Type 1 DiabetesNCT04866212
Comparison of Manual Skills, Visual-Motor Integration and Participation of Children With and Without Type 1 Diabetes
An observational study of Type 1 Diabetes and Hand Skills, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare visual-motor integration, academic achievement and participation in activities of daily living with and without type 1 diabetes. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Hand Skills, Visual Motor Integration
- What is being tested?
- Beery- Buktenica Developmental Test of Visual Motor Integration, Jebsen Taylor Hand Function Test and Participation and Environment Measure - Children and Youth
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2020to 16 Sep 2021
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with T1DM followed in Istanbul Medipol Mega University Hospital Pediatric Endocrinology Polyclinic. Healthy children and their parents will be selected from primary and secondary schools near the hospital.
Who may be able to join
- Being between the ages of 8 and 12,
- To be diagnosed with Type 1 diabetes,
- To be receiving education at primary education level,
- Children who agree to participate in the cooperative during the evaluations,
- Parents and children accepted to participate in the study.
Who cannot join
- Any acute or chronic illness that affects the level of physical activity,
- Other types of diabetes,
- Mental problems,
- Having received psychiatric treatment,
- Having vision problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hand Skills, Visual-Motor Integration and Participation in Activities of Daily Living of Children With and Without Type 1 Diabetes
The aim of this study is to compare visual-motor integration, academic achievement and participation in activities of daily living with and without type 1 diabetes.
Read the detailed description
There are two different groups in this study. The first group includes children with type 1 diabetes and the second group includes healthy children. Children aged 8-12 years were included in the evaluation. Beery-Buktenica Developmental Test of Visual Motor Integration , academic achievement (Turkish, mathematics, social sciences exam scores) Participation and Environment Measure-Children an Youth, Jebsen Taylor Hand Function Test were used for evaluation.
- Conditions
- Type 1 Diabetes, Hand Skills, Visual Motor Integration, Participation
- Being tested
- Beery- Buktenica Developmental Test of Visual Motor Integration, Jebsen Taylor Hand Function Test, Participation and Environment Measure - Children and Youth
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beery- Buktenica Developmental Test of Visual Motor IntegrationBehavioural
Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
Jebsen Taylor Hand Function TestBehavioural
Investigation of hand skills by Jebsen Taylor Hand Function Test
Participation and Environment Measure - Children and YouthDiagnostic test
Investigation of participation by Participation and Environment Measure - Children and Youth
| Study group | Role | What they receive |
|---|---|---|
| Children with Type 1 Diabetes Group | Children with type 1 diabetes were evaluated in terms of their hand skills, visual motor integration, participation in daily life activities and academic success.
Hand skills were evaluated using the Jebsen Taylor Hand Function Test. Participation was evaluated with Participation and Environment Measurement-Children and Youth. Visual motor integration was evaluated with Beery-Buktenica Developmental Test of Visual Motor Integration. Academic success was evaluated with the course success score. Receives: Behavioral: Beery- Buktenica Developmental Test of Visual Motor Integration; Behavioral: Jebsen Taylor Hand Function Test; Diagnostic Test: Participation and Environment Measure - Children and Youth | |
| Children without Type 1 Diabetes Group | Children without type 1 diabetes were evaluated in terms of their hand skills, visual motor integration, participation in daily life activities and academic success.
Hand skills were evaluated using the Jebsen Taylor Hand Function Test. Participation was evaluated with Participation and Environment Measurement-Children and Youth. Visual motor integration was evaluated with Beery-Buktenica Developmental Test of Visual Motor Integration. Academic success was evaluated with the course success score. Receives: Behavioral: Beery- Buktenica Developmental Test of Visual Motor Integration; Behavioral: Jebsen Taylor Hand Function Test; Diagnostic Test: Participation and Environment Measure - Children and Youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Motor Integration
Visual-motor integration (VMI) is "the degree to which visual perception and finger-hand movements are well coordinated" and will asses with Beery-Buktenica Developmental Test of Visual-Motor Integration in this study. This test is a standardized, norm-referenced assessment involving copying geometric forms that is used to determine the level of integration between visual and motor systems in people of all ages. The Short Format and Full Format tests take about 10-15 minutes each to administer. Results are reported as standard scores, percentiles, and age equivalents.
Measured: 30 minutes
Hand Skills
The Jebsen Taylor Hand Function Test (JTHFT) assesses both dominant and non-dominant hand skills and provides an objective assessment of hand function included in 7 subtests of daily living activities. The time (in seconds) to perform the 7 subtests is measured by the stopwatch. JTHFT is valid, reliable and normative for children.
Measured: 10-15 minutes
Participation
Participation and Environment Measurement- Children and Youth (PEM-CY) is a parent reported measure developed in North America. Evaluates the environmental factors affecting the participation of disabled and non-disabled children and young people. It examines three environments, home, school and environment, and discusses each environment in two parts as "participation and environment".
Measured: 25-40 minutes
academic achievement
Academic achievement was evaluated with Turkish, mathematics and social sciences course success points.
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start30 Apr 2020
- Primary completion16 Mar 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Cross-sectional
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehtap kilicoz, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866212
- Sponsor's protocol ID
- 10840098-604.01.01-E.14675
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hand Skills, Visual-Motor Integration and Participation in Activities of Daily Living of Children With and Without Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04866212
- Acronym / sponsor ID
- 10840098-604.01.01-E.14675
- Conditions
- Type 1 Diabetes, Hand Skills, Visual Motor Integration, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 29 Apr 2021 (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.
The aim of this study is to compare visual-motor integration, academic achievement and participation in activities of daily living with and without type 1 diabetes.
Detailed description
There are two different groups in this study. The first group includes children with type 1 diabetes and the second group includes healthy children. Children aged 8-12 years were included in the evaluation. Beery-Buktenica Developmental Test of Visual Motor Integration , academic achievement (Turkish, mathematics, social sciences exam scores) Participation and Environment Measure-Children an Youth, Jebsen Taylor Hand Function Test were used for evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Type 1 Diabetes Group | – | Behavioral: Beery- Buktenica Developmental Test of Visual Motor Integration, Behavioral: Jebsen Taylor Hand Function Test, Diagnostic Test: Participation and Environment Measure - Children and YouthChildren with type 1 diabetes were evaluated in terms of their hand skills, visual motor integration, participation in daily life activities and academic success. Hand skills were evaluated using the Jebsen Taylor Hand Function Test. Participation was evaluated with Participation and Environment Measurement-Children and Youth. Visual motor integration was evaluated with Beery-Buktenica Developmental Test of Visual Motor Integration. Academic success was evaluated with the course success score. |
| Children without Type 1 Diabetes Group | – | Behavioral: Beery- Buktenica Developmental Test of Visual Motor Integration, Behavioral: Jebsen Taylor Hand Function Test, Diagnostic Test: Participation and Environment Measure - Children and YouthChildren without type 1 diabetes were evaluated in terms of their hand skills, visual motor integration, participation in daily life activities and academic success. Hand skills were evaluated using the Jebsen Taylor Hand Function Test. Participation was evaluated with Participation and Environment Measurement-Children and Youth. Visual motor integration was evaluated with Beery-Buktenica Developmental Test of Visual Motor Integration. Academic success was evaluated with the course success score. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with T1DM followed in Istanbul Medipol Mega University Hospital Pediatric Endocrinology Polyclinic. Healthy children and their parents will be selected from primary and secondary schools near the hospital.
Key inclusion criteria (5 listed)
- Being between the ages of 8 and 12,
- To be diagnosed with Type 1 diabetes,
- To be receiving education at primary education level,
- Children who agree to participate in the cooperative during the evaluations,
- Parents and children accepted to participate in the study.
Key exclusion criteria (5 listed)
- Any acute or chronic illness that affects the level of physical activity,
- Other types of diabetes,
- Mental problems,
- Having received psychiatric treatment,
- Having vision problems.
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 |
|---|---|---|
| Beery- Buktenica Developmental Test of Visual Motor IntegrationInvestigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration. | Behavioural | Children with Type 1 Diabetes Group, Children without Type 1 Diabetes Group |
| Jebsen Taylor Hand Function TestInvestigation of hand skills by Jebsen Taylor Hand Function Test | Behavioural | Children with Type 1 Diabetes Group, Children without Type 1 Diabetes Group |
| Participation and Environment Measure - Children and YouthInvestigation of participation by Participation and Environment Measure - Children and Youth | Diagnostic test | Children with Type 1 Diabetes Group, Children without Type 1 Diabetes Group |
Primary outcome
Visual Motor Integration
Time frame: 30 minutes
Visual-motor integration (VMI) is "the degree to which visual perception and finger-hand movements are well coordinated" and will asses with Beery-Buktenica Developmental Test of Visual-Motor Integration in this study. This test is a standardized, norm-referenced assessment involving copying geometric forms that is used to determine the level of integration between visual and motor systems in people of all ages. The Short Format and Full Format tests take about 10-15 minutes each to administer. Results are reported as standard scores, percentiles, and age equivalents.
Hand Skills
Time frame: 10-15 minutes
The Jebsen Taylor Hand Function Test (JTHFT) assesses both dominant and non-dominant hand skills and provides an objective assessment of hand function included in 7 subtests of daily living activities. The time (in seconds) to perform the 7 subtests is measured by the stopwatch. JTHFT is valid, reliable and normative for children.
Participation
Time frame: 25-40 minutes
Participation and Environment Measurement- Children and Youth (PEM-CY) is a parent reported measure developed in North America. Evaluates the environmental factors affecting the participation of disabled and non-disabled children and young people. It examines three environments, home, school and environment, and discusses each environment in two parts as "participation and environment".
academic achievement
Time frame: 1 minutes
Academic achievement was evaluated with Turkish, mathematics and social sciences course success points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type 1 Diabetes and Hand Skills, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jun 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Motor Integration (time frame: 30 minutes). The study lists 4 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 7 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.