To develop a serious game for assessment and improvement of cognitive status of patients with mild cognitive impairment(MCI).
Design
A before-after study without control group on 30 MCI patients , without blinding, to compare the MMSE and ACE-R score, before and after playing the game
Settings and conduct
According to the number of patients referred to Brain and Cognition Clinic in Iran University of Medical Sciences, 30 patients who are at the MCI stage will be selected using convenience and purposive sampling methods. Selecting patients, holding a briefing session, and implementing MMSE/ACE-R are accomplished by a neurologist in Brain and Cognition Clinic in Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
A neurologist should confirm the initial diagnosis of mild cognitive impairment in patients.
Participant should have almost the same medical test result.
Participants should not have disabilities in the upper limbs.
A neurologist should confirm participants have no other mental health problems.
Participants should be willing to participate in the study and complete the informed consent form.
Intervention groups
The participants are asked to play parts of the game as prescribed by a neurologist, three days a week, at least 45 min each time, for three months at home since the appointed date. Results of each game run are considered as a point and recorded along with the duration of the study. At the end of three months, Mini-Mental State Exam (MMSE) and Addenbrooke's Cognitive Examination-Revised (ACE-R) will be retaken from the participants by the same neurologist at the same location.
Main outcome variables
Mini-Mental State Exam (MMSE) score before and three months after playing games; Addenbrooke's Cognitive Examination-Revised (ACE-R) score before and three months after playing games
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211020052824N1
Registration date:2021-11-21, 1400/08/30
Registration timing:registered_while_recruiting
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
َAbbas Sheikhtaheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 4301
Email address
sheikhtaheri.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-12-11, 1400/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and Evaluation of Serious Games for Diagnosis and Cognitive Improvement of Patients with Mild Cognitive Impairment(MCI)
Public title
Serious games for patients with mild cognitive impairment (MCI)
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
A neurologist should confirm the initial diagnosis of MCI in patients.
Participants should have almost the same medical test results.
They should be willing to participate in the study and complete the informed consent form.
Exclusion criteria:
Participants have disabilities in the upper limbs.
participants have other mental health problems according to the neurologist.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14665354
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1397.1364
Health conditions studied
1
Description of health condition studied
Mild cognitive impairment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated
Primary outcomes
1
Description
Mini–Mental State Examination (MMSE) test score
Timepoint
At beginning of study and after three months
Method of measurement
This outcome will be measured using standard Mini–Mental State Examination (MMSE) test. MMSE is the most common test applied to assess cognitive impairment. MMSE has been translated into Persian and validated for Iranians. Implementing MMSE will be accomplished by a neurologist in Brain and Cognition Clinic in Iran University of Medical Sciences at the beginning of the study. At the end of three months, MMSE will be retaken from the participants by the same neurologist at the same location.
2
Description
Addenbrooke’s Cognitive Examination (ACE_R) test score
Timepoint
At beginning of study and after three months
Method of measurement
This outcome will be measured عsing Addenbrooke’s Cognitive Examination-Revised version tools. This test examines memory, language, and visual-spatial skills more broadly than MMSE and includes verbal fluency components. ACE-R has been translated into Persian and validated for Iranians. Implementing ACE-R will be accomplished by a neurologist in Brain and Cognition Clinic in Iran University of Medical Sciences at the beginning of the study. At the end of three months, ACE-R will be retaken from the participants by the same neurologist at the same location.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants will be asked to play parts of the game as prescribed by a neurologist, three days a week, at least 45 min each time, for three months at home since the appointed date. Results of each game will be considered as a point and recorded along with the duration of the study. The proposed game will be designed for Attention and orientation, Memory, Language, and Visuospatial aspects based on the cognitive aspects of ACE-R and MMSE tests. This game will be an Android-based game which will be developed by the researchers after conducting a systematic review on the available games. The proposed game contains some little games, and each of these games will be related with a cognitive aspect of these two tests.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain and cognitive clinic in Iran University of Medical Sciences
Full name of responsible person
Mostafa Almasi-Dooghaee
Street address
No 33, East Zartosht Ave, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8880 2063
Email
Almasidoghaei.m@iums.ac.ir
Web page address
https://bcclinic.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Sheikhtaheri
Street address
School of health management, Yasemi St, Valiasr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8878 2919
Fax
+98 21 8888 3334
Email
Sheikhtaheri@iums.ac.ir
Web page address
Https://iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical 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
Iran University of Medical Sciences
Full name of responsible person
Abbas Sheikhtaheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
School of Health Management and Information Sciences, No. 6, Rashid Yasemi St. Vali –e Asr Ave, Tehran, Iran. P.O Box: 1996713883
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8879 4301
Email
Sheikhtaheri.a@iums.ac.ir
Web page address
https://shmis.iums.ac.ir/fa?sid=34
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Sheikhtaheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
School of Health Management and Information Sciences, No. 6, Rashid Yasemi St. Vali –e Asr Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8879 4301
Email
Sheikhtaheri.a@iums.ac.ir
Web page address
https://shmis.iums.ac.ir/fa?sid=34
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farveh Sabermahani
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
School of Health Management and Information Sciences, No. 6, Rashid Yasemi St. Vali –e Asr Ave
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8878 2919
Email
Sabermahani.f@iums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The result of the systematic review regarding the game scenarios and their effectiveness.
Design consideration and the degree of correlation between the proposed game's score and the results of clinical tests.
The effect of the suggested game on the participants' cognitive abilities.
When the data will become available and for how long
From beginning of 2022
To whom data/document is available
Researchers who intended to the field of this study
Under which criteria data/document could be used
In selection or design serious game for patients with mild cognitive impairment
From where data/document is obtainable
Abbas Sheikhraheri
What processes are involved for a request to access data/document