Postural Control, Ankle and Trunk Proprioception in Type 2 Diabetes

Sponsor

Hasan Kalyoncu University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06045598

Collaborator

(none)

Enrollment

3.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The investigators aim to assess the postural control, ankle, and trunk proprioception, plantar sensation, and general cognitive status in patients with Type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Type2diabetes	Other: Semmes Weinstein Monofilament Test Other: Proprioception measurement Other: Postural control assessment Other: Dynamic balance assessment Other: Timed Up and Go Test Other: Montreal Cognitive Assessment

Detailed Description

The investigators aim to assess the postural control on different floors with eyes open, eyes closed, and cognitive dual-task, ankle, and trunk proprioception, plantar sensation, and general cognitive status of patients diagnosed with Type 2 diabetes between the ages of 18-65, and to compare them with healthy controls.

Study Design

Study Type:

Observational

Anticipated Enrollment :

62 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Investigation of the Influence of Postural Control, Ankle and Trunk Proprioception in Patients With Type 2 Diabetes

Anticipated Study Start Date :

Sep 10, 2023

Anticipated Primary Completion Date :

Nov 10, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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).	Other: 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. Other: 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. Other: 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. Other: 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. Other: 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. Other: 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	Other: 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. Other: 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. Other: 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. Other: 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. Other: 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. Other: 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.

Arm

Intervention/Treatment

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).

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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

Other: Semmes Weinstein Monofilament Test

Other: Proprioception measurement

Other: Postural control assessment

Other: Dynamic balance assessment

Other: Timed Up and Go Test

Other: Montreal Cognitive Assessment

Outcome Measures

Primary Outcome Measures

Postural Control [20 minutes]
Postural control of the participants will be measured objectively by transferring the data taken from the body to the computer with the help of a wearable sensor using Gyko-Microgate software. Ellipsoid area and moving speed will be measured in mm² and mm/s².
Ankle proprioception [10 minutes]
Proprioception in ankle plantar flexion and dorsiflexion will be measured with the help of a digital goniometer.
Lumbal proprioception [5 minutes]
Proprioception in lumbar flexion and extension will be measured with the help of a digital goniometer.

Secondary Outcome Measures

Plantar sensation [5 minutes]
Semmes-Weinstein Monofilament Test
Cognitive status [10 minutes]
Montreal Cognitive Assessment (MoCA) is evaluated out of 30 points. The highest score that can be obtained from the scale is 30, the lowest score is 0. 21 points is the reference limit and a value below 21 points indicates that there is an affect on cognitive status.
Dynamic Balance [1 minute]
Timed Up and Go Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Be between the ages of 18-65
Volunteering to participate in researc
Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)