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

NCT06206317 | Unknown

• 1 other identifier: erdalaydin.T1DM
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus (T1DM); Hand Grip Strength; Fine Grip Strength; Semmes-Weinstein Monofilaments; Sensation of the hand; hand functions; Pediatric Endocrinology Clinic; Vibration Sensation; Static Two-Point Discrimination; Functional Skills Test; Jebsen Taylor Hand Function Test (JTEFT)

Outcome Measures

Primary Outcomes (8)

• Hand Grip Strength Measurement

  Jamar Hydraulic Hand Dynamometer is used to measure hand grip strength in a standardized test position defined by the American Society of Hand Therapists. Measurements are taken for both the right and left hands, and average values are recorded in kilograms.

  1 minute

• Fine Grip Strength Assessment

  The "pinchmeter" is used to measure finger grip strength in lateral, palmar, and fingertip grasp positions. Three measurements are taken for each grip, and the results are recorded in kilograms.

  2 minute

• Jebsen Taylor Hand Function Test (JTEFT)

  This test is utilized to evaluate hand functions. It includes activities such as writing a sentence, flipping cards, picking up and placing small objects in a container, picking up beans using a teaspoon, stacking checkers, tossing lightweight cans, and heavier cans. Each activity must be completed within a designated time frame. Results are derived from the time taken to complete the activities.

  8 minute

• Functional Skills Test

  This test assesses fine motor skills. Using a pegboard, the child is instructed to turn over and place circular discs in sequence. The test measures completion time and speed.

  4 minute

• Semmes-Weinstein Monofilament Examination

  This test evaluates light touch/pressure sensation using monofilaments of varying pressure values. Applied at three points in areas innervated by the median and ulnar nerves, the test results are classified within specific ranges to assess changes in sensory perception.

  4 minute

• Vibration Test

  Vibratory sensation is measured using a 128 Hz diapason. The time taken by the patient to perceive the vibration applied to specific points is recorded using a stopwatch.

  4 minute

• Hot-Cold Assessment

  Using two tubes containing hot and cold water, the patient's ability to distinguish between hot and cold is tested within the dermatomal area. Results are evaluated based on the accuracy of identifying the temperatures.

  2 minute

• Static Two-Point Discrimination Test

  This test measures the ability to distinguish between two points applied simultaneously to the skin. A calibrated two-point discriminator is used to assess whether the individual can perceive whether it's one or two points being touched. The results are recorded based on the patient's ability to discern the two-point stimuli and are evaluated as the patient's two-point discrimination score. This test is an essential tool in assessing sensory capabilities in the hand.

  2 minute

Study Arms (2)

Study Group

Comprising children diagnosed with Type 1 Diabetes Mellitus (T1DM). This group constitutes the focal point of the study, assessing the motor and sensory functions of the hand. These children undergo various tests and measurements aimed at evaluating the motor skills, sensory perception, and functionality of the hand. The study solely involves evaluation and will not include any treatment or intervention.

Control Group

Consisting of children without any health issues. This group comprises healthy individuals and serves as a comparative reference against the study group. Similar tests and measurements are applied to assess the motor and sensory functions of the hand in healthy individuals for comparison with the study group. The study solely involves evaluation and will not include any treatment or intervention.

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will be conducted in the Pediatric Endocrinology Outpatient Clinic of Hatay Mustafa Kemal University, Health Practice and Research Hospital. The participants included in the study will be divided into 2 groups as the study group including those diagnosed with T1DM and the control group without any health problems. The study group will include children between the ages of 7-18 years who have been diagnosed with T1DM and who apply to the paediatric endocrinology outpatient clinic. In the control group; children between the ages of 7-18 years who agree to participate in the study, who do not have any health problems, who come to the hospital for control or who come to accompany their family members will be included.

You may qualify if:

• Accepting to participate in the study.
• Being diagnosed with T1DM.
• The consent of the family for the study has been obtained and the consent document has been signed.
• Being between the ages of 7-18 years.
• To be co-operative during the evaluations.
• Not having orthopedic and neurological problems that prevent the evaluation.

You may not qualify if:

• Refusal to participate in the study.
• Parents have not signed a consent form.
• Not being between the ages of 7-18.
• Not being able to co-operate during the evaluations.
• Having orthopedic and neurological problems that prevent the evaluation.
• Having an additional disease (celiac, autoimmune disease, etc.)
• Not being able to comply with the researcher's commands during the evaluation

Sponsors & Collaborators

• Erdal AYDIN: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sabiha Bezgin

  Mustafa Kemal University

  STUDY DIRECTOR

Central Study Contacts

Erdal AYDIN

CONTACT

+905456208598; fzt.erdalaydin@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: February 3, 2024
• Primary Completion: May 3, 2024
• Study Completion: June 3, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01