Type2diabetesNCT06045598
Postural Control, Ankle and Trunk Proprioception in Type 2 Diabetes
An observational study of Type2diabetes, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Semmes Weinstein Monofilament Test, Proprioception measurement and Dynamic balance assessment
- How many people
- 62 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Sep 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Hasan Kalyoncu University
Gaziantep, 27000
Günseli Usgu, Ass. Prof., gunseli.usgu@hku.edu.tr
- Recruiting
Hasan Kalyoncu University
Gaziantep, 27000
About this study
Official title: Investigation of the Influence of Postural Control, Ankle and Trunk Proprioception in Patients With Type 2 Diabetes
The investigators aim to assess the postural control, ankle, and trunk proprioception, plantar sensation, and general cognitive status in patients with Type 2 diabetes.
Read the 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.
- Conditions
- Type2diabetes
- Being tested
- Semmes Weinstein Monofilament Test, Proprioception measurement, Postural control assessment, Dynamic balance assessment, Timed Up and Go Test
- Keywords
- type 2 diabetes, postural control, proprioception, sensation, cognition
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semmes Weinstein Monofilament TestOther
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 measurementOther
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 assessmentOther
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 assessmentOther
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 TestOther
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 AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 | |
| control group | Healthy participants between the ages of 18-65 who have not been diagnosed with Type 2 diabetes Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Ankle proprioception
Proprioception in ankle plantar flexion and dorsiflexion will be measured with the help of a digital goniometer.
Measured: 10 minutes
Lumbal proprioception
Proprioception in lumbar flexion and extension will be measured with the help of a digital goniometer.
Measured: 5 minutes
Secondary outcomes (3)
Plantar sensation
Semmes-Weinstein Monofilament Test
Measured: 5 minutes
Cognitive status
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.
Measured: 10 minutes
Dynamic Balance
Timed Up and Go Test
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start10 Sep 2023
- Primary completion10 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Günseli Usgu, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045598
- Sponsor's protocol ID
- HKU 2023
- Status last verified
- Oct 2023
- First submitted
- 23 Aug 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30338902
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Influence of Postural Control, Ankle and Trunk Proprioception in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06045598
- Acronym / sponsor ID
- HKU 2023
- Conditions
- Type2diabetes
- Keywords
- type 2 diabetes, postural control, proprioception, sensation, cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to assess the postural control, ankle, and trunk proprioception, plantar sensation, and general cognitive status in patients with Type 2 diabetes.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes group | – | 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 AssessmentParticipants 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 | – | 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 AssessmentHealthy participants between the ages of 18-65 who have not been diagnosed with Type 2 diabetes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semmes Weinstein Monofilament TestThe 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 | control group, type 2 diabetes group |
| Proprioception measurementAnkle 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 | control group, type 2 diabetes group |
| Postural control assessmentPostural 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 | control group, type 2 diabetes group |
| Dynamic balance assessmentDynamic 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 | control group, type 2 diabetes group |
| Timed Up and Go TestThe 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 | control group, type 2 diabetes group |
| Montreal Cognitive AssessmentMoCA 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. | Other | control group, type 2 diabetes group |
Primary outcome
Postural Control
Time frame: 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
Time frame: 10 minutes
Proprioception in ankle plantar flexion and dorsiflexion will be measured with the help of a digital goniometer.
Lumbal proprioception
Time frame: 5 minutes
Proprioception in lumbar flexion and extension will be measured with the help of a digital goniometer.
3 secondary outcomes
Plantar sensation
Time frame: 5 minutes
Cognitive status
Time frame: 10 minutes
Dynamic Balance
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 30338902Gorniak 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2diabetes, run by Hasan Kalyoncu University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gunseli Usgu, Dr. (+905308845472, gunseli.usgu@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Control (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06045598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.