Type 2 DiabetesNCT05127291
Dual-Task Effects on Hand Functions in Type 2 Diabetes Mellitus
A study testing Dual-task in people with Type 2 Diabetes, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. It is planned to reach at least 100 participants during the data collection phase of the study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dual-task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2023to 30 Aug 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having been diagnosed with type 2 diabetes mellitus for at least 5 years for study group, having no diagnosed type 2 diabetes mellitus or prediabetes for control group,
- Being able to count down 3 by 3 from a three-digit number,
- Volunteer to take part in the study.
Who cannot join
- History of traumatic or inflammatory injury in the upper extremity,
- History of involving the upper extremity in the last year,
- Having rheumatological/inflammatory arthritis or deformity,
- Having a deformity caused by osteoarthritis in the upper extremity,
- Having a neurological problem affecting the upper extremity,
- Getting 23 points or less on the Mini-Mental Test.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Official title: The Effect of Dual-Task on Hand Functions in Individuals With Type 2 Diabetes Mellitus
The aim of the study is to examine the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. It is planned to reach at least 100 participants during the data collection phase of the study. Demographic information, plasma glucose levels, and HbA1C levels of the participants included in the study will be recorded. The upper extremity problems of the participants will be recorded. Minnesota Manual Dexterity Test will be used to evaluate upper extremity functions.
Read the detailed description
This study is aimed to evaluate the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. The study will conduct in the Internal Medicine Clinic of Kutahya Health Sciences University Evliya Celebi Training and Research Hospital. Approval for the study was granted by the Clinical Research Ethics Committee of Kutahya Health Sciences University and written informed consent forms will be obtained from all the participants. This study is planned to reach at least 50 participants with type 2 diabetes mellitus for the study group and 50 participants without diabetes for the control group. The participants will be questioned about their eligibility for the inclusion criteria. The demographic and descriptive data of the participants will be recorded. Minnesota Manual Dexterity Test will be used to evaluate upper extremity functions. The test will be performed with and without the dual-task. Counting backward from a random three-digit number 3 by 3 will be used for the dual-task. The effect of dual-task will calculate using the difference between the completion time of both tests for both groups.
- Conditions
- Type 2 Diabetes
- Being tested
- Dual-task
- Keywords
- type 2 diabetes, dual-task, hand functions
- 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.
Dual-taskOther
In the study, both groups are going to evaluate with and without dual-task. The dual-task will be counting back down 3 by 3 from a three-digit number.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients with type 2 diabetes mellitus Receives: Other: Dual-task |
| Control Group | Other | People without type 2 diabetes and prediabetes Receives: Other: Dual-task |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Minnesota Dexterity Test
The test consists of two parts, "placing" and "turning". The patient is instructed to put disks to the holes and the test time uses as a score, in the placing test. In the turning test, the patient is instructed to turn the disks before putting the holes. The test time is recorded. The test will perform with and without dual-task and the dual-task effect will calculate.
Measured: 30 minutes
Dual-task effect
Each patient is going to be instructed to perform The Minnesota Dexterity Test with and without dual-task. Firstly, patients are going to perform the two parts of the test without dual-task. Secondly, patients are going to perform two parts of the test while counting down 3 by 3 from a random three-digit number. The percentage of difference is going to calculate as the dual-task effect.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start20 May 2023
- Primary completion20 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Ozge OKUR, Kutahya Health Sciences University
- Investigators
- Eda O Okur, Doctorate, Principal investigator, Kutahya Health Sciences UniversityIsmail Okur, Doctorate, Study director, Kutahya Health Sciences UniversityTurkan Pasali Kilit, Doctorate, Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127291
- Sponsor's protocol ID
- T2DM-Dualtask
- Status last verified
- Sep 2023
- First submitted
- 9 Nov 2021
- Last updated
- 5 Sep 2023
- Results posted
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual-Task on Hand Functions in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05127291
- Acronym / sponsor ID
- T2DM-Dualtask
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, dual-task, hand functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 19 Nov 2021 (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 the study is to examine the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. It is planned to reach at least 100 participants during the data collection phase of the study. Demographic information, plasma glucose levels, and HbA1C levels of the participants included in the study will be recorded. The upper extremity problems of the participants will be recorded. Minnesota Manual Dexterity Test will be used to evaluate upper extremity functions.
Detailed description
This study is aimed to evaluate the effect of dual-task performance on hand functions in individuals with Type 2 Diabetes Mellitus. The study will conduct in the Internal Medicine Clinic of Kutahya Health Sciences University Evliya Celebi Training and Research Hospital. Approval for the study was granted by the Clinical Research Ethics Committee of Kutahya Health Sciences University and written informed consent forms will be obtained from all the participants. This study is planned to reach at least 50 participants with type 2 diabetes mellitus for the study group and 50 participants without diabetes for the control group. The participants will be questioned about their eligibility for the inclusion criteria. The demographic and descriptive data of the participants will be recorded. Minnesota Manual Dexterity Test will be used to evaluate upper extremity functions. The test will be performed with and without the dual-task. Counting backward from a random three-digit number 3 by 3 will be used for the dual-task. The effect of dual-task will calculate using the difference between the completion time of both tests for both groups.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Dual-taskPatients with type 2 diabetes mellitus |
| Control Group | Other | Other: Dual-taskPeople without type 2 diabetes and prediabetes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having been diagnosed with type 2 diabetes mellitus for at least 5 years for study group, having no diagnosed type 2 diabetes mellitus or prediabetes for control group,
- Being able to count down 3 by 3 from a three-digit number,
- Volunteer to take part in the study.
Key exclusion criteria (6 listed)
- History of traumatic or inflammatory injury in the upper extremity,
- History of involving the upper extremity in the last year,
- Having rheumatological/inflammatory arthritis or deformity,
- Having a deformity caused by osteoarthritis in the upper extremity,
- Having a neurological problem affecting the upper extremity,
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 |
|---|---|---|
| Dual-taskIn the study, both groups are going to evaluate with and without dual-task. The dual-task will be counting back down 3 by 3 from a three-digit number. | Other | Control Group, Study Group |
Primary outcome
The Minnesota Dexterity Test
Time frame: 30 minutes
The test consists of two parts, "placing" and "turning". The patient is instructed to put disks to the holes and the test time uses as a score, in the placing test. In the turning test, the patient is instructed to turn the disks before putting the holes. The test time is recorded. The test will perform with and without dual-task and the dual-task effect will calculate.
Dual-task effect
Time frame: 30 minutes
Each patient is going to be instructed to perform The Minnesota Dexterity Test with and without dual-task. Firstly, patients are going to perform the two parts of the test without dual-task. Secondly, patients are going to perform two parts of the test while counting down 3 by 3 from a random three-digit number. The percentage of difference is going to calculate as the dual-task effect.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
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.
Eda O Okur, Doctorate principal investigator
Kutahya Health Sciences University
Ismail Okur, Doctorate study director
Kutahya Health Sciences University
Turkan Pasali Kilit, Doctorate study director
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?
A study testing Dual-task in people with Type 2 Diabetes, 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 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: finished, as of the sponsor's last update on 5 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Minnesota Dexterity Test (time frame: 30 minutes). The study lists 2 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 5 Sep 2023.