Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06206317 |
| Other study ID # |
erdalaydin.T1DM |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2024 |
| Est. completion date |
June 3, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Mustafa Kemal University |
| Contact |
Erdal AYDIN |
| Phone |
+905456208598 |
| Email |
fzt.erdalaydin[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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:
*Jebsen Taylor Hand Function Test (JTEFT) is a standardized test developed by Jebsen et al.
in 1969, comprising seven sub-tests to evaluate hand functions objectively. The test
demonstrates high reliability and validity, with reference values prepared for different age
groups and genders.
The sub-tests include:
1. Writing a sentence (24 words) ("The Weather Will Be Cloudy With Rain")
2. Flipping 5 cards: (3x5 inches in size)
3. Small object retrieval and placing them into a tin box (2 paper clips, 2 coins, and 2
soda caps)
4. Using a dessert spoon to pick up 5 dried kidney beans (nutrition simulation)
5. Stacking backgammon stones (using a wooden backgammon piece)
6. Throwing 5 lightweight tin cans across a distance
7. Throwing 5 heavy tin cans (450g) across a distance The test is time-limited, with a time
limit given for each sub-test. The time taken by the child to complete each sub-test is
recorded in seconds. A shorter completion time indicates better performance. To ensure
standardization, a scaled board among the test materials and a stopwatch for timing the
activities are used. The chair and table used during the test should be of appropriate
size for the child. Before administering the test, the child is instructed and shown how
to perform the tasks. Explaining that the test is time-limited is necessary for the
child's motivation. The child starts with a "begin" command, and when the child finishes
the activity, the stopwatch is stopped. The time taken to complete each activity for
both the dominant and non-dominant hand is recorded in seconds for scoring.
- Functional Dexterity Test (FDT) provides information about fine motor skills in
children. The examiner places a pegboard (a square board with 16 holes measuring
20.6 cm in one side) on the edge of a table where the child is seated. The
researcher instructs the child to flip each peg (a wooden piece with one black and
one red side) over. Starting from the farthest peg from the tested hand, the pegs
are flipped in a zigzag pattern and then placed back onto the pegboard. The
researcher uses a stopwatch to calculate the time taken to flip all pegs and
records it in seconds. At the end of the study, two scores are obtained: the time
taken to complete the test in seconds and the completion rate (rate = number of
flipped pegs / seconds). Normative values for FDT are available for children aged 3
to 17.
- Hand grip strength will be evaluated using a jamar Hydraulic Hand Dynamometer in
the standardized test position established by the American Society of Hand
Therapists. During measurement, the children will be positioned in a chair without
back support, sitting upright. Measurements will be taken with the shoulder in
adduction, the elbow at 90 degrees of flexion, the forearm in a neutral position,
and the wrist in 0-30 degrees of extension and 0-15 degrees of ulnar deviation.
Three measurements of muscle strength will be taken for both the right and left
hands, and the average values will be recorded in kilograms. A 1-minute rest period
will be given between each test.
- Baseline® pinch gauge will be used for evaluating fine pinch grip strength.
Measurements will be performed in the position defined by the American Society of
Hand Therapists (the child sitting in a position without back support, with the
shoulder in adduction, and the forearm and wrist in a neutral position). The child
will be positioned so that the hips and knees are flexed at a 90° angle. Three
measurements will be taken for each type of grip (lateral, palmar, and tip-to-tip).
In the lateral grip, the midpoint of the thumb's distal phalanx is placed against
the middle radial aspect of the index finger. In the palmar grip, the distal palmar
surface of the thumb is placed against the distal palmar surfaces of the second and
third fingers. In the tip-to-tip grip, the distal interphalangeal and proximal
interphalangeal joints of the thumb and index finger are flexed, and their distal
ends are brought together. The child will be instructed to exert the maximum force
possible on the gauge for each grip position, followed by relaxation after each
measurement. After three measurements in each position, a 15-second rest period
will be given before testing the other hand. The results will be recorded in
kilograms, and their average values will be calculated.
- Semmes-Weinstein monofilaments (SWM) with values ranging from 1.65 to 6.65 will be
used for evaluating light touch/pressure sensation. Three points will be tested in
the areas innervated by the median and ulnar nerves: for the median nerve, the 1st
fingertip, 2nd fingertip, and proximal phalanx of the 2nd finger; for the ulnar
nerve, the 5th fingertip, proximal phalanx of the 5th finger, and proximal
hypothenar area will be tested. The assessment starts with the lightest
monofilament and progresses until the patient feels the monofilament. The tip of
the monofilament is applied to the predetermined points for 1.5 seconds. Three
assessments will be conducted, and at least 2 correct responses are required. If
this condition cannot be met, the value of the monofilament used will be
considered. The classification for SWM test results is as follows: 1.65-2.83
(green), normal sensation; 3.22-3.61 (blue), decreased light touch sensation;
3.84-4.31 (purple), decreased protective sensation; 4.56-6.65 (red), loss of
protective sensation.
- The static two-point discrimination test will be conducted using a discriminator.
The two ends of the discriminator will be adjusted to a distance of 5 mm, and the
child will be asked to indicate whether they feel one or two points. The
discriminator will apply equal pressure to both ends simultaneously with a slight
touch. Each test point will be touched three times with the discriminator. The
distance where the child reports feeling one or cannot differentiate in two out of
three tests will be recorded as the child's two-point discrimination score. The
values obtained from the four test points will be added together and divided by
four to calculate the average value.
- Vibration sensation will be assessed using a 128 Hz tuning fork. During
measurement, the child will be positioned in a chair without back support, sitting
upright. The assessment will be performed with the shoulder in adduction, the elbow
at 90 degrees of flexion, and the forearm in a neutral position while the child's
eyes are closed. The assessment will be conducted on the second metacarpal head,
the fifth metacarpal head, and the fingertip of the index finger. The duration of
vibration sensation felt by the patient will be recorded using a stopwatch.
- For the hot-cold assessment, two tubes containing hot and cold water, respectively,
will be used. The temperature of the hot water will be set at 45 degrees Celsius,
and the cold water at 25 degrees Celsius. To eliminate visual cues, the individual
will be asked to look in a different direction. After contacting the dermatome area
with the tubes, the person will be asked which tube contains hot or cold water.
Scoring will be as follows: 1 point if the person correctly identifies the tubes
and 0 points if they answer incorrectly.
Hypotheses of this study:
H0: There is no significant difference in the motor and sensory functions of the hand between
children diagnosed with Type 1 Diabetes Mellitus and their healthy peers.
H1: There is a significant difference in the motor and sensory functions of the hand between
children diagnosed with Type 1 Diabetes Mellitus and their healthy peers.
