NCT04866212

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2021

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

April 27, 2021

Last Update Submit

June 6, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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".

    25-40 minutes

  • academic achievement

    Academic achievement was evaluated with Turkish, mathematics and social sciences course success points.

    1 minutes

Study Arms (2)

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 IntegrationBehavioral: Jebsen Taylor Hand Function TestDiagnostic 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.

Behavioral: Beery- Buktenica Developmental Test of Visual Motor IntegrationBehavioral: Jebsen Taylor Hand Function TestDiagnostic Test: Participation and Environment Measure - Children and Youth

Interventions

Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.

Children with Type 1 Diabetes GroupChildren without Type 1 Diabetes Group

Investigation of hand skills by Jebsen Taylor Hand Function Test

Children with Type 1 Diabetes GroupChildren without Type 1 Diabetes Group

Investigation of participation by Participation and Environment Measure - Children and Youth

Children with Type 1 Diabetes GroupChildren without Type 1 Diabetes Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc student

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 29, 2021

Study Start

April 30, 2020

Primary Completion

March 16, 2021

Study Completion

September 16, 2021

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations