NCT06588894

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress73%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2026

Expected
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

September 5, 2024

Last Update Submit

March 9, 2026

Conditions

Keywords

cognitive functionsmotor imagery abilitytype 2 diabetes mellitus

Outcome Measures

Primary Outcomes (4)

  • 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".

    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.

    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.

    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.

    20 minutes

Study Arms (1)

Type 2 Diabetes Mellitus

18-65 years old with type 2 DM for at least 5 years

Behavioral: Questionnaire and Physical ExamBehavioral: Motor Imagery Ability

Interventions

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.

Also known as: Cognitive Function, Motor imagery Ability, Body Awareness
Type 2 Diabetes Mellitus

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.

Also known as: Cognitive Function, Body Awareness
Type 2 Diabetes Mellitus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals aged 18-65 who have had type 2 DM for at least 5 years

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Central, 43100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Surveys and QuestionnairesRestraint, PhysicalNeuropsychological Tests

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilizationPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • İsmail Okur, PhD

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İsmail Okur, Assit. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

October 14, 2024

Primary Completion (Estimated)

November 14, 2026

Study Completion (Estimated)

December 10, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations