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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dual-task
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes focused on measuring type 2 diabetes, dual-task, hand functions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kutahya Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study Group

Control Group

Arm Description

Patients with type 2 diabetes mellitus

People without type 2 diabetes and prediabetes

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2021
Last Updated
September 1, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05127291
Brief Title
Dual-Task Effects on Hand Functions in Type 2 Diabetes Mellitus
Official Title
The Effect of Dual-Task on Hand Functions in Individuals With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, dual-task, hand functions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Patients with type 2 diabetes mellitus
Arm Title
Control Group
Arm Type
Other
Arm Description
People without type 2 diabetes and prediabetes
Intervention Type
Other
Intervention Name(s)
Dual-task
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Minnesota Dexterity Test
Description
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.
Time Frame
30 minutes
Title
Dual-task effect
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eda O Okur, Doctorate
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ismail Okur, Doctorate
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Turkan Pasali Kilit, Doctorate
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Study Director
Facility Information:
Facility Name
Kutahya Health Sciences University
City
Kutahya
ZIP/Postal Code
43100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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