StrokeNCT04832334
Investigation Of The Relationship Between Imagery Ability, Balance And Functionality After Stroke
An observational study of Stroke and Motor İmagery Ability, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to determine the relationship between post-stroke imagination ability, balance, and functionality, and to compare the motor imagery skills of those who had stroke with compatible healthy individuals. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Motor İmagery Ability, Mental Chronometry
- What is being tested?
- Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test., Berg Balance Scale, Functional Reach Test and Timed Up and Go Test, Functional Independence Scale
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2021to 20 Sep 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this study, we will enroll patients based on the statistics of the articles titled "Motor imagery in stroke patients or plegic patients with spinal cord or peripheral diseases" and "Effects of a single mental chronometry training session in subacute stroke patients - a randomized controlled trial". We calculated the power analysis from this article. According to this calculated; α=0.05, 1-β=0.90, effect size=0.96. Stroke patients treated at Istanbul Medipol University Pendik Hospital Physical Medicine and Rehabilitation Clinic Neurology Rehabilitation Unit and healthy individuals matching them will be included.
Who may be able to join
- Post-stroke hemiplegia or chronic hemiparesis
- Not having any neurological disorder other than stroke
- Not having vision problems that will affect the materials to be used during the treatment.
- To be able to communicate enough to understand the orders given
- Standardized Mini Mental Test (SMMT) score of 24 and above
- Not having seen a visualization application before
- Being between the ages of 40-80
- To be similar in terms of age, gender, education level of individuals with stroke
Who cannot join
- Having an advanced degree of aphasia
- Unilateral neglect
- Standardized Mini Mental Test (SMMT) score below 24 points
- Multiple stroke history
- Having pain and limitation of joint motion that will interfere with functional activity
- Walking restriction
Show all 9Show fewer
- Serious communication or understanding problems
- Presence of serious cardiovascular, respiratory, metabolic or orthopedic problems
- Presence of a secondary neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There a Relationship Between Imagination Ability, Balance and Functionality After Stroke?
It was aimed to determine the relationship between post-stroke imagination ability, balance, and functionality, and to compare the motor imagery skills of those who had stroke with compatible healthy individuals.
Read the detailed description
İn the study, 20 individuals with hemiplegic or chronic hemiparesis who agreed to participate by signing the voluntary consent form, who meet the inclusion criteria, and 20 healthy individuals who are similar in terms of age, gender and education level will be included.
The individuals included in the study will be divided into two groups:
Group 1: Stroke Patients Group 2: Control Group
- Conditions
- Stroke, Motor İmagery Ability, Mental Chronometry, Balance, Functionality
- Being tested
- Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test., Berg Balance Scale, Functional Reach Test, Timed Up and Go Test, Functional Independence Scale
- Keywords
- stroke, motor imagery, mental chronometry, balance, functionality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test.Other
Imagery ability was determined.
Berg Balance Scale, Functional Reach TestOther
Balance level was determined.
Timed Up and Go Test, Functional Independence ScaleOther
Functionality was evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Participants | Stroke patients with hemiplegia or chronic hemiparesis Receives: Other: Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test.; Other: Berg Balance Scale, Functional Reach Test; Other: Timed Up and Go Test, Functional Independence Scale | |
| Healthy Participants | The healthy control group was matched with stroke participants in terms of age, gender, dominant side and education level. Receives: Other: Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test.; Other: Berg Balance Scale, Functional Reach Test; Other: Timed Up and Go Test, Functional Independence Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl - Meyer Motor Recovery Assessment Form
It will only be evaluated in the stroke group. It is a scale that evaluates sensorimotor recovery after stroke. Each parameter was scored as 0 points: unsuccessful, 1 point: partially successful, 2 points: completely successful performance on the scale, which includes 50 items specific to stroke and based on performance. The maximum score that can be taken for the upper extremity in the scale where voluntary movement, reflex activity, grip, coordination and speed are evaluated is 66 and 34 for the lower extremity.
Measured: Day 0
Mini-Mental State Test
It was used to determine the cognitive state. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points. The ideal threshold value of the Mini-Mental State Test was found to be 24.
Measured: Day 0
Clock Drawing Test
It will be used to assess the phenomenon of neglect of the stroke individual. The individual is asked to draw a clock circle and insert the numbers of the clock into it. After finishing the numbers, the hands of the clock are placed to show 11 to 10 past.
Measured: Day 0
Digit Span Test
This test to evaluate the ability to sustain attention is a subtest of the Wechsler Adult Intelligence Scale--Revised battery. The test consists of two parts as forward and reverse range. In both parts, random numbers are read to the person at one second intervals, the numbers increase with each attempt and the person is asked to repeat in the same way. In both episodes, the number of digits of the previous sequence in which the person failed twice in a row constitutes the range. The maximum score that can be obtained for each section is 7, and a total of 14 points for the whole test.
Measured: Day 0
Kinesthetic and Visual Imaging Questionnaire
The Kinesthetic and Visual Imaging Questionnaire has been developed to evaluate the imagination ability in individuals with physical disabilities. The purpose of the questionnaire is to determine to what extent individuals visualize and feel the movements they imagine.
Measured: Day 0
Box and Block Test
It is a highly sensitive test for changes in upper extremity functional performance. However, this study will be used for evaluating mental chronometry ability rather than functional performance.
Measured: Day 0
Functional Independence Scale
It is a scale used to evaluate the motor and cognitive competence of patients in daily life activities. Scale; It consists of 18 items that evaluate six functions: self-care, sphincter control, transfer, displacement, communication, and social perception. Each item is scored between 1 (activity fully dependent) and 7 (activity fully independent) in proportion to the amount of assistance received. A minimum of 18 and a maximum of 126 points can be obtained. A low score means that the level of addiction has increased.
Measured: Day 0
Berg Balance Scale
It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully. The total score of the test is between 0-56.0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.
Measured: Day 0
Time Up and Go Test
The test measures the speed during many functional maneuvers such as standing up, walking, turning, and sitting. In the test, the person is asked to stand up from the chair, walk 3 meters (10 feet) at a safe and normal pace, turn, walk back and sit on the chair, and the time is recorded in seconds. A short performance period indicates a good balance performance.
Measured: Day 0
Functional Reach Test
Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1). The placement of the end of the third metacarpal along the yardstick will recorded. Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded. No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated.
Measured: Day 0
Hand Lateralization Test
It requires participants to question the laterality of the hand images presented and is commonly used to measure motor imagination ability in humans. It is used to evaluate implicit motor imagination ability. It is also a test that evaluates mental rotation, another dimension of imagination.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start20 Mar 2021
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İkbal Tunç, Medipol University
- Investigators
- Fatma Mutluay, Professor, Study director, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832334
- Sponsor's protocol ID
- Medipol Hospital 21
- Status last verified
- Nov 2021
- First submitted
- 1 Apr 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share individual participant data.
Publications
Cho HY, Kim JS, Lee GC. Effects of motor imagery training on balance and gait abilities in post-stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Aug;27(8):675-80. doi: 10.1177/0269215512464702. Epub 2012 Nov 5.
PubMed 23129815Amesz S, Tessari A, Ottoboni G, Marsden J. An observational study of implicit motor imagery using laterality recognition of the hand after stroke. Brain Inj. 2016;30(8):999-1004. doi: 10.3109/02699052.2016.1147600. Epub 2016 Jun 13.
PubMed 27294678Liepert J, Greiner J, Nedelko V, Dettmers C. Reduced upper limb sensation impairs mental chronometry for motor imagery after stroke: clinical and electrophysiological findings. Neurorehabil Neural Repair. 2012 Jun;26(5):470-8. doi: 10.1177/1545968311425924. Epub 2012 Jan 13.
PubMed 22247502Morioka S, Osumi M, Nishi Y, Ishigaki T, Ishibashi R, Sakauchi T, Takamura Y, Nobusako S. Motor-imagery ability and function of hemiplegic upper limb in stroke patients. Ann Clin Transl Neurol. 2019 Feb 17;6(3):596-604. doi: 10.1002/acn3.739. eCollection 2019 Mar.
PubMed 30911582Sharma N, Pomeroy VM, Baron JC. Motor imagery: a backdoor to the motor system after stroke? Stroke. 2006 Jul;37(7):1941-52. doi: 10.1161/01.STR.0000226902.43357.fc. Epub 2006 Jun 1.
PubMed 16741183
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Relationship Between Imagination Ability, Balance and Functionality After Stroke?
- ClinicalTrials.gov ID
- NCT04832334
- Acronym / sponsor ID
- Medipol Hospital 21
- Conditions
- Stroke, Motor İmagery Ability, Mental Chronometry, Balance, Functionality
- Keywords
- stroke, motor imagery, mental chronometry, balance, functionality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 5 Apr 2021 (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.
It was aimed to determine the relationship between post-stroke imagination ability, balance, and functionality, and to compare the motor imagery skills of those who had stroke with compatible healthy individuals.
Detailed description
İn the study, 20 individuals with hemiplegic or chronic hemiparesis who agreed to participate by signing the voluntary consent form, who meet the inclusion criteria, and 20 healthy individuals who are similar in terms of age, gender and education level will be included.
The individuals included in the study will be divided into two groups:
Group 1: Stroke Patients Group 2: Control Group
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Participants | – | Other: Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test., Other: Berg Balance Scale, Functional Reach Test, Other: Timed Up and Go Test, Functional Independence ScaleStroke patients with hemiplegia or chronic hemiparesis |
| Healthy Participants | – | Other: Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test., Other: Berg Balance Scale, Functional Reach Test, Other: Timed Up and Go Test, Functional Independence ScaleThe healthy control group was matched with stroke participants in terms of age, gender, dominant side and education level. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, we will enroll patients based on the statistics of the articles titled "Motor imagery in stroke patients or plegic patients with spinal cord or peripheral diseases" and "Effects of a single mental chronometry training session in subacute stroke patients - a randomized controlled trial". We calculated the power analysis from this article. According to this calculated; α=0.05, 1-β=0.90, effect size=0.96. Stroke patients treated at Istanbul Medipol University Pendik Hospital Physical Medicine and Rehabilitation Clinic Neurology Rehabilitation Unit and healthy individuals matching them will be included.
Key inclusion criteria (8 listed)
- Post-stroke hemiplegia or chronic hemiparesis
- Not having any neurological disorder other than stroke
- Not having vision problems that will affect the materials to be used during the treatment.
- To be able to communicate enough to understand the orders given
- Standardized Mini Mental Test (SMMT) score of 24 and above
Key exclusion criteria (9 listed)
- Having an advanced degree of aphasia
- Unilateral neglect
- Standardized Mini Mental Test (SMMT) score below 24 points
- Multiple stroke history
- Having pain and limitation of joint motion that will interfere with functional activity
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 |
|---|---|---|
| Kinesthetic and Visual Imagery Questionnaire, Box and Block Test, Hand Lateralization Test.Imagery ability was determined. | Other | Healthy Participants, Stroke Participants |
| Berg Balance Scale, Functional Reach TestBalance level was determined. | Other | Healthy Participants, Stroke Participants |
| Timed Up and Go Test, Functional Independence ScaleFunctionality was evaluated. | Other | Healthy Participants, Stroke Participants |
Primary outcome
Fugl - Meyer Motor Recovery Assessment Form
Time frame: Day 0
It will only be evaluated in the stroke group. It is a scale that evaluates sensorimotor recovery after stroke. Each parameter was scored as 0 points: unsuccessful, 1 point: partially successful, 2 points: completely successful performance on the scale, which includes 50 items specific to stroke and based on performance. The maximum score that can be taken for the upper extremity in the scale where voluntary movement, reflex activity, grip, coordination and speed are evaluated is 66 and 34 for the lower extremity.
Mini-Mental State Test
Time frame: Day 0
It was used to determine the cognitive state. The Mini-Mental State Test was first published by Folstein et al. It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points. The ideal threshold value of the Mini-Mental State Test was found to be 24.
Clock Drawing Test
Time frame: Day 0
It will be used to assess the phenomenon of neglect of the stroke individual. The individual is asked to draw a clock circle and insert the numbers of the clock into it. After finishing the numbers, the hands of the clock are placed to show 11 to 10 past.
Digit Span Test
Time frame: Day 0
This test to evaluate the ability to sustain attention is a subtest of the Wechsler Adult Intelligence Scale--Revised battery. The test consists of two parts as forward and reverse range. In both parts, random numbers are read to the person at one second intervals, the numbers increase with each attempt and the person is asked to repeat in the same way. In both episodes, the number of digits of the previous sequence in which the person failed twice in a row constitutes the range. The maximum score that can be obtained for each section is 7, and a total of 14 points for the whole test.
Kinesthetic and Visual Imaging Questionnaire
Time frame: Day 0
The Kinesthetic and Visual Imaging Questionnaire has been developed to evaluate the imagination ability in individuals with physical disabilities. The purpose of the questionnaire is to determine to what extent individuals visualize and feel the movements they imagine.
Box and Block Test
Time frame: Day 0
It is a highly sensitive test for changes in upper extremity functional performance. However, this study will be used for evaluating mental chronometry ability rather than functional performance.
Functional Independence Scale
Time frame: Day 0
It is a scale used to evaluate the motor and cognitive competence of patients in daily life activities. Scale; It consists of 18 items that evaluate six functions: self-care, sphincter control, transfer, displacement, communication, and social perception. Each item is scored between 1 (activity fully dependent) and 7 (activity fully independent) in proportion to the amount of assistance received. A minimum of 18 and a maximum of 126 points can be obtained. A low score means that the level of addiction has increased.
Berg Balance Scale
Time frame: Day 0
It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully. The total score of the test is between 0-56.0-20 points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.
Time Up and Go Test
Time frame: Day 0
The test measures the speed during many functional maneuvers such as standing up, walking, turning, and sitting. In the test, the person is asked to stand up from the chair, walk 3 meters (10 feet) at a safe and normal pace, turn, walk back and sit on the chair, and the time is recorded in seconds. A short performance period indicates a good balance performance.
Functional Reach Test
Time frame: Day 0
Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1). The placement of the end of the third metacarpal along the yardstick will recorded. Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded. No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated.
Hand Lateralization Test
Time frame: Day 0
It requires participants to question the laterality of the hand images presented and is commonly used to measure motor imagination ability in humans. It is used to evaluate implicit motor imagination ability. It is also a test that evaluates mental rotation, another dimension of imagination.
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 10 Dec 2021.
- Background: PubMed 23129815Cho HY, Kim JS, Lee GC. Effects of motor imagery training on balance and gait abilities in post-stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Aug;27(8):675-80. doi: 10.1177/0269215512464702. Epub 2012 Nov 5.
- Background: PubMed 27294678Amesz S, Tessari A, Ottoboni G, Marsden J. An observational study of implicit motor imagery using laterality recognition of the hand after stroke. Brain Inj. 2016;30(8):999-1004. doi: 10.3109/02699052.2016.1147600. Epub 2016 Jun 13.
- Background: PubMed 22247502Liepert J, Greiner J, Nedelko V, Dettmers C. Reduced upper limb sensation impairs mental chronometry for motor imagery after stroke: clinical and electrophysiological findings. Neurorehabil Neural Repair. 2012 Jun;26(5):470-8. doi: 10.1177/1545968311425924. Epub 2012 Jan 13.
- Background: PubMed 30911582Morioka S, Osumi M, Nishi Y, Ishigaki T, Ishibashi R, Sakauchi T, Takamura Y, Nobusako S. Motor-imagery ability and function of hemiplegic upper limb in stroke patients. Ann Clin Transl Neurol. 2019 Feb 17;6(3):596-604. doi: 10.1002/acn3.739. eCollection 2019 Mar.
- Background: PubMed 16741183Sharma N, Pomeroy VM, Baron JC. Motor imagery: a backdoor to the motor system after stroke? Stroke. 2006 Jul;37(7):1941-52. doi: 10.1161/01.STR.0000226902.43357.fc. Epub 2006 Jun 1.
- Individual participant dataSharing planned: No. We will not plan to share individual participant data.
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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.
Fatma Mutluay, Professor study director
İstanbul Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Motor İmagery Ability, run by Medipol 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 8 inclusion and 9 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 10 Dec 2021. 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?
Fugl - Meyer Motor Recovery Assessment Form (time frame: Day 0). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832334, which also lists 5 linked publications.
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 10 Dec 2021.