- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05236244
Motor Imagery in Healthy Individuals
October 12, 2023 updated by: Burçin Akçay, Bandırma Onyedi Eylül University
Does the Effect of Mental Fatigue Created by Motor Imagery on Upper Extremity Functions Change With Diaphragmatic Breathing Exercises
The research will be the first to examine the relationship between mental fatigue induced by motor imagery and upper extremity performance.
This study, it is aimed to examine whether the effects of mental fatigue created by motor imagery on upper extremity performance can be reduced by diaphragmatic breathing exercises.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Balıkesir, Turkey, 10200
- BandırmaOnyediEylulU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Right-handed dominance (it will be decided according to Edinburgh Hand Questionnaire Result)
- Volunteer to participate in the study.
- To be sedentary
- Not having any problems that prevent breathing exercises
- Be between the ages of 18-30
Exclusion Criteria:
- Have any mental or sensory problems in the past 6 months
- Presence of acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc.
- Having had Covid-19
- Having any respiratory disease (asthma, COPD, etc.)
- Having any upper extremity injury and/or operation (trauma, surgery, fracture, etc.) in the -Last 6 months doing regular exercises (at least 30 minutes a day / 5 times a week for a total of at least 150 minutes)
- Be on regular medication
- Be smoking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: İntervention group
Diaphragmatic breathing exercises: First Evaluation + (1 week break) + Motor imagery protocol + Second Evaluation + 8 weeks of diaphragmatic breathing exercises +Third Evaluation +(1 week interval) + Motor imagery protocol + Fourth Evaluation
|
Diaphragmatic Breathing Exercises
|
|
No Intervention: Control Group
First Evaluation + (1 week break) + Motor imagery protocol + Second Evaluation + 8 weeks break +Third Evaluation +(1 week interval) + Motor imagery protocol + Fourth Evaluation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1-Isometric Elbow Flexion Force
Time Frame: 8 weeks
|
1-Isometric Elbow Flexion Force: The participant will try to move their hands towards their shoulder as forcefully as possible for 2-3 seconds with their upper arms at their sides, elbow bent at 90 degrees and forearm in supination.
|
8 weeks
|
|
2-Handgrip strength
Time Frame: 8 weeks
|
2-Handgrip strength: Handgrip strength will be assessed using a Jamar hand dynamometer (Lafayette Instrument Company, USA).
|
8 weeks
|
|
3-Upper extremity reaction test
Time Frame: 8 weeks
|
3-Upper extremity reaction test: It is planned to use a validated BlazePod sensor for upper extremity reaction time test
|
8 weeks
|
|
4-Finger reaction test
Time Frame: 8 weeks
|
4-Finger reaction test: By placing the dominant hand index finger on the left button of a computer mouse, the participant will be asked to press the left button as soon as the traffic light pattern glows green on the screen.
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8 weeks
|
|
5-Hand performance test
Time Frame: 8 weeks
|
5-Hand performance test: A nine-hole peg test will be used.
|
8 weeks
|
|
6-Position Sense
Time Frame: 8 weeks
|
6-Position Sense: The height of the laser track marker test target board can be adjusted according to the height of the person, and the zero point will be aligned for each patient's glenohumeral joint separately.
A standardized coordinate system drawn on the target board will show the different angles of motion calculated using a formula.
|
8 weeks
|
|
7-Tactile sense
Time Frame: 8 weeks
|
7-Tactile sense: The calibrated Semmes Weinstein monofilament test (North Coast Medical, USA) will be used to measure perceptual thresholds for cutaneous stimuli (Bell-Krotoski, Fess, Figarola, & Hiltz, 1995; Dannenbaum, Michaelsen, Desrosiers, & Levin, 2002).
|
8 weeks
|
|
8-Two-point discrimination
Time Frame: 8 weeks
|
8-Two-point discrimination: The two-point discrimination test is the evaluation of the ability to detect stimuli applied from two different points at the same time.
|
8 weeks
|
|
9-Upper extremity endurance test
Time Frame: 8 weeks
|
9-Upper extremity endurance test: After weighing the body weight, the weight to be held in the hand will be calculated as 2% of the body weight and if it is fractional, it will be rounded to the nearest 0.5 kg.
The participant will hang the test arm out of the bed.
Here he has to take the weight in his hand and raise it so that the "thumb faces up" and the arm is 90° horizontally.
A metronome set to 60 Hz will then be used to standardize the test; in this way, participants will be instructed to raise their arms at the first beep, to keep the arm in 90 abduction during the next beep, and then to lower them to the starting position with the third beep.
The test will be terminated as a result of fulfilling any of the following termination criteria (Moore, Uhl, & Kibler, 2013).
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental Fatigue (VAS)
Time Frame: 8 weeks
|
VAS: In our study, mental fatigue level will be evaluated with VAS.
VAS is a valid and reliable method for measuring the severity of fatigue and is a one-dimensional scale widely used in the clinic.
In practice, patients are asked to choose the number that best describes the severity of fatigue they feel.
Zero means not tired, 10 means very tired.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
February 2, 2022
First Submitted That Met QC Criteria
February 10, 2022
First Posted (Actual)
February 11, 2022
Study Record Updates
Last Update Posted (Actual)
October 13, 2023
Last Update Submitted That Met QC Criteria
October 12, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BurcinAkcay
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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