have had a stroke for at least 3 months. age 30-70
Exclusion criteria:
Having diabetes Cerebral venous thrombosis Head and neck injuries History of chronic heart failure with EF less than 30% History of dementia medications
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in.
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 Islamic Azad University, Arak Branch
Street address
Arak, Imam Khomeini Square, Imam Khomeini Boulevard, 3 km of Khomeini Road, Amirkabir University Town
City
Arak
Province
Markazi
Postal code
3836119131
Approval date
2021-08-29, 1400/06/07
Ethics committee reference number
IR.IAU.ARAK.REC.1400.019

Health conditions studied

1

Description of health condition studied
Stroke dementia
ICD-10 code
F01.51
ICD-10 code description
Vascular dementia with behavioral disturbance

Primary outcomes

1

Description
Attention
Timepoint
Before and after the intervention
Method of measurement
continuous and simple stropping tests

2

Description
Memory
Timepoint
Before and after the intervention
Method of measurement
Montreal cognitive assessment and Mini-Mental state examination

3

Description
executive performance
Timepoint
Before and after the intervention
Method of measurement
Wisconsin test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The protocol of cognitive rehabilitation intervention using a computer includes training on the functions of continuous attention, selective attention, focused attention, continuous attention, response inhibition, and short-term memory in each session, respectively. The number of cognitive rehabilitation sessions is 20 30-minute sessions twice a week. This protocol is based on Sulberg & Matter's (2004) Attention Processing Training Protocol.
Category
Behavior

2

Description
Control group: No educational intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Amir Kabir Hospital
Full name of responsible person
Dr Mostafa Nokani
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
m.nokani@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ali Hasani Josheghani
Street address
Arak, Imam Khomeini Square, Imam Khomeini Boulevard, 3 km of Khomeini Road, Amirkabir University Town
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 86 3413 2451
Fax
+98 86 3413 2451
Email
a-hasani@iau-arak.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Rezvan Nemati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Arak, Kowsar alley, Sepas complex, block C4, 11th floor, unit 62
City
Arak
Province
Markazi
Postal code
8079838481
Phone
+98 86 3413 2451
Fax
+98 86 3413 2451
Email
R.nemati9295@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Leila Poursadat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Arak, Sardasht, Basij Square, Complex of the Great Prophet (PBUH)
City
Arak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3417 3638
Fax
+98 86 3417 3638
Email
Porsaadat@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rezvan Nemati
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Arak, Kowsar alley, Sepas complex, block C4, 11th floor, unit 62
City
Arak
Province
Markazi
Postal code
8079838481
Phone
+98 86 3413 2451
Fax
+98 86 3413 2451
Email
R.nemati9295@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
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will be from 2022/4/20 to 2026/4/20 for 4 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
If there are any further questions
From where data/document is obtainable
Dr Mostafa Nokani
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.
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