Developing a Group Attention Rehabilitation Program and Investigating its Efficacy on Attention and Emotional Outcomes in Patients with Ischemic Stroke
The Main Purpose:
Developing a Group Attention Rehabilitation Program and Investigating its Efficacy on Attention and Emotional Outcomes (Anxiety and Depression) in Patients with Ischemic Stroke
Design
A Clinical Trial with a Control Group, with a Parallel Design, Double-Blind, Randomized, on 30 Patients. The Last National Identity Code Number of Patients is used for Randomization
Settings and conduct
The Participants are Patients of one or more Neurologists in Tehran. After Review of Records and Referral from the Specialist, and Review of Inclusion and Exclusion Criteria, Eligible Participants are Randomly Assigned to the Study Groups. In this Study, the Experimental Group Receives the Developed Intervention for 10 to 15 Sessions. The Control Group is Active and Receives a General Educational Intervention During the Same Period. Before the Program Starts, After it Finishes, As well as One Month after its Completion, Assessment are Made to Measure the Amount of Possible Changes from Each of the Participants. This Study is Conducted in a Psychological Center Located in Tehran.
Participants/Inclusion and exclusion criteria
Patients with Ischemic Stroke who are in a Stable Condition
Intervention groups
The Experimental Group will Receive the Target Intervention Which is an Attention Rehabilitation Program and the Control Group will Receive the Educational Intervention Which is simply an Intervention to Inform them about Their Disease and its Course
Developing a Group Attention Rehabilitation Program and Investigating its Efficacy on Attention and Emotional Outcomes in Patients with Ischemic Stroke
Public title
Developing a Rehabilitation Program in Patients with Stroke
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having Diagnostic Criteria for Ischemic Stroke
Signing the Ethical Consent Form to Participate in the Study (by the person himself/herself or his/her First-Degree Companions)
Age between 18 and 65 years
Being in the Sub-Acute and Chronic Stage of Stroke, according to Specialist Diagnosis
Having the Ability to Read and Write in Persian
Obtaining a score of 22 or lower in Montreal Cognitive Assessment (MoCA)
Exclusion criteria:
Obtaining a score of 10 or lower in Montreal Cognitive Assessment (MoCA)
Having an Unstable Medical Condition, as Diagnosed by a Specialist (eg, Epilepsy or Uncontrolled Diabetes)
Having Other Severe Neuro-Cognitive Disorders, as Diagnosed by a Specialist (eg, Aphasia)
Drug or Alcohol Addiction
Having Movement Limitations that Prevent Training and Intervention Exercises
Getting Another Cognitive Rehabilitation Method
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization, Based on the Last Digit of the National Identity Code of Each Participant (Even or Odd); Even Numbers will be in the Intervention Group and Odd Numbers will be in the Control Group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Main Purpose of this Study and the Provided Interventions are Not Directly Told to the Participants; They are Only Told that the Interventions They Receive are Aimed to Improve their Quality of Life after Stroke. Also, the Participants of Each Group will Not be in Contact with the Other Group. Moreover, the Analyst does Not Know the code of Intervention Which would be Assigned to Each Participant.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Institute for Cognitive Science Studies
Street address
Institute for Cognitive Science Studies, Cognitive Science Blvd, Edalat Roundabout, Pardis
City
Tehran
Province
Tehran
Postal code
1658344575
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.UT.IRICSS.REC.1402.012
Health conditions studied
1
Description of health condition studied
Ischemic Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Sustained Attention
Timepoint
Before the Intervention, After the Intervention, 1 Month after the Intervention
Method of measurement
Integrated Visual and Auditory Continuous Performance Test - 2 (IVACPT - 2) and Trail Making Test - Part A (TMT-A)
2
Description
Selective Attention
Timepoint
Before the Intervention, After the Intervention, 1 Month after the Intervention
Method of measurement
Stroop Test
3
Description
Alternating Attention
Timepoint
Before the Intervention, After the Intervention, 1 Month after the Intervention
Method of measurement
Trail Making Test - Part B (TMT-B)
4
Description
Divided Attention
Timepoint
Before the Intervention, After the Intervention, 1 Month after the Intervention
Method of measurement
Letter-Number Sequencing Test
Secondary outcomes
1
Description
Anxiety
Timepoint
Before the Intervention, After the Intervention, 1 Month after the Intervention
Method of measurement
Beck Anxiety Inventory (BAI)
2
Description
Depression
Timepoint
Before the Intervention, After the Intervention, 1 Month after the Intervention
Method of measurement
Beck Depression Inventory (BAI)
Intervention groups
1
Description
Intervention group: Group Attention Rehabilitation Program
Category
Rehabilitation
2
Description
Control group: General Education about the Disease and its Course
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Centers of Iran University of Medical Sciences
Full name of responsible person
Mohammad Taghi Joghataei
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
joghataei.mt@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Javad Hatami
Street address
Institute for Cognitive Science Studies, Cognitive Science Blvd, Edalat Roundabout, Pardis
City
Tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Email
sajjad.montazerghaem@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute for Cognitive Science Studies
Proportion provided by this source
30
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
Institute for Cognitive Science Studies
Full name of responsible person
Sajjad Montazerghaem
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Cognitive Psychology
Street address
Institute for Cognitive Science Studies, Cognitive Science Blvd, Edalat Roundabout, Pardis
City
Tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Email
sajjad.montazerghaem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Javad Hatami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Cognitive Psychology
Street address
Institute for Cognitive Science Studies, Cognitive Science Blvd, Edalat Roundabout, Pardis
City
Tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Email
hatamijm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Sajjad Montazerghaem
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Cognitive Psychology
Street address
Institute for Cognitive Science Studies, Cognitive Science Blvd, Edalat Roundabout, Pardis
City
Tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Email
sajjad.montazerghaem@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