Type1diabetesNCT06673251
School Readiness in Children with Type 1 Diabetes
An observational study of Type1diabetes, run by arife akbulut.
Trial summary
It is known that motor and sensory functions are affected in children with type 1 diabetes (T1DM).This may cause children to have restrictions in their daily lives and decrease their participation in activities.Motor and sensory factors and participation are important factors affecting children's school readiness.This… Read more about this study
- Who is it for?
- Ages 60 to 78 monthsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes
- What is being tested?
- motor and sensory assessments, surveys
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 to 78 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: TYPE 1 DİABETES CHİLDREN
Who may be able to join
- Having been diagnosed with Type 1 DM in the last 6 months (for type 1 diabetes group) Being 60-78 months old
Who cannot join
- - Having any neurodevelopmental disorder in addition to diabetes (EX: cerebral palsy, down syndrome, muscular dystrophies..)
- Starting 1st grade
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Effects of Motor Performance, Sensory Processing, Quality of Life and Participation on School Readiness in Children with Type 1 Diabetes
It is known that motor and sensory functions are affected in children with type 1 diabetes (T1DM).This may cause children to have restrictions in their daily lives and decrease their participation in activities.Motor and sensory factors and participation are important factors affecting children's school readiness.This study was planned to investigate the effects of motor performance, sensory processing, quality of life and participation on school readiness in preschool children with T1DM.
- Conditions
- Type1diabetes
- Being tested
- motor and sensory assessments, surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor and sensory assessments, surveysOther
It does not include any intervention. Only evaluation will be made.
| Study group | Role | What they receive |
|---|---|---|
| children with type 1 diabetes | Not described Receives: Other: motor and sensory assessments, surveys | |
| Healthy children | Not described Receives: Other: motor and sensory assessments, surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
school readiness
Marmara primary school school readiness scale (60-78 months)
The scale consists of 2 forms:
- Development Form; It consists of a total of 153 behavioral items belonging to mental and language (74 items), socio-emotional (40 items), physical (23 items), self-care (16 items) skills.
Each item is graded as "always, often, sometimes, never" to be filled by the teacher or parents according to the frequency of the child's behavior.
- Application Form; Mathematics (number recognition, increase-decrease, sets -color, shape-, ordering: 47 questions), Science (induction, deduction, problem solving: 14 questions), Sound (words starting with the same sound, rhyming words: 8 questions) Line (3 questions) Maze (2 questions) It consists of 5 sub-dimensions prepared to be answered by the child one-on-one in order to determine their success in their studies. Each question is scored (31) with (1) points for the correct answer and (0) points for the wrong answer.
Measured: through study completion, an average of 1 year
motor performance
Bruininks-Oseretsky Motor Proficiency Test 2- (BOT 2) BOT 2 will be used to assess motor proficiency in children. BOT 2 is a test developed to assess fine and gross motor proficiency in children aged 4-21. The test duration can vary between 40 and 60 minutes for a child. The test consists of 8 subtests and 53 items. The maximum score that can be obtained from the test is 243. These are; fine motor skills (7 items - e.g.; Connecting the Dots), fine motor skill integrations (8 items - e.g.; Copying a Square), manual dexterity (5 items - e.g.; Classifying Shape Cards), bilateral coordination (7 items - e.g.; Sketch Jump), balance (9 items - e.g.; Walking on a Line), running speed and agility (5 items - e.g.; Sideways Jump on the Balance Beam), hand-arm coordination (7 items - e.g.; Dropping and Catching a Ball with Both Hands), strength (5 items - e.g.; Sit-up). A total motor composite score is also obtained from the total score of all items
Measured: through study completion, an average of 1 year
Quality of Life
Pediatric Quality of Life Inventory (PedsQL)) PedsQL is a scale developed to measure the health-related quality of life of children and adolescents between the ages of 2-18. The PedsQL, which was developed for the ages of two to seven, was adapted into Turkish by Üneri and colleagues , and for the ages of 8-18 by Çakın, Memik and colleagues . PedsQL has only parent-report forms for children between the ages of 2-5, and both self-report and parent forms for children/adolescents between the ages of 5-18. PedsQL consists of 23 items.
Measured: through study completion, an average of 1 year
Sensory Processing
The SPM Home Form consists of 75 items. The scale is evaluated with eight subscales: Social Participation, Vision, Hearing, Touch, Body Awareness, Balance and Movement, Planning and Ideas, and Total Sensory Systems in children aged 5-12. Total Sensory Systems represents the sum of the scores obtained from the Vision, Hearing, Touch, Body Awareness, Balance and Movement subscales and the Taste and Smell items, which are not subscales on their own. Each item is evaluated according to the frequency of the behavior with the expressions Never, Sometimes, Often, and Always. The Never option is given 1 point, the option is given 2 points, the option is given 3 points, and the option is given 4 points. Each item is related to a basic sensory integration sensitivity. In other words, the items can be interpreted as indicators of sensory overreactivity, underreactivity, sensory stimuli hunger, and a perception problem.
Measured: through study completion, an average of 1 year
participation
The Participation and Environment Measure for Children and Youth (PEM-CY) questionnaire will be used. The PEM-CY is a parent-report questionnaire used to assess participation and environmental factors in home, school, and community settings among children and youth ages 5-17. The PEMCY participation items for each setting represent a broad range of activities typically performed in that setting. For each activity type, parents are asked (a) how often their child participates (never=0 to every day=7); (b) how involved their child is when participating (at least=1 to a lot=5); and (c) whether they would like a change in their child's participation (no or yes). Parents are then asked questions that include the PEM-CY environmental items for each setting. Information is collected about whether certain features of the environment help children participate in activities in that environment (no problem, usually helps, sometimes helps/sometimes makes it difficult, usually makes it difficult)
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
physical fitness
The Munich Physical Fitness Test (MFUT) will be used to assess the physical fitness of children. The test consists of six different parameters including ball bouncing, target holding, forward bending, vertical jump, hanging and step test. After all parameters are completed, the score for each parameter is calculated from the standardization table appropriate for age and gender, and this total score is divided by six and recorded as the Munich score (20). MFUT has been shown to be a reliable and useful test in assessing important parameters of physical fitness such as strength, power, endurance, flexibility, speed, balance and coordination in children.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- arife akbulut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, arife akbulut, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673251
- Sponsor's protocol ID
- AYBU-AKBULUT-002
- Status last verified
- Oct 2024
- First submitted
- 14 Aug 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Motor Performance, Sensory Processing, Quality of Life and Participation on School Readiness in Children with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06673251
- Acronym / sponsor ID
- AYBU-AKBULUT-002
- Conditions
- Type1diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- arife akbulutUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Nov 2024 (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.
It is known that motor and sensory functions are affected in children with type 1 diabetes (T1DM).This may cause children to have restrictions in their daily lives and decrease their participation in activities.Motor and sensory factors and participation are important factors affecting children's school readiness.This study was planned to investigate the effects of motor performance, sensory processing, quality of life and participation on school readiness in preschool children with T1DM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with type 1 diabetes | – | Other: motor and sensory assessments, surveys |
| Healthy children | – | Other: motor and sensory assessments, surveys |
Who may qualify
- Ages
- 60 to 78 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- TYPE 1 DİABETES CHİLDREN
Key inclusion criteria (1 listed)
- Having been diagnosed with Type 1 DM in the last 6 months (for type 1 diabetes group) Being 60-78 months old
Key exclusion criteria (2 listed)
- - Having any neurodevelopmental disorder in addition to diabetes (EX: cerebral palsy, down syndrome, muscular dystrophies..)
- Starting 1st grade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor and sensory assessments, surveysIt does not include any intervention. Only evaluation will be made. | Other | Healthy children, children with type 1 diabetes |
Primary outcome
school readiness
Time frame: through study completion, an average of 1 year
Marmara primary school school readiness scale (60-78 months) The scale consists of 2 forms: A. Development Form; It consists of a total of 153 behavioral items belonging to mental and language (74 items), socio-emotional (40 items), physical (23 items), self-care (16 items) skills. Each item is graded as "always, often, sometimes, never" to be filled by the teacher or parents according to the frequency of the child's behavior. B. Application Form; Mathematics (number recognition, increase-decrease, sets -color, shape-, ordering: 47 questions), Science (induction, deduction, problem solving: 14 questions), Sound (words starting with the same sound, rhyming words: 8 questions) Line (3 questions) Maze (2 questions) It consists of 5 sub-dimensions prepared to be answered by the child one-on-one in order to determine their success in their studies. Each question is scored (31) with (1) points for the correct answer and (0) points for the wrong answer.
motor performance
Time frame: through study completion, an average of 1 year
Bruininks-Oseretsky Motor Proficiency Test 2- (BOT 2) BOT 2 will be used to assess motor proficiency in children. BOT 2 is a test developed to assess fine and gross motor proficiency in children aged 4-21. The test duration can vary between 40 and 60 minutes for a child. The test consists of 8 subtests and 53 items. The maximum score that can be obtained from the test is 243. These are; fine motor skills (7 items - e.g.; Connecting the Dots), fine motor skill integrations (8 items - e.g.; Copying a Square), manual dexterity (5 items - e.g.; Classifying Shape Cards), bilateral coordination (7 items - e.g.; Sketch Jump), balance (9 items - e.g.; Walking on a Line), running speed and agility (5 items - e.g.; Sideways Jump on the Balance Beam), hand-arm coordination (7 items - e.g.; Dropping and Catching a Ball with Both Hands), strength (5 items - e.g.; Sit-up). A total motor composite score is also obtained from the total score of all items
Quality of Life
Time frame: through study completion, an average of 1 year
Pediatric Quality of Life Inventory (PedsQL)) PedsQL is a scale developed to measure the health-related quality of life of children and adolescents between the ages of 2-18. The PedsQL, which was developed for the ages of two to seven, was adapted into Turkish by Üneri and colleagues , and for the ages of 8-18 by Çakın, Memik and colleagues . PedsQL has only parent-report forms for children between the ages of 2-5, and both self-report and parent forms for children/adolescents between the ages of 5-18. PedsQL consists of 23 items.
Sensory Processing
Time frame: through study completion, an average of 1 year
The SPM Home Form consists of 75 items. The scale is evaluated with eight subscales: Social Participation, Vision, Hearing, Touch, Body Awareness, Balance and Movement, Planning and Ideas, and Total Sensory Systems in children aged 5-12. Total Sensory Systems represents the sum of the scores obtained from the Vision, Hearing, Touch, Body Awareness, Balance and Movement subscales and the Taste and Smell items, which are not subscales on their own. Each item is evaluated according to the frequency of the behavior with the expressions Never, Sometimes, Often, and Always. The Never option is given 1 point, the option is given 2 points, the option is given 3 points, and the option is given 4 points. Each item is related to a basic sensory integration sensitivity. In other words, the items can be interpreted as indicators of sensory overreactivity, underreactivity, sensory stimuli hunger, and a perception problem.
participation
Time frame: through study completion, an average of 1 year
The Participation and Environment Measure for Children and Youth (PEM-CY) questionnaire will be used. The PEM-CY is a parent-report questionnaire used to assess participation and environmental factors in home, school, and community settings among children and youth ages 5-17. The PEMCY participation items for each setting represent a broad range of activities typically performed in that setting. For each activity type, parents are asked (a) how often their child participates (never=0 to every day=7); (b) how involved their child is when participating (at least=1 to a lot=5); and (c) whether they would like a change in their child's participation (no or yes). Parents are then asked questions that include the PEM-CY environmental items for each setting. Information is collected about whether certain features of the environment help children participate in activities in that environment (no problem, usually helps, sometimes helps/sometimes makes it difficult, usually makes it difficult)
1 secondary outcome
physical fitness
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by arife akbulut.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arife Akbulut Akbulut, Lecturer (+90 544-485-7922, arifeakbulut42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
school readiness (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 4 Nov 2024.