Health, SubjectiveNCT05236244
Motor Imagery in Healthy Individuals
A study testing İntervention group in people with Health, Subjective, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- İntervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Mar 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Health, Subjective
- Being tested
- İntervention group
- Keywords
- motor imagery, mental fatigue, diaphragmatic breathing exercises
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntervention groupOther
Diaphragmatic Breathing Exercises
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | 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 Receives: Other: İntervention group |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
1-Isometric Elbow Flexion Force
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.
Measured: 8 weeks
2-Handgrip strength
2-Handgrip strength: Handgrip strength will be assessed using a Jamar hand dynamometer (Lafayette Instrument Company, USA).
Measured: 8 weeks
3-Upper extremity reaction test
3-Upper extremity reaction test: It is planned to use a validated BlazePod sensor for upper extremity reaction time test
Measured: 8 weeks
4-Finger reaction test
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.
Measured: 8 weeks
5-Hand performance test
5-Hand performance test: A nine-hole peg test will be used.
Measured: 8 weeks
6-Position Sense
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.
Measured: 8 weeks
7-Tactile sense
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).
Measured: 8 weeks
8-Two-point discrimination
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.
Measured: 8 weeks
9-Upper extremity endurance test
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).
Measured: 8 weeks
Secondary outcomes (1)
Mental Fatigue (VAS)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Akçay, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236244
- Sponsor's protocol ID
- BurcinAkcay
- Status last verified
- Oct 2023
- First submitted
- 2 Feb 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Effect of Mental Fatigue Created by Motor Imagery on Upper Extremity Functions Change With Diaphragmatic Breathing Exercises
- ClinicalTrials.gov ID
- NCT05236244
- Acronym / sponsor ID
- BurcinAkcay
- Conditions
- Health, Subjective
- Keywords
- motor imagery, mental fatigue, diaphragmatic breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Feb 2022 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Other: İntervention groupDiaphragmatic 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 |
| Control Group | No intervention | –First Evaluation + (1 week break) + Motor imagery protocol + Second Evaluation + 8 weeks break +Third Evaluation +(1 week interval) + Motor imagery protocol + Fourth Evaluation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| İntervention groupDiaphragmatic Breathing Exercises | Other | İntervention group |
Primary outcome
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.
2-Handgrip strength
Time frame: 8 weeks
2-Handgrip strength: Handgrip strength will be assessed using a Jamar hand dynamometer (Lafayette Instrument Company, USA).
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
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.
5-Hand performance test
Time frame: 8 weeks
5-Hand performance test: A nine-hole peg test will be used.
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.
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-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.
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).
1 secondary outcome
Mental Fatigue (VAS)
Time frame: 8 weeks
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 13 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İntervention group in people with Health, Subjective, run by Bandırma Onyedi Eylül 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 5 inclusion and 7 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 13 Oct 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?
1-Isometric Elbow Flexion Force (time frame: 8 weeks). The study lists 9 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 13 Oct 2023.