NCT06206317

Comparison of Motor and Sensory Functions of the Hand in Children With Type 1 Diabetes Mellitus and Their Healthy Peers

Status unknown Last updated 17 January 2024

What this trial tests

trial in Type1 Diabetes Mellitus in 140 participants. Status unknown.

Timeline

3 February 2024

Primary endpoint
3 May 2024

3 June 2024

Quick facts

Lead sponsor	Erdal AYDIN
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	140
Start date	3 February 2024
Primary completion	3 May 2024
Estimated completion	3 June 2024

Conditions studied

• Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →

Sponsor

Erdal AYDIN

Who can join

Adults 7 to 18, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Type 1 Diabetes Mellitus (T1DM) is a condition where the body cannot produce a hormone called insulin. Although it is commonly seen in children and young people, it can occur at any age. The effects of T1DM on hand functions in children, particularly, have not been thoroughly researched yet. However, studies indicate that children diagnosed with diabetes may experience weakness in wrist muscles, reduced sensitivity in fingers, and impaired hand coordination. This study aimed to compare the motor and sensory functions of hands in children with T1DM against healthy children.

This study will compare children with T1DM to healthy children. Children will be divided into two groups: one group comprising children with T1DM, and the other including healthy children with no medical conditions. Children between the ages of 7-18 diagnosed with T1DM will participate in the study. The healthy control group will consist of children without any health issues within the same age range who visit the hospital for routine check-ups. In total, 140 children will be included in the study, with 70 children having diabetes and 70 healthy children.

Tests used in the study:

* The Jebsen Taylor Hand Function Test (JTEFT) is a standard test used to assess hand functions, consisting of 7 different sub-tests.
* The Functional Skill Test (FBT) is utilized to evaluate children's fine motor skills.
* Handgrip strength will be measured using the jamar hydraulic Hand Dynamometer.
* Fine grip strength is assessed using a device called Baseline®, measuring finger grip strength with different grips.
* Semmes-Weinstein monofilaments (SWM) are used to test light touch/pressure sensation. \*Monofilaments are applied to specific points, determining the lightest pressure level the patient feels.
* A discriminator is used for static two-point discrimination measurement, testing whether the patient can feel two separate points.
* Vibration sensation is measured by touching at a specific frequency.
* For Hot-Cold Assessment, tubes with different temperature water are used, and the person is asked to identify which tube feels hot or cold.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.