Postural Control, Ankle and Trunk Proprioception in Type 2 Diabetes
Investigation of the Influence of Postural Control, Ankle and Trunk Proprioception in Patients With Type 2 Diabetes
1 other identifier
observational
62
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2023
CompletedStudy Start
First participant enrolled
September 10, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 23, 2023
October 1, 2023
2 months
August 23, 2023
October 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Postural Control
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.
20 minutes
Ankle proprioception
Proprioception in ankle plantar flexion and dorsiflexion will be measured with the help of a digital goniometer.
10 minutes
Lumbal proprioception
Proprioception in lumbar flexion and extension will be measured with the help of a digital goniometer.
5 minutes
Secondary Outcomes (3)
Plantar sensation
5 minutes
Cognitive status
10 minutes
Dynamic Balance
1 minute
Study Arms (2)
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).
control group
Healthy participants between the ages of 18-65 who have not been diagnosed with Type 2 diabetes
Interventions
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.
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 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 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.
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.
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
31 patients between the ages of 18-65 who were diagnosed with Type 2 diabetes and 31 healthy participants who were not diagnosed with Type 2 diabetes, who applied to Hasan Kalyoncu University Application and Research Center, will participate in the study. All participants will be given detailed information about the study and signed a written informed consent form stating that they have voluntarily accepted the study.
You may qualify if:
- 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)
You may not qualify if:
- Insufficient cognitive level
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hasan Kalyoncu University
Gaziantep, 27000, Turkey (Türkiye)
Hasan Kalyoncu University
Gaziantep, 27000, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 30338902BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 23, 2023
First Posted
September 21, 2023
Study Start
September 10, 2023
Primary Completion
November 10, 2023
Study Completion
December 31, 2023
Last Updated
October 23, 2023
Record last verified: 2023-10