Determining the difference in the effectiveness of cognitive rehabilitation and neurofeedback on attention, working memory, emotional memory and emotional regulation in people with stroke in the post-test and follow-up stages.
Design
Clinical trial with control group, with parallel groups, randomized, on 45 patients.
Settings and conduct
In order to carry out the research, after obtaining the necessary permits from Payam Noor University of Tehran, by referring to Imam Reza Hospital and coordinating with the officials of this hospital, the necessary information regarding the implementation and importance of this research was provided to them. In the next step, after identifying a number of people who meet the criteria for entering the research, according to talking to the head of the brain injury department and examining the patients' files, they were asked to cooperate.
Participants/Inclusion and exclusion criteria
People with stroke aged 40 to 65 years
Intervention groups
Cognitive rehabilitation treatment for 8 sessions on experimental group 1 and neurofeedback treatment for 8 sessions on experimental group 2 and the third group received a combination of cognitive rehabilitation and neurofeedback treatment.
Main outcome variables
Attention, Working Memory, Emotional Memory and Emotion Regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230925059514N1
Registration date:2023-10-24, 1402/08/02
Registration timing:retrospective
Last update:2023-10-24, 1402/08/02
Update count:0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
tayebeh mousabeygi
Name of organization / entity
Payame Noor University
Country
Iran (Islamic Republic of)
Phone
+98 21 2229 5747
Email address
mousabeygi_tayebeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-01-30, 1401/11/10
Actual recruitment start date
2022-12-31, 1401/10/10
Actual recruitment end date
2023-01-30, 1401/11/10
Trial completion date
2023-01-30, 1401/11/10
Scientific title
The Effect of Cognitive Rehabilitation and Neurofeedback on Attention, Working Memory, Emotional Memory and Emotion Regulation in People with Stroke
Public title
The Effect of Cognitive Rehabilitation and Neurofeedback on Attention, Working Memory, Emotional Memory and Emotion Regulation in People with Stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 40 to 65 years
Suffering from one of the types of thrombotic, ischemic and hemorrhagic stroke and definitive diagnosis of the disease by a specialist doctor
More than 3 months have not passed since their illness
Exclusion criteria:
Participation in other similar psychological intervention programs History of other psychiatric diseases
Absence in more than 3 treatment sessions
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, block
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 Payame Noor University of Tehran
Street address
No. 27, Falahpour Ave., Ferdosi Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1599959515
Approval date
2022-12-21, 1401/09/30
Ethics committee reference number
IR.PNU.REC.1401.405
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.3
ICD-10 code description
Brain stem stroke syndrome
Primary outcomes
1
Description
Attention, Working Memory, Emotional Memory and Emotion Regulation
Timepoint
Measurement of attention, working memory, emotional memory and emotional regulation at the beginning of the study (before the start of the intervention), 60 days after the start of the intervention and 60 days after the end of the intervention
Method of measurement
Gross Emotion Regulation Questionnaire, Kaheel Emotional Memory Test, Working Memory Test (N-Back), Wisconsin Card Sorting Test
Secondary outcomes
1
Description
Executive functions
Timepoint
Measurement of Executive functions at the beginning of the study (before the start of the intervention), 60 days after the start of the intervention and 60 days after the end of the intervention
Method of measurement
Wisconsin card classification test
Intervention groups
1
Description
Intervention group: Cognitive Rehabilitation
Category
Other
2
Description
Intervention group: Neurofeedback
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Sirous nasiri
Street address
the end of the nurse's Blvd, Kermanshah Town
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6300
Email
irhk@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Payam Noor university
Full name of responsible person
Vice President of Research and Technology of Payam Noor University
Street address
Payam Noor University, Nakhel Street, Army Blvd., Mini City, Tehran
City
Tehran
Province
Tehran
Postal code
19395-4697
Phone
+98 21 2332 0000
Email
NETadmin@pnu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payam Noor 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
Payam Noor university
Full name of responsible person
Tayebeh Mousabeygi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Payam Noor University, Shahnaz Alley, Safa Alley, Mahmoud Nouryan St., North Dibaji St., Fermaniyeh, Tehran
City
Tehran
Province
Tehran
Postal code
1953633511
Phone
+98 21 2229 5747
Email
mousabeygi_tayebeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Payam Noor university
Full name of responsible person
Dr. Hossein Zare
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Payam Noor University, Shahnaz Alley, Safa Alley, Mahmoud Nouryan St., North Dibaji St., Fermaniyeh, Tehran
City
Tehran
Province
Tehran
Postal code
1953633511
Phone
+98 21 2229 5747
Email
h_zare@pnu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Payam Noor university
Full name of responsible person
Tayebeh Mousabeygi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Payam Noor University, Shahnaz Alley, Safa Alley, Mahmoud Nouryan St., North Dibaji St., Fermaniyeh, Tehran
City
Tehran
Province
Tehran
Postal code
1953633511
Phone
+98 21 2229 5747
Email
mousabeygi_tayebeh@yahoo.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
No - There is not a plan to make this available
Title and more details about the data/document
The results related to the comparison of the effectiveness of the treatments on the dependent variables are presented.
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of the article is allowed by mentioning the source
From where data/document is obtainable
Corresponding author's email
What processes are involved for a request to access data/document