StrokeNCT06106542
Muscle Oxygenation in Stroke Patients
An observational study of Stroke, run by Bandırma Onyedi Eylül University.
Trial summary
In addition to its many effects, physical movement is known to change both systemic blood circulation and muscle blood flow. In a study examining the effects of motor imagery, which produces effects similar to physical movement, on muscle oxygenation, no change in muscle oxygenation was detected with motor imagery. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- assessment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2023to 2 Nov 2025
- Phase
- Observational
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals between the ages of 40-75 who are diagnosed with stroke and meet the inclusion criteria who volunteer to participate in the research constitute the sample of the study.
Who may be able to join
- Being between the ages of 40-75
- Being diagnosed with stroke
- BMI <30kg/cm2
- Subcutaneous fat thickness <12mm
- Mini Mental State Test Score being 24 or above
Who cannot join
- Having another musculoskeletal, cardiovascular, pulmonary, metabolic or neurological disease that is serious enough to prevent participation in the study
- Having serious vision and hearing problems
- Presence of serious cognitive impairment determined by the physician that would prevent the tests from being performed
- Presence of an open wound or infection in the area to be measured
About this study
Official title: How Does Motor Imagery Affect Lower Extremity Muscle Oxygenation in Stroke Patients?
In addition to its many effects, physical movement is known to change both systemic blood circulation and muscle blood flow. In a study examining the effects of motor imagery, which produces effects similar to physical movement, on muscle oxygenation, no change in muscle oxygenation was detected with motor imagery. However, no study has been found examining muscle oxygenation along with motor imagery in stroke patients. However, it has not been investigated whether there is a difference in muscle oxygenation between the affected and less affected extremities after stroke. For this reason, our study was planned to examine the effect of motor imagery on lower extremity muscle oxygenation in stroke patients. In addition, in our study, we will examine whether there is a difference in muscle oxygenation between the affected and less affected extremities in stroke patients under different conditions (rest / physical movement / motor imagery (mental movement)). Since there are insufficient studies in this field in the literature, we think that our study will lead to future studies.
- Conditions
- Stroke
- Being tested
- assessment
- Keywords
- motor imagery, Muscle oxygenation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
assessment of motor imagery on muscle oxygenation
| Study group | Role | What they receive |
|---|---|---|
| stroke group | assessment of effect motor imagery on muscle oxygenation Receives: Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle oxygenation
Muscle oxygenation measurement with Moxy muscle oxygen monitor via quadriceps femoris muscle in both affected and less affected extremities
Measured: baseline
Kinesthetic and Visual Imagery Questionnaire
It is a tool used to evaluate the imagination levels of healthy and physically disabled individuals. There are a total of 20 items in the survey, 10 visual and 10 kinesthetic. With the questionnaire, the intensity level of imagery is recorded on a 5-point Likert scale. A high score is considered an indication of a good level of visualization.
Measured: baseline
Movement imagery questionnaire 3
The survey consists of 12 items. With the questionnaire, the intensity level of imagery is recorded on a 7-point Likert scale. A high score is considered an indication of a good level of visualization.
Measured: baseline
Mental Stopwatch/ Mental Chronometer
Mental stopwatch is a method that allows objective measurement of motor imagery by examining the time difference between the physical execution of the movement (Movement Execution Time, MET) and the mental visualization of the same movement (Movement Imagery Time, MIT). A stopwatch will be kept at the beginning of the visualization and the stopwatch will be stopped when the individual says that he/she has finished visualizing the test. The physically realized time will be compared with the imagined time. It will be used with the Timed Up and Go Test.
Measured: baseline
Timed Up and Go Test
This test evaluates the dynamic balance of individuals during functional mobility; It includes components such as standing, walking and turning. Individuals are asked to stand up from the chair they are sitting on without support, and after walking a distance of 3 meters, they are asked to return from the designated area and sit on the chair again without support. At the end of the test, the time calculated with a stopwatch is noted in seconds.
Measured: baseline
Five Times Sit to Stand Test
The individual was asked to stand up and sit down five times without holding on to the chair, and the time taken was recorded. This method, which is valid and reliable in stroke patients, has been shown to be related to lower extremity muscle strength and balance. Low times are indicative of high performance.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start2 Nov 2023 (estimated)
- Primary completion2 Nov 2024 (estimated)
- Study completion2 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra KESKİN, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106542
- Sponsor's protocol ID
- 2023-126
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Motor Imagery Affect Lower Extremity Muscle Oxygenation in Stroke Patients?
- ClinicalTrials.gov ID
- NCT06106542
- Acronym / sponsor ID
- 2023-126
- Conditions
- Stroke
- Keywords
- motor imagery, Muscle oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 2 Nov 2023 (estimated)
- Primary completion
- 2 Nov 2024 (estimated)
- Study completion
- 2 Nov 2025 (estimated)
- First posted
- 30 Oct 2023 (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.
In addition to its many effects, physical movement is known to change both systemic blood circulation and muscle blood flow. In a study examining the effects of motor imagery, which produces effects similar to physical movement, on muscle oxygenation, no change in muscle oxygenation was detected with motor imagery. However, no study has been found examining muscle oxygenation along with motor imagery in stroke patients. However, it has not been investigated whether there is a difference in muscle oxygenation between the affected and less affected extremities after stroke. For this reason, our study was planned to examine the effect of motor imagery on lower extremity muscle oxygenation in stroke patients. In addition, in our study, we will examine whether there is a difference in muscle oxygenation between the affected and less affected extremities in stroke patients under different conditions (rest / physical movement / motor imagery (mental movement)). Since there are insufficient studies in this field in the literature, we think that our study will lead to future studies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke group | – | Other: assessmentassessment of effect motor imagery on muscle oxygenation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals between the ages of 40-75 who are diagnosed with stroke and meet the inclusion criteria who volunteer to participate in the research constitute the sample of the study.
Key inclusion criteria (5 listed)
- Being between the ages of 40-75
- Being diagnosed with stroke
- BMI <30kg/cm2
- Subcutaneous fat thickness <12mm
- Mini Mental State Test Score being 24 or above
Key exclusion criteria (4 listed)
- Having another musculoskeletal, cardiovascular, pulmonary, metabolic or neurological disease that is serious enough to prevent participation in the study
- Having serious vision and hearing problems
- Presence of serious cognitive impairment determined by the physician that would prevent the tests from being performed
- Presence of an open wound or infection in the area to be measured
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 |
|---|---|---|
| assessmentassessment of motor imagery on muscle oxygenation | Other | stroke group |
Primary outcome
muscle oxygenation
Time frame: baseline
Muscle oxygenation measurement with Moxy muscle oxygen monitor via quadriceps femoris muscle in both affected and less affected extremities
Kinesthetic and Visual Imagery Questionnaire
Time frame: baseline
It is a tool used to evaluate the imagination levels of healthy and physically disabled individuals. There are a total of 20 items in the survey, 10 visual and 10 kinesthetic. With the questionnaire, the intensity level of imagery is recorded on a 5-point Likert scale. A high score is considered an indication of a good level of visualization.
Movement imagery questionnaire 3
Time frame: baseline
The survey consists of 12 items. With the questionnaire, the intensity level of imagery is recorded on a 7-point Likert scale. A high score is considered an indication of a good level of visualization.
Mental Stopwatch/ Mental Chronometer
Time frame: baseline
Mental stopwatch is a method that allows objective measurement of motor imagery by examining the time difference between the physical execution of the movement (Movement Execution Time, MET) and the mental visualization of the same movement (Movement Imagery Time, MIT). A stopwatch will be kept at the beginning of the visualization and the stopwatch will be stopped when the individual says that he/she has finished visualizing the test. The physically realized time will be compared with the imagined time. It will be used with the Timed Up and Go Test.
Timed Up and Go Test
Time frame: baseline
This test evaluates the dynamic balance of individuals during functional mobility; It includes components such as standing, walking and turning. Individuals are asked to stand up from the chair they are sitting on without support, and after walking a distance of 3 meters, they are asked to return from the designated area and sit on the chair again without support. At the end of the test, the time calculated with a stopwatch is noted in seconds.
Five Times Sit to Stand Test
Time frame: baseline
The individual was asked to stand up and sit down five times without holding on to the chair, and the time taken was recorded. This method, which is valid and reliable in stroke patients, has been shown to be related to lower extremity muscle strength and balance. Low times are indicative of high performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Bandırma Onyedi Eylül University.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
muscle oxygenation (time frame: baseline). The study lists 6 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 30 Oct 2023.