Comparison of Manual Skills, Visual-Motor Integration and Participation of Children With and Without Type 1 Diabetes

June 6, 2024 updated by: mehtap kilicoz, Istanbul Medipol University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Beykoz
      • Istanbul, Beykoz, Turkey
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Being between the ages of 8 and 12,
  2. To be diagnosed with Type 1 diabetes,
  3. To be receiving education at primary education level,
  4. Children who agree to participate in the cooperative during the evaluations,
  5. Parents and children accepted to participate in the study.

Exclusion Criteria:

  1. Any acute or chronic illness that affects the level of physical activity,
  2. Other types of diabetes,
  3. Mental problems,
  4. Having received psychiatric treatment,
  5. Having vision problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Beery- Buktenica Developmental Test of Visual Motor Integration
Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
Behavioral: Jebsen Taylor Hand Function Test
Investigation of hand skills by Jebsen Taylor Hand Function Test
Diagnostic test: Participation and Environment Measure - Children and Youth
Investigation of participation by 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.
Behavioral: Beery- Buktenica Developmental Test of Visual Motor Integration
Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
Behavioral: Jebsen Taylor Hand Function Test
Investigation of hand skills by Jebsen Taylor Hand Function Test
Diagnostic test: Participation and Environment Measure - Children and Youth
Investigation of participation by Participation and Environment Measure - Children and Youth

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 minutes
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.
10-15 minutes
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".
25-40 minutes
academic achievement
Time Frame: 1 minutes
Academic achievement was evaluated with Turkish, mathematics and social sciences course success points.
1 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10840098-604.01.01-E.14675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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