Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04866212
Other study ID # 10840098-604.01.01-E.14675
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2020
Est. completion date September 16, 2021

Study information

Verified date June 2024
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date September 16, 2021
Est. primary completion date March 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Intervention

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.
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

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary academic achievement Academic achievement was evaluated with Turkish, mathematics and social sciences course success points. 1 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT05653518 - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes N/A
Enrolling by invitation NCT05515939 - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed NCT05109520 - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting NCT04016987 - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes N/A
Active, not recruiting NCT04190368 - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes N/A
Recruiting NCT05413005 - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus Early Phase 1
Active, not recruiting NCT04668612 - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes N/A
Completed NCT02837094 - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 Phase 1
Recruiting NCT05414409 - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action Phase 2
Recruiting NCT05670366 - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes N/A
Active, not recruiting NCT05418699 - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed NCT04084171 - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 N/A
Recruiting NCT06144554 - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Recruiting NCT05153070 - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Phase 2
Completed NCT05281614 - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D Early Phase 1
Withdrawn NCT04259775 - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes N/A
Active, not recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02914886 - Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Phase 4
Completed NCT02897557 - Insulet Artificial Pancreas Early Feasibility Study N/A