Comparison of Motor and Sensory Functions of the Hand in Children With Type 1 Diabetes Mellitus and Their Healthy Peers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Erdal AYDIN
- 入组人数
- 140
- 主要终点
- Hand Grip Strength Measurement
研究概览
简要总结
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.
详细描述
Type 1 Diabetes Mellitus (T1DM) is a metabolic disorder characterized by complete insulin deficiency, typically resulting from the destruction of beta cells, and identified by elevated blood sugar levels. T1DM is commonly observed in children and adolescents but can occur at any age. Microvascular complications such as visual impairment, kidney disease, neuropathy, and diabetic foot ulcers can arise in individuals with T1DM. Various musculoskeletal disorders like Dupuytren's syndrome, osteoporosis, osteopenia, adhesive capsulitis, carpal tunnel syndrome, and limited joint mobility syndrome can also be observed in individuals with T1DM. Limited joint mobility syndrome has been reported in 38-58% of type 1 diabetic patients, showing increased stiffness in the hand. The increased stiffness in the hand leads to fixed flexion contracture in the hand joints, disrupting fine motor skills and grip strength. The Semmes-Weinstein monofilament examination can predict foot ulceration and amputation risk in diabetic patients and aid in detecting diabetic peripheral neuropathy. Vibration testing, along with the Semmes-Weinstein monofilament examination, can detect diabetic peripheral neuropathy. A study by Hirschfeld et al. indicated that vibration testing exhibits high specificity for detecting diabetic peripheral neuropathy in children and adolescents. In a study conducted by Ising et al. in 2018, altered vibrotactile sensation indicative of diabetic peripheral neuropathy was found in 1/5 of adolescents and children. Reduced joint mobility in the hand, along with sensory loss, can also lead to decreased grip strength. A condition associated with insulin resistance and glucose metabolism in adolescents has been linked to grip ability. According to American Diabetes Association (ADA), individuals diagnosed with T1DM should be screened for diabetic peripheral neuropathy annually, starting within five years of the T1DM diagnosis. These screenings should assess thermal discrimination, vibratory sensation using a 128-hertz (Hz) tuning fork, and light touch sensation using a 10g monofilament test to determine ulceration and amputation risk.
Objective of our study: To compare the motor and sensory functions of the hand in children diagnosed with Type 1 Diabetes Mellitus with those of healthy peers.
Materials and Methods:
This study will be conducted at the Pediatric Endocrinology Clinic of Health Practice and Research Hospital. Participants will be divided into two groups: a study group consisting of individuals diagnosed with T1DM and a control group without any health issues. The study group will include children aged 7-18 years who have been diagnosed with T1DM and are seeking care at the pediatric endocrinology clinic. The control group will comprise children aged 7-18 years without any health problems, attending the hospital for routine check-ups or accompanying family members. The study will include 70 children diagnosed with T1DM and 70 healthy children, totaling 140 participants. The control group will be age-matched with the study group. Demographic information will be collected after obtaining written and verbal consent from the participants. Motor and sensory assessments of the hand will be conducted and compared.
Tests used for hand sensory, motor, and functional assessment:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Refusal to participate in the study.
- •Parents have not signed a consent form.
- •Not being between the ages of 7-
- •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
结局指标
主要结局
Hand Grip Strength Measurement
时间窗: 1 minute
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.
Jebsen Taylor Hand Function Test (JTEFT)
时间窗: 8 minute
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.
Functional Skills Test
时间窗: 4 minute
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.
Semmes-Weinstein Monofilament Examination
时间窗: 4 minute
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.
Fine Grip Strength Assessment
时间窗: 2 minute
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.
Hot-Cold Assessment
时间窗: 2 minute
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.
Static Two-Point Discrimination Test
时间窗: 2 minute
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.
Vibration Test
时间窗: 4 minute
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.
次要结局
未报告次要终点
研究者
Erdal AYDIN
Principal Investigator
Mustafa Kemal University