Type 2 Diabetes Mellitus (T2DM)NCT06588894
Investigation of Motor Imagery Ability, Body Awareness and Cognitive Functions in Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus (T2DM) and Cognitive Function, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the relationship between motor imagery skills, body awareness and cognitive functions in individuals with Type 2 Diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Cognitive Function, Motor İmagery Ability
- What is being tested?
- Questionnaire and Physical Exam and Motor Imagery Ability
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2024to 10 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals aged 18-65 who have had type 2 DM for at least 5 years
Who may be able to join
- Being a type 2 DM patient between the ages of 18-65 for at least 5 years,
- Being willing to participate in the study,
- Not having any vision, hearing or speech problems that would prevent the tests from being performed.
Who cannot join
- Having previous experience with Motor Imagery techniques or training,
- Having any orthopedic problems that prevent walking,
- Having a history of neurological disease,
- People who are receiving any medication that affects the central nervous system will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya Health Sciences University
Kütahya, Central, 43100
İsmail Okur, PhD, +905552436726, ismail.okur@ksbu.edu.tr
About this study
Official title: Relationship Between Motor Imagery Ability, Body Awareness and Cognitive Functions in Individuals With Type 2 Diabetes Mellitus
The aim of this study is to examine the relationship between motor imagery skills, body awareness and cognitive functions in individuals with Type 2 Diabetes mellitus.
Read the detailed description
Motor imagery can be defined as a voluntary action simulation process that involves focusing intently on the cognitive components of motor tasks. In the literature, motor imagery is seen as a window opening to cognitive motor processes and especially motor control. Motor imagery is negatively affected in many diseases that affect the brain and brain functions, such as stroke, Parkinson, and multiple sclerosis, and motor imagery is frequently used in the rehabilitation of these diseases. Poor glycemic control in Type 2 Diabetes mellitus leads to deterioration in brain and cognitive functions. However, no study has been found on the effects of these disorders seen in Type 2 Diabetes mellitus on MI skills. Motor imagery is a mental practice that is becoming widespread in many areas. However, before considering using Motor imagery-based exercises as a therapy tool for patients, it is important to consider the extent to which patients cognitive impairments are related to their ability to form accurate motor images. For example, studies have found that patients with the lack of body awareness may not be able to produce kinesthetic images of motor movements.
Body awareness is the tendency to pay attention to internal bodily sensations and stimuli and includes the cognitive, emotional, and perceptual abilities that constitute the person general self-awareness. Chronic diseases such as Type 2 Diabetes mellitus affect body awareness and image. Body awareness has been found to be associated with clinical parameters related to diabetes, such as fasting blood sugar and HbA1c levels and duration of diabetes in patients with Type 2 Diabetes mellitus. Changes in body awareness may disrupt the patient self-perception, leading to a poor clinical picture and a poor course of chronic diseases. Therefore, it is important to evaluate possible changes in internal body perception.
To our knowledge, no study has been found in the literature examining the relationship between motor imagery skills of individuals with type 2 diabetes mellitus and body awareness and cognitive functions. The existence of this relationship may guide the use of motor imagery as a treatment method in individuals with Type 2 Diabetes mellitus whose body awareness and cognitive functions are impaired.
Individuals who meet the inclusion criteria will be asked to sign an informed consent form. Then, demographic data of the individuals will be collected using a demographic data form. Individuals; motor imagery skills will be assessed using a mental stopwatch and mental rotation, body awareness will be assessed using the Body Awareness Questionnaire, and cognitive functions will be assessed using the Montreal Cognitive Assessment questionnaire.
- Being tested
- Questionnaire and Physical Exam, Motor Imagery Ability
- Keywords
- cognitive functions, motor imagery ability, type 2 diabetes mellitus
- 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.
Questionnaire and Physical ExamBehavioural
Also called Cognitive Function, Motor imagery Ability, Body Awareness
Individuals motor imagery skills will be assessed using a mental chronometer and mental rotation, body awareness will be assessed using the Body Awareness Questionnaire, and cognitive functions will be assessed using the Montreal Cognitive Assessment questionnaire.
Motor Imagery AbilityBehavioural
Also called Cognitive Function, Body Awareness
Individuals motor imagery skills will be assessed using a mental stopwatch and mental rotation, body awareness will be assessed using the Body Awareness Questionnaire, and cognitive functions will be assessed using theMontreal Cognitive Assessment questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus | 18-65 years old with type 2 DM for at least 5 years Receives: Behavioral: Questionnaire and Physical Exam; Behavioral: Motor Imagery Ability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Chronometer
Mental chronometry provides information about the temporal relationship between real and simulated movements. As part of this assessment, participants will be administered the Nine-Hole Wooden Peg Test. In the study, the patient will be asked to place wooden sticks in the box one by one into the holes on the board as quickly as possible with their dominant hand. They will then be asked to place the sticks back into the box one by one. The total duration of the test will be determined by a chronometer. After the materials are removed from the field of vision, they will be asked to perform this carrying activity using the imagery method and the elapsed time will again be recorded by a chronometer. Motor imagery trials will begin with a countdown of "3-2-1-Start" and will end when participants indicate that they have finished placing by saying "stop".
Measured: 10 minutes
Mental Rotation
Mental rotation provides information about the accuracy of imagined movements. Mental rotation will be evaluated as a hand lateralization task, which is choosing which side the hand belongs to. The test will be applied using the Recognize App Recognize Hand software (Neuro Orthopedic Institute, Adelaide, Australia). Two data will be obtained by performing the test. The first is the percentage of correct responses that are capable of understanding whether the hand images shown belong to the right or the left, and the second is the reaction times of the individuals while performing the task. The "Vanilla" mode will be used for mental rotation ability in the study. This mode consists of images of real human hands in different postures/positions. The patient is given 5 seconds for each hand image and is expected to indicate whether the hand in the image is right or left from the buttons below during this time.
Measured: 10 minutes
Body Awareness
Individuals; body awareness will be measured with the Body Awareness Questionnaire. The Body Awareness Questionnaire consists of 18 questions. Participants will be asked to score each statement between 1 (1: Not true for me at all) and 7 (7: Completely true for me), and the total score is obtained by adding the scores given for each statement. The total score takes a value between 18 and 126. The higher the total score, the better the body awareness.
Measured: 10 minutes
Cognitive Function
Cognitive functions will be assessed with the Montreal Cognitive Assessment (MOCA) questionnaire. MOCA is a screening test that assesses attention and concentration, executive functions, memory, language, visual-spatial abilities, abstract thinking, calculation, and orientation. The total score on the MOCA test ranges from 0 to 30. The cutoff for a normal MOCA score is 26.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Oct 2024
- Primary completion14 Nov 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Okur, Kutahya Health Sciences University
- Investigators
- İsmail Okur, PhD, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588894
- Sponsor's protocol ID
- 2024/03-26
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Motor Imagery Ability, Body Awareness and Cognitive Functions in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06588894
- Acronym / sponsor ID
- 2024/03-26
- Keywords
- cognitive functions, motor imagery ability, type 2 diabetes mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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 aim of this study is to examine the relationship between motor imagery skills, body awareness and cognitive functions in individuals with Type 2 Diabetes mellitus.
Detailed description
Motor imagery can be defined as a voluntary action simulation process that involves focusing intently on the cognitive components of motor tasks. In the literature, motor imagery is seen as a window opening to cognitive motor processes and especially motor control. Motor imagery is negatively affected in many diseases that affect the brain and brain functions, such as stroke, Parkinson, and multiple sclerosis, and motor imagery is frequently used in the rehabilitation of these diseases. Poor glycemic control in Type 2 Diabetes mellitus leads to deterioration in brain and cognitive functions. However, no study has been found on the effects of these disorders seen in Type 2 Diabetes mellitus on MI skills. Motor imagery is a mental practice that is becoming widespread in many areas. However, before considering using Motor imagery-based exercises as a therapy tool for patients, it is important to consider the extent to which patients cognitive impairments are related to their ability to form accurate motor images. For example, studies have found that patients with the lack of body awareness may not be able to produce kinesthetic images of motor movements.
Body awareness is the tendency to pay attention to internal bodily sensations and stimuli and includes the cognitive, emotional, and perceptual abilities that constitute the person general self-awareness. Chronic diseases such as Type 2 Diabetes mellitus affect body awareness and image. Body awareness has been found to be associated with clinical parameters related to diabetes, such as fasting blood sugar and HbA1c levels and duration of diabetes in patients with Type 2 Diabetes mellitus. Changes in body awareness may disrupt the patient self-perception, leading to a poor clinical picture and a poor course of chronic diseases. Therefore, it is important to evaluate possible changes in internal body perception.
To our knowledge, no study has been found in the literature examining the relationship between motor imagery skills of individuals with type 2 diabetes mellitus and body awareness and cognitive functions. The existence of this relationship may guide the use of motor imagery as a treatment method in individuals with Type 2 Diabetes mellitus whose body awareness and cognitive functions are impaired.
Individuals who meet the inclusion criteria will be asked to sign an informed consent form. Then, demographic data of the individuals will be collected using a demographic data form. Individuals; motor imagery skills will be assessed using a mental stopwatch and mental rotation, body awareness will be assessed using the Body Awareness Questionnaire, and cognitive functions will be assessed using the Montreal Cognitive Assessment questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus | – | Behavioral: Questionnaire and Physical Exam, Behavioral: Motor Imagery Ability18-65 years old with type 2 DM for at least 5 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18-65 who have had type 2 DM for at least 5 years
Key inclusion criteria (3 listed)
- Being a type 2 DM patient between the ages of 18-65 for at least 5 years,
- Being willing to participate in the study,
- Not having any vision, hearing or speech problems that would prevent the tests from being performed.
Key exclusion criteria (4 listed)
- Having previous experience with Motor Imagery techniques or training,
- Having any orthopedic problems that prevent walking,
- Having a history of neurological disease,
- People who are receiving any medication that affects the central nervous system will not be included in the study.
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 |
|---|---|---|
| Questionnaire and Physical ExamAlso: Cognitive Function, Motor imagery Ability, Body AwarenessIndividuals motor imagery skills will be assessed using a mental chronometer and mental rotation, body awareness will be assessed using the Body Awareness Questionnaire, and cognitive functions will be assessed using the Montreal Cognitive Assessment questionnaire. | Behavioural | Type 2 Diabetes Mellitus |
| Motor Imagery AbilityAlso: Cognitive Function, Body AwarenessIndividuals motor imagery skills will be assessed using a mental stopwatch and mental rotation, body awareness will be assessed using the Body Awareness Questionnaire, and cognitive functions will be assessed using theMontreal Cognitive Assessment questionnaire. | Behavioural | Type 2 Diabetes Mellitus |
Primary outcome
Mental Chronometer
Time frame: 10 minutes
Mental chronometry provides information about the temporal relationship between real and simulated movements. As part of this assessment, participants will be administered the Nine-Hole Wooden Peg Test. In the study, the patient will be asked to place wooden sticks in the box one by one into the holes on the board as quickly as possible with their dominant hand. They will then be asked to place the sticks back into the box one by one. The total duration of the test will be determined by a chronometer. After the materials are removed from the field of vision, they will be asked to perform this carrying activity using the imagery method and the elapsed time will again be recorded by a chronometer. Motor imagery trials will begin with a countdown of "3-2-1-Start" and will end when participants indicate that they have finished placing by saying "stop".
Mental Rotation
Time frame: 10 minutes
Mental rotation provides information about the accuracy of imagined movements. Mental rotation will be evaluated as a hand lateralization task, which is choosing which side the hand belongs to. The test will be applied using the Recognize App Recognize Hand software (Neuro Orthopedic Institute, Adelaide, Australia). Two data will be obtained by performing the test. The first is the percentage of correct responses that are capable of understanding whether the hand images shown belong to the right or the left, and the second is the reaction times of the individuals while performing the task. The "Vanilla" mode will be used for mental rotation ability in the study. This mode consists of images of real human hands in different postures/positions. The patient is given 5 seconds for each hand image and is expected to indicate whether the hand in the image is right or left from the buttons below during this time.
Body Awareness
Time frame: 10 minutes
Individuals; body awareness will be measured with the Body Awareness Questionnaire. The Body Awareness Questionnaire consists of 18 questions. Participants will be asked to score each statement between 1 (1: Not true for me at all) and 7 (7: Completely true for me), and the total score is obtained by adding the scores given for each statement. The total score takes a value between 18 and 126. The higher the total score, the better the body awareness.
Cognitive Function
Time frame: 20 minutes
Cognitive functions will be assessed with the Montreal Cognitive Assessment (MOCA) questionnaire. MOCA is a screening test that assesses attention and concentration, executive functions, memory, language, visual-spatial abilities, abstract thinking, calculation, and orientation. The total score on the MOCA test ranges from 0 to 30. The cutoff for a normal MOCA score is 26.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
İsmail Okur, PhD principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Cognitive Function, run by Kutahya Health Sciences University at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İsmail Okur, Assit. Prof. (+905552436726, ismail.okur@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Chronometer (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.