Dual-Task Effects on Hand Functions in Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

The Effect of Dual-Task on Hand Functions in Individuals With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127291
• Other study ID #: T2DM-Dualtask
• Status: Completed
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 30, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Dual-task
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.

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes
Primary	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.	30 minutes