Postural Control, Ankle and Trunk Proprioception in Type 2 Diabetes
NCT ID: NCT06045598
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
62 participants
OBSERVATIONAL
2023-09-10
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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type 2 diabetes group
Participants between the ages of 18-65 who have been diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA).
Semmes Weinstein Monofilament Test
The 10 g Semmes-Weinstein monofilament assessment (SWME) is used to assess sensory loss and screen for diabetic neuropathy. In our study, the evaluation will be made on the plantar surfaces of the 1st fingers, the plantar surfaces of the 1st, 3rd, and 5th metatarsal heads, and the plantar surfaces of the heel in the right and left feet. The first force value felt will be taken as the evaluation data.
Proprioception measurement
Ankle proprioception will be measured with the participant's knees lying on their back in a semi-flexed position. The test will be performed for 10 degrees of dorsiflexion and 20 degrees of plantar flexion, respectively. Measurements will be made with an electrogoniometer device. The difference between the required degree and the degree in the position brought by the participant will be taken as evaluation data.
Lumbal region proprioception measurement will be made with lumbar flexion and extension movements. The participant will be asked to perform active lumbar flexion. Then, lumbar flexion movement will be performed up to 50% of the measured active flexion angle and it will be requested to stay in this position for 10 seconds. After the participant returns to the upright position, he will be asked to come back to the learned angle and the difference in angle will be taken as evaluation data. The same procedure will be done for the lumbar extension movement.
Postural control assessment
Postural control evaluation will be done with the Gyko-Microgate software. Bluetooth data transmission enables real-time measurements to be transferred directly to the computer. After the device was placed on the body of the person thanks to the wearable vest, a connection was established with the software on the computer.
To evaluate postural control, with eyes open, eyes closed and eyes open on a hard surface, accompanied by a cognitive dual task; On soft ground, with eyes open, eyes closed and eyes open, the person is asked to remain in a stable balance for 30 seconds, accompanied by a cognitive dual task. For the cognitive dual task, two countdowns and K-A-S verbal fluency exercises will be performed in each assessment. As a result of each evaluation, data on ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be obtained.
Dynamic balance assessment
Dynamic balance evaluation will be done with the Gyko device. To evaluate dynamic balance, walking with eyes open on hard ground, walking with cognitive dual task on hard ground; walking with eyes open on soft ground, and cognitive dual task on soft ground will be evaluated. The walking distance is determined as 6 meters. The first 1 meter and the last 1 meter will not be taken into consideration. The measurement will start at the 1st meter and end at the 5th meter. The measurement will be carried out at a distance of 4 meters. As a cognitive task, the participants will be given the task of counting down by two and K-A-S verbal fluency. As a result of each evaluation, data on the ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be obtained.
Timed Up and Go Test
The Timed Get Up and Walk Test is used to assess balance and fall risk. The participant stands up from the chair, walks 3 meters, turns back, and sits back on the chair. The time elapsed during these phases was recorded.
In our study, the patient will be asked to start the test after the Gyko device is fixed with a wearable vest. During the test, data on the ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be taken.
Montreal Cognitive Assessment
MoCA is a 10-minute scale that measures global cognitive skills. It includes items consisting of attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation and orientation skills. The lowest score that can be obtained from the scale is 0, and the highest score is 30. Scores of 21 and below indicate the presence of cognitive impairment.
control group
Healthy participants between the ages of 18-65 who have not been diagnosed with Type 2 diabetes
Semmes Weinstein Monofilament Test
The 10 g Semmes-Weinstein monofilament assessment (SWME) is used to assess sensory loss and screen for diabetic neuropathy. In our study, the evaluation will be made on the plantar surfaces of the 1st fingers, the plantar surfaces of the 1st, 3rd, and 5th metatarsal heads, and the plantar surfaces of the heel in the right and left feet. The first force value felt will be taken as the evaluation data.
Proprioception measurement
Ankle proprioception will be measured with the participant's knees lying on their back in a semi-flexed position. The test will be performed for 10 degrees of dorsiflexion and 20 degrees of plantar flexion, respectively. Measurements will be made with an electrogoniometer device. The difference between the required degree and the degree in the position brought by the participant will be taken as evaluation data.
Lumbal region proprioception measurement will be made with lumbar flexion and extension movements. The participant will be asked to perform active lumbar flexion. Then, lumbar flexion movement will be performed up to 50% of the measured active flexion angle and it will be requested to stay in this position for 10 seconds. After the participant returns to the upright position, he will be asked to come back to the learned angle and the difference in angle will be taken as evaluation data. The same procedure will be done for the lumbar extension movement.
Postural control assessment
Postural control evaluation will be done with the Gyko-Microgate software. Bluetooth data transmission enables real-time measurements to be transferred directly to the computer. After the device was placed on the body of the person thanks to the wearable vest, a connection was established with the software on the computer.
To evaluate postural control, with eyes open, eyes closed and eyes open on a hard surface, accompanied by a cognitive dual task; On soft ground, with eyes open, eyes closed and eyes open, the person is asked to remain in a stable balance for 30 seconds, accompanied by a cognitive dual task. For the cognitive dual task, two countdowns and K-A-S verbal fluency exercises will be performed in each assessment. As a result of each evaluation, data on ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be obtained.
Dynamic balance assessment
Dynamic balance evaluation will be done with the Gyko device. To evaluate dynamic balance, walking with eyes open on hard ground, walking with cognitive dual task on hard ground; walking with eyes open on soft ground, and cognitive dual task on soft ground will be evaluated. The walking distance is determined as 6 meters. The first 1 meter and the last 1 meter will not be taken into consideration. The measurement will start at the 1st meter and end at the 5th meter. The measurement will be carried out at a distance of 4 meters. As a cognitive task, the participants will be given the task of counting down by two and K-A-S verbal fluency. As a result of each evaluation, data on the ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be obtained.
Timed Up and Go Test
The Timed Get Up and Walk Test is used to assess balance and fall risk. The participant stands up from the chair, walks 3 meters, turns back, and sits back on the chair. The time elapsed during these phases was recorded.
In our study, the patient will be asked to start the test after the Gyko device is fixed with a wearable vest. During the test, data on the ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be taken.
Montreal Cognitive Assessment
MoCA is a 10-minute scale that measures global cognitive skills. It includes items consisting of attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation and orientation skills. The lowest score that can be obtained from the scale is 0, and the highest score is 30. Scores of 21 and below indicate the presence of cognitive impairment.
Interventions
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Semmes Weinstein Monofilament Test
The 10 g Semmes-Weinstein monofilament assessment (SWME) is used to assess sensory loss and screen for diabetic neuropathy. In our study, the evaluation will be made on the plantar surfaces of the 1st fingers, the plantar surfaces of the 1st, 3rd, and 5th metatarsal heads, and the plantar surfaces of the heel in the right and left feet. The first force value felt will be taken as the evaluation data.
Proprioception measurement
Ankle proprioception will be measured with the participant's knees lying on their back in a semi-flexed position. The test will be performed for 10 degrees of dorsiflexion and 20 degrees of plantar flexion, respectively. Measurements will be made with an electrogoniometer device. The difference between the required degree and the degree in the position brought by the participant will be taken as evaluation data.
Lumbal region proprioception measurement will be made with lumbar flexion and extension movements. The participant will be asked to perform active lumbar flexion. Then, lumbar flexion movement will be performed up to 50% of the measured active flexion angle and it will be requested to stay in this position for 10 seconds. After the participant returns to the upright position, he will be asked to come back to the learned angle and the difference in angle will be taken as evaluation data. The same procedure will be done for the lumbar extension movement.
Postural control assessment
Postural control evaluation will be done with the Gyko-Microgate software. Bluetooth data transmission enables real-time measurements to be transferred directly to the computer. After the device was placed on the body of the person thanks to the wearable vest, a connection was established with the software on the computer.
To evaluate postural control, with eyes open, eyes closed and eyes open on a hard surface, accompanied by a cognitive dual task; On soft ground, with eyes open, eyes closed and eyes open, the person is asked to remain in a stable balance for 30 seconds, accompanied by a cognitive dual task. For the cognitive dual task, two countdowns and K-A-S verbal fluency exercises will be performed in each assessment. As a result of each evaluation, data on ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be obtained.
Dynamic balance assessment
Dynamic balance evaluation will be done with the Gyko device. To evaluate dynamic balance, walking with eyes open on hard ground, walking with cognitive dual task on hard ground; walking with eyes open on soft ground, and cognitive dual task on soft ground will be evaluated. The walking distance is determined as 6 meters. The first 1 meter and the last 1 meter will not be taken into consideration. The measurement will start at the 1st meter and end at the 5th meter. The measurement will be carried out at a distance of 4 meters. As a cognitive task, the participants will be given the task of counting down by two and K-A-S verbal fluency. As a result of each evaluation, data on the ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be obtained.
Timed Up and Go Test
The Timed Get Up and Walk Test is used to assess balance and fall risk. The participant stands up from the chair, walks 3 meters, turns back, and sits back on the chair. The time elapsed during these phases was recorded.
In our study, the patient will be asked to start the test after the Gyko device is fixed with a wearable vest. During the test, data on the ellipsoid area, anteroposterior velocity, anteroposterior distance, mediolateral velocity, and mediolateral distance will be taken.
Montreal Cognitive Assessment
MoCA is a 10-minute scale that measures global cognitive skills. It includes items consisting of attention and concentration, executive functions, memory, language, visuospatial skills, abstract thinking, calculation and orientation skills. The lowest score that can be obtained from the scale is 0, and the highest score is 30. Scores of 21 and below indicate the presence of cognitive impairment.
Eligibility Criteria
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Inclusion Criteria
* Volunteering to participate in researc
* Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)
Exclusion Criteria
* Traumatic nerve injury
* Presence of congenital anomaly in the upper extremity
* Presence of systematic disease (eg: rheumatological)
* Having a problem involving the neurological system
* Surgery involving the upper extremity in the last 6 months
18 Years
65 Years
ALL
No
Sponsors
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Hasan Kalyoncu University
OTHER
Responsible Party
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Günseli Usgu
Principal Investigator
Locations
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Hasan Kalyoncu University
Gaziantep, , Turkey (Türkiye)
Hasan Kalyoncu University
Gaziantep, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Gorniak SL, Lu FY, Lee BC, Massman PJ, Wang J. Cognitive impairment and postural control deficit in adults with Type 2 diabetes. Diabetes Metab Res Rev. 2019 Feb;35(2):e3089. doi: 10.1002/dmrr.3089. Epub 2018 Nov 8.
Other Identifiers
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HKU 2023
Identifier Type: -
Identifier Source: org_study_id
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