ChildrenNCT06865248
Psychometric Properties of the Turkish Version of the Modified Mini Mental State Examination
An observational study of Children and Neurologic Disorder, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
One of the most commonly used screening tests for the mental status of adults is the Standardized Mini Mental State Examination (MMSE). The MMSE is designed to screen for cognitive dysfunction, assess the severity of impairments, and identify changes over time. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Neurologic Disorder, Cerebral Palsy
- How many people
- 397 participants
- Where
- 1 siteCyprus
- Study dates
- Apr 2025to Jun 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children aged between the years of 5 and 18 who were diagnosed with neurodevelopmental disorders (Attention Deficit and Hyperactivity Disorder, Specific Learning Disorder, Autism Spectrum Disorder, Motor Disorders (Spastic SP)
Who may be able to join
- Between the ages of 5-18,
- Children diagnosed with neurodevelopmental disorders (Attention Deficit and Hyperactivity Disorder, Specific Learning Disorder, Autism Spectrum Disorder, Motor Disorders (Spastic SP)
- Children who can understand and apply Turkish commands
Who cannot join
- Those with have serious hearing and speech problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of Psychometric Properties of the Turkish Version of the Modified Mini Mental State Examination in Typically Developing Children and Children With Neurodevelopmental Disorders
One of the most commonly used screening tests for the mental status of adults is the Standardized Mini Mental State Examination (MMSE). The MMSE is designed to screen for cognitive dysfunction, assess the severity of impairments, and identify changes over time. In the country of the researchers, the Turkish adaptation of the MMSE for children has not been done and the validity and reliability of the Turkish version has not been demonstrated. This paper aims to investigate the pschiatric features of the MMSE for Turkish pediatric population.
Read the detailed description
Cerebral Palsy progresses with neurosensory, behavioral and cognitive disorders, especially restrictive adaptive behaviors, and a wider range of symptoms and functional disorders (1). Cognitive functions are all the brain functions required to receive stimuli from the outside and inside, select stimuli, create responses and coordinate with the environment (2). During childhood, cognitive functions can be negatively affected by many diseases, conditions or health problems. Evaluation of cognitive functions is important to determine whether cognitive abilities deviate from normal, to treat and monitor them. For this reason, many different tests are used in different age groups. These are; Montreal cognitive assessment (MoCA), Raven matrices, Wechsler adult intelligence scale (WAIS), Rey-identity and response memory test, Bender visual motor perception test, Delis-kaplan verbal reasoning test (D-KEFS), Stroop Test and Verbal memory tests are some of them. These tests are usually specific to their fields and may require trained professionals for long application periods. One of the most commonly used screening tests for adults is the Standardized Mini Mental State Examination (MMSE). The MMSE is designed to screen for cognitive dysfunctions, assess the severity of the disorders, and determine changes over time. The MMSE was developed by Folstein and colleagues (3) to rapidly assess cognitive functions. It consists of five sections: orientation, registration, attention and calculation, recall, and language, and is scored out of 30 points. Some of the existing screening tools used in childhood are limited in their use due to their reliance on parental reports, unknown correlations with general intelligence, the need for motor skills, literacy, and lack of sensitivity to developmental change. Therefore, it has been determined that there is a need for low-cost, rapidly administerable short cognitive screening tools that will allow rapid assessment of a wide range of cognitive domains in childhood. In this context, pediatric versions of the MMSE have begun to be used in various countries, such as Australia (4), India (5), Niger (6), Spain (7), and the USA (8). However, the psychometric properties of the MMSE in children with CP have only been reported in Brazil by Moura et al. (9). The Turkish adaptation of the MMSE has not been made for children and the validity and reliability of the Turkish version has not been demonstrated.
- Conditions
- Children, Neurologic Disorder, Cerebral Palsy, Down Syndrome, Healthy
- Medical subject headings
- Nervous System Diseases, Cerebral Palsy, Down Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Mini Mental State Examination
Its scoring is between 0-12. For attention; it consists of 2 sub-items as counting forward and backward. The total score is between 0-7. For sensory perception; the child will be asked to name 3 known objects (pen, watch, glasses). Its scoring is between 0-3. For recall; the child will be asked to show and explain the previous 3 objects (pen, watch, glasses). Its scoring is between 0-3. For language; first, the child will be asked to name the 5 determined body parts (hand, foot, knee, nose, ear), second, they will be asked to carry out a 3-stage command, third, they will be asked to repeat a tongue twister, fourth, they will be asked to read and apply the shown text (close their eyes), fifth, they will be asked to write their name and finally they will be asked to draw the shown shape. Scoring ranges from 0 to 12. The highest score that can be obtained from the Modified MMSE is 37. Application time is between 8-15 minutes.
Measured: at baseline and on the 7th day from the baseline
Secondary outcomes (2)
Colored Progressive Matrices Test (RPM)
In each matrix consisting of meaningless shapes in parts called A, AB and B, there is a shape with a missing part. It will be asked to find the correct one from the 6 options that complete the missing part in the bottom part. It will receive 1 point for each correct answer.
Measured: at baseline and on the 7th day from the baseline
Functional Independence Measure for Children (WeeFIM)
It consists of 6 sections including self-care (eating, washing hands and face, brushing teeth, toileting, bathing and dressing), sphincter control (bladder and bowel habits), transfer (transfer to toilet, shower and chair), locomotion (walking, crawling, going up and down stairs), communication (understanding and expressing) and social status (social relationships, problem solving and memory) and contains a total of 18 items. The family will be asked to score each item in these sections from 1 to 7 according to whether the individual received help while performing the function, whether he/she did it on time or whether an assistive device was required. The "Self-Care" subscale will be used in this study. The child's level of independence in daily life will be recorded by asking 6 questions here.
Measured: at baseline and on the 7th day from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 397 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emine HANDAN TÜZÜN, Prof., Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865248
- Sponsor's protocol ID
- ETK000000001
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Psychometric Properties of the Turkish Version of the Modified Mini Mental State Examination in Typically Developing Children and Children With Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT06865248
- Acronym / sponsor ID
- ETK000000001
- Conditions
- Children, Neurologic Disorder, Cerebral Palsy, Down Syndrome, Healthy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 397 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most commonly used screening tests for the mental status of adults is the Standardized Mini Mental State Examination (MMSE). The MMSE is designed to screen for cognitive dysfunction, assess the severity of impairments, and identify changes over time. In the country of the researchers, the Turkish adaptation of the MMSE for children has not been done and the validity and reliability of the Turkish version has not been demonstrated. This paper aims to investigate the pschiatric features of the MMSE for Turkish pediatric population.
Detailed description
Cerebral Palsy progresses with neurosensory, behavioral and cognitive disorders, especially restrictive adaptive behaviors, and a wider range of symptoms and functional disorders (1). Cognitive functions are all the brain functions required to receive stimuli from the outside and inside, select stimuli, create responses and coordinate with the environment (2). During childhood, cognitive functions can be negatively affected by many diseases, conditions or health problems. Evaluation of cognitive functions is important to determine whether cognitive abilities deviate from normal, to treat and monitor them. For this reason, many different tests are used in different age groups. These are; Montreal cognitive assessment (MoCA), Raven matrices, Wechsler adult intelligence scale (WAIS), Rey-identity and response memory test, Bender visual motor perception test, Delis-kaplan verbal reasoning test (D-KEFS), Stroop Test and Verbal memory tests are some of them. These tests are usually specific to their fields and may require trained professionals for long application periods. One of the most commonly used screening tests for adults is the Standardized Mini Mental State Examination (MMSE). The MMSE is designed to screen for cognitive dysfunctions, assess the severity of the disorders, and determine changes over time. The MMSE was developed by Folstein and colleagues (3) to rapidly assess cognitive functions. It consists of five sections: orientation, registration, attention and calculation, recall, and language, and is scored out of 30 points. Some of the existing screening tools used in childhood are limited in their use due to their reliance on parental reports, unknown correlations with general intelligence, the need for motor skills, literacy, and lack of sensitivity to developmental change. Therefore, it has been determined that there is a need for low-cost, rapidly administerable short cognitive screening tools that will allow rapid assessment of a wide range of cognitive domains in childhood. In this context, pediatric versions of the MMSE have begun to be used in various countries, such as Australia (4), India (5), Niger (6), Spain (7), and the USA (8). However, the psychometric properties of the MMSE in children with CP have only been reported in Brazil by Moura et al. (9). The Turkish adaptation of the MMSE has not been made for children and the validity and reliability of the Turkish version has not been demonstrated.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children aged between the years of 5 and 18 who were diagnosed with neurodevelopmental disorders (Attention Deficit and Hyperactivity Disorder, Specific Learning Disorder, Autism Spectrum Disorder, Motor Disorders (Spastic SP)
Key inclusion criteria (3 listed)
- Between the ages of 5-18,
- Children diagnosed with neurodevelopmental disorders (Attention Deficit and Hyperactivity Disorder, Specific Learning Disorder, Autism Spectrum Disorder, Motor Disorders (Spastic SP)
- Children who can understand and apply Turkish commands
Key exclusion criteria (1 listed)
- Those with have serious hearing and speech problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Mini Mental State Examination
Time frame: at baseline and on the 7th day from the baseline
Its scoring is between 0-12. For attention; it consists of 2 sub-items as counting forward and backward. The total score is between 0-7. For sensory perception; the child will be asked to name 3 known objects (pen, watch, glasses). Its scoring is between 0-3. For recall; the child will be asked to show and explain the previous 3 objects (pen, watch, glasses). Its scoring is between 0-3. For language; first, the child will be asked to name the 5 determined body parts (hand, foot, knee, nose, ear), second, they will be asked to carry out a 3-stage command, third, they will be asked to repeat a tongue twister, fourth, they will be asked to read and apply the shown text (close their eyes), fifth, they will be asked to write their name and finally they will be asked to draw the shown shape. Scoring ranges from 0 to 12. The highest score that can be obtained from the Modified MMSE is 37. Application time is between 8-15 minutes.
2 secondary outcomes
Colored Progressive Matrices Test (RPM)
Time frame: at baseline and on the 7th day from the baseline
Functional Independence Measure for Children (WeeFIM)
Time frame: at baseline and on the 7th day from the baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Related trials for Children
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emine HANDAN TÜZÜN, Prof. study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children and Neurologic Disorder, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZEHRA GÜÇHAN TOPCU, Assoc. Prof (+903926303067 ext. 2496, zehra.guchan@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Mini Mental State Examination (time frame: at baseline and on the 7th day from the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.