Acute StrokeNCT04283760
Investigation of the Reliability and Validity of the Movement Imagination Questionnaire - Revised Second in Acute Stroke Patients
An observational study of Acute Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Our study was planned to investigate the reliability validity of the Movement Imagery Questionnaire- RS in acute stroke patients. For our study, the Turkish version of the Movement Imagery Questionnaire-RS will be established first. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stroke
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2019to Jun 2020
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included 70 stroke patients hospitalized in the Stroke Unit of the Neurology Department of Hacettepe University Hospitals and individuals aged 50-75 years living in Ankara who do not have any disease.
Who may be able to join
- Acute Stroke Patients:
- Ischemic stroke diagnosis by the relevant neurologist,
- At least 24 hours after stroke,
- Stroke for the first time
- Stable vital signs and no improvement in symptoms for 48 hours
- 50 to 75 years of age
Show all 17Show fewer
- 15 points from Glaskow Coma Scale (GCS),
- Absence of apraxia and aphasia (apraxia and aphasia will be evaluated by the relevant neurologist.)
- Being able to walk at least 10 m independently
- A maximum score of 15 from the Beck Depression Inventory
- To score 24 or more from Mini Mental Test
- Signing the Informed Volunteer Consent Form
- Healthy Group:
- Being in the 50-75 age range
- Signing the Informed Volunteer Consent Form
- A maximum score of 15 from the Beck Depression Inventory
- Not having a known neurological disease
Who cannot join
- Supplement for stroke patients; any neurological, orthopedic, psychological (such as schizophrenia, psychosis) and systemic problems for the healthy group
- Use of drugs to affect epilepsy, seizure attacks and cognition
- Cerebellum or mesencephalon lesion
- The presence of contractures or excessive spasticity in the joints to limit movement
- Neglect of a body half
- Irreversible visual (hemianopsia, blindness), presence of auditory disability
- Participate in another experimental or drug study during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe Üniversitesi
Ankara
Fatma N Nurveren, 5355433890 ext. 90, fatmanurveren@gmail.com
About this study
Our study was planned to investigate the reliability validity of the Movement Imagery Questionnaire- RS in acute stroke patients.
For our study, the Turkish version of the Movement Imagery Questionnaire-RS will be established first. Then, the reliability and validity of the questionnaire in acute stroke patients will be examined.
The study included 70 stroke patients hospitalized in the Stroke Unit of the Neurology Department of Hacettepe University Hospitals and individuals between 50-75 years of age who do not have any disease in Ankara.
Read the detailed description
Motor imagery is a cognitive process that the person continues mentally without actually performing a particular motor movement. The concept of motor imaging has become more and more important in recent years and has allowed us to obtain different ideas about the emergence of motor movements. When the literature is analyzed, it was reported that the brain areas activated during the motor movement of individuals overlap with the active areas in the imaging process.As an individual's ability to imagine movement increases, the centers participating in the motor system become so activated. In the literature, it has been stated that this motor imaging ability may decrease in people who have had a stroke. For this reason, the motor imagination ability of the person should be evaluated before a suitable rehabilitation program is decided.When we look at the literature, it was seen that the Movement Imagery Questionnaire - Revised Second was used to evaluate the patients with subacute and chronic stroke, and there was no validity and reliability study in patients with acute stroke. Considering this situation, it was planned to translate the Movement Imagery Questionnaire -RS questionnaire into our language within the scope of our study and then to investigate the reliability and validity of patients with acute stroke.
- Conditions
- Acute Stroke
- Keywords
- acute stroke, motor imagery, visual imagery, kinesthetic imagery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Group | 1. Demographic Information 2. Mental Chronometry Test 3. Movement Imagination Questionnaire- Revised Second 4. Beck Depression Inventory | |
| Acute Stroke Patients | 1. Demographic Information 2. Mental Chronometry Test 3. Movement Imagination Questionnaire- Revised Second 4. Beck Depression Inventory 5. Trail Making Test 6. Barthel Index 7. Motor Assessment Scale 8. Trunk Impairment Scale 9. Mini Mental Test 10. Glaskow Coma Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Imagination Questionnaire - Revised Second
Movement Imagination Questionnaire - Revised Second is a questionnaire used to evaluate motor imaging ability. The Movement Imagination Questionnaire has been revised especially for use in patients with motor function loss such as stroke. The questionnaire has 7 activities in total. Although most of these activities are sitting, there are also activities that must be done during standing. Each action is questioned both visually and kinesthetically and is scored based on the ease of visualization in the range of 0-7 points. Higher scores mean a better outcome.
Measured: about 15 minutes
Secondary outcomes (6)
The Motor Assessment Scale
The Motor Assessment Scale is designed to measure the functional properties of stroke patients. This assessment method evaluates the ability of stroke patients to perform functional tasks. The Motor Assessment Scale consists of eight motor tasks: (1) turning from the supine position, (2) sitting on your back, (3) sitting balance, (4) standing up, (5) walking, (6) upper limb function (7) hand gestures and (8) advanced hand gestures. In addition to these eight engines, the Motor Assessment Scale contains one more item that measures the overall tone. Each item is evaluated on a seven-degree scale from 0 to 6 (optimal motor behavior). The criterion for each degree in the scale corresponds to the description of the activity to be performed. In some cases, the maximum score (6 points) reflects the quality of performance; in others, it corresponds to performance over a period of time.
Measured: about ten minutes
Mental Chronometry Test
Mental chronometry is an objective method used to evaluate motor imagery. It examines the time difference between actually making a movement and imagining the same movement. In general, in healthy individuals, the imagined movement time and movement time are related, but there are studies showing that this time is impaired in stroke patients. In our study, a 10 m walking test will be used to measure mental chronometry. First of all, the patient will be asked to walk 10 m independently and the time will be recorded. He will then be asked to imagine the movement and stop the stopwatch when he begins to imagine and stop himself again when he ends. Time difference and mental chronometry rate will be calculated.
Measured: about one minute
Trail Making Test
Trail Making Test It is used to evaluate individuals' visual scanning speed, managerial functions, visual-motor perception, motor function, planning, organization, abstract thinking and response limitation. The test consists of 2 parts, A and B. In section A, the individual is asked to combine the numbers from 1 to 25 and completion time is recorded. In section B, the individual completes the ordering, corresponding to a number and a letter, respectively, and the completion time is recorded.
Measured: about five minutes
Barthel Index
Barthel Index evaluates the basic activities of daily life in order to determine at what level individuals can independently determine activities such as nutrition, washing, self-care, dressing, bowel care and bladder care, sitting on the toilet, going from bed to wheelchair, using walking / wheelchair and climbing stairs. It is a 10-item scale. The scale has scoring ranging from 0 to 20 or 0 to 100 depending on the daily life activities.
Measured: about 5 minutes
Mental Chronometry Ratio
Real performance time - imagery time/ real performance time
Measured: about one minute
Trunk Impairment Scale
Trunk Impairment Scale is a scale that evaluates post-stroke body disorder. The scale, consisting of 7 parameters, also includes perception of vertical posture, trunk rotation muscle strength and reflexes on the affected and unaffected side, and vertical stop and abdominal manual muscle test sub parameters in Tsuji and colleagues' stroke disorder evaluation set. Each parameter is evaluated over 4 points. The total score ranges from a minimum of 0 to a maximum of 21 points. A higher score means better performance. In this study, only the vertical stop subscale of this scale will be used.
Measured: about one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start11 Sep 2019
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nurveren, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283760
- Sponsor's protocol ID
- GO 19/870
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Butler AJ, Cazeaux J, Fidler A, Jansen J, Lefkove N, Gregg M, Hall C, Easley KA, Shenvi N, Wolf SL. The Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Is a Reliable and Valid Tool for Evaluating Motor Imagery in Stroke Populations. Evid Based Complement Alternat Med. 2012;2012:497289. doi: 10.1155/2012/497289. Epub 2012 Feb 28.
PubMed 22474504Gregg M, Hall C, Butler A. The MIQ-RS: A Suitable Option for Examining Movement Imagery Ability. Evid Based Complement Alternat Med. 2010 Jun;7(2):249-57. doi: 10.1093/ecam/nem170. Epub 2007 Dec 26.
PubMed 18955294Greiner J, Schoenfeld MA, Liepert J. Assessment of mental chronometry (MC) in healthy subjects. Arch Gerontol Geriatr. 2014 Mar-Apr;58(2):226-30. doi: 10.1016/j.archger.2013.09.003. Epub 2013 Oct 18.
PubMed 24275122Malouin F, Pichard L, Bonneau C, Durand A, Corriveau D. Evaluating motor recovery early after stroke: comparison of the Fugl-Meyer Assessment and the Motor Assessment Scale. Arch Phys Med Rehabil. 1994 Nov;75(11):1206-12. doi: 10.1016/0003-9993(94)90006-x.
PubMed 7979930Cangoz B, Karakoc E, Selekler K. Trail Making Test: normative data for Turkish elderly population by age, sex and education. J Neurol Sci. 2009 Aug 15;283(1-2):73-8. doi: 10.1016/j.jns.2009.02.313. Epub 2009 Mar 4.
PubMed 19264326Tsuji T, Liu M, Sonoda S, Domen K, Chino N. The stroke impairment assessment set: its internal consistency and predictive validity. Arch Phys Med Rehabil. 2000 Jul;81(7):863-8. doi: 10.1053/apmr.2000.6275.
PubMed 10895996Fujiwara T, Liu M, Tsuji T, Sonoda S, Mizuno K, Akaboshi K, Hase K, Masakado Y, Chino N. Development of a new measure to assess trunk impairment after stroke (trunk impairment scale): its psychometric properties. Am J Phys Med Rehabil. 2004 Sep;83(9):681-8. doi: 10.1097/01.phm.0000137308.10562.20.
PubMed 15314532Fu C, Jin X, Chen B, Xue F, Niu H, Guo R, Chen Z, Zheng H, Wang L, Zhang Y. Comparison of the Mini-Mental State Examination and Montreal Cognitive Assessment executive subtests in detecting post-stroke cognitive impairment. Geriatr Gerontol Int. 2017 Dec;17(12):2329-2335. doi: 10.1111/ggi.13069. Epub 2017 Jul 4.
PubMed 28675607
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Reliability and Validity of the Movement Imagination Questionnaire - Revised Second in Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT04283760
- Acronym / sponsor ID
- GO 19/870
- Conditions
- Acute Stroke
- Keywords
- acute stroke, motor imagery, visual imagery, kinesthetic imagery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 25 Feb 2020 (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.
Our study was planned to investigate the reliability validity of the Movement Imagery Questionnaire- RS in acute stroke patients.
For our study, the Turkish version of the Movement Imagery Questionnaire-RS will be established first. Then, the reliability and validity of the questionnaire in acute stroke patients will be examined.
The study included 70 stroke patients hospitalized in the Stroke Unit of the Neurology Department of Hacettepe University Hospitals and individuals between 50-75 years of age who do not have any disease in Ankara.
Detailed description
Motor imagery is a cognitive process that the person continues mentally without actually performing a particular motor movement. The concept of motor imaging has become more and more important in recent years and has allowed us to obtain different ideas about the emergence of motor movements. When the literature is analyzed, it was reported that the brain areas activated during the motor movement of individuals overlap with the active areas in the imaging process.As an individual's ability to imagine movement increases, the centers participating in the motor system become so activated. In the literature, it has been stated that this motor imaging ability may decrease in people who have had a stroke. For this reason, the motor imagination ability of the person should be evaluated before a suitable rehabilitation program is decided.When we look at the literature, it was seen that the Movement Imagery Questionnaire - Revised Second was used to evaluate the patients with subacute and chronic stroke, and there was no validity and reliability study in patients with acute stroke. Considering this situation, it was planned to translate the Movement Imagery Questionnaire -RS questionnaire into our language within the scope of our study and then to investigate the reliability and validity of patients with acute stroke.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | – | –1. Demographic Information 2. Mental Chronometry Test 3. Movement Imagination Questionnaire- Revised Second 4. Beck Depression Inventory |
| Acute Stroke Patients | – | –1. Demographic Information 2. Mental Chronometry Test 3. Movement Imagination Questionnaire- Revised Second 4. Beck Depression Inventory 5. Trail Making Test 6. Barthel Index 7. Motor Assessment Scale 8. Trunk Impairment Scale 9. Mini Mental Test 10. Glaskow Coma Scale |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 70 stroke patients hospitalized in the Stroke Unit of the Neurology Department of Hacettepe University Hospitals and individuals aged 50-75 years living in Ankara who do not have any disease.
Key inclusion criteria (17 listed)
- Ischemic stroke diagnosis by the relevant neurologist,
- At least 24 hours after stroke,
- Stroke for the first time
- Stable vital signs and no improvement in symptoms for 48 hours
- 50 to 75 years of age
Key exclusion criteria (7 listed)
- Supplement for stroke patients; any neurological, orthopedic, psychological (such as schizophrenia, psychosis) and systemic problems for the healthy group
- Use of drugs to affect epilepsy, seizure attacks and cognition
- Cerebellum or mesencephalon lesion
- The presence of contractures or excessive spasticity in the joints to limit movement
- Neglect of a body half
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Movement Imagination Questionnaire - Revised Second
Time frame: about 15 minutes
Movement Imagination Questionnaire - Revised Second is a questionnaire used to evaluate motor imaging ability. The Movement Imagination Questionnaire has been revised especially for use in patients with motor function loss such as stroke. The questionnaire has 7 activities in total. Although most of these activities are sitting, there are also activities that must be done during standing. Each action is questioned both visually and kinesthetically and is scored based on the ease of visualization in the range of 0-7 points. Higher scores mean a better outcome.
6 secondary outcomes
The Motor Assessment Scale
Time frame: about ten minutes
Mental Chronometry Test
Time frame: about one minute
Trail Making Test
Time frame: about five minutes
Barthel Index
Time frame: about 5 minutes
Mental Chronometry Ratio
Time frame: about one minute
Trunk Impairment Scale
Time frame: about one minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 22474504Butler AJ, Cazeaux J, Fidler A, Jansen J, Lefkove N, Gregg M, Hall C, Easley KA, Shenvi N, Wolf SL. The Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Is a Reliable and Valid Tool for Evaluating Motor Imagery in Stroke Populations. Evid Based Complement Alternat Med. 2012;2012:497289. doi: 10.1155/2012/497289. Epub 2012 Feb 28.
- Background: PubMed 18955294Gregg M, Hall C, Butler A. The MIQ-RS: A Suitable Option for Examining Movement Imagery Ability. Evid Based Complement Alternat Med. 2010 Jun;7(2):249-57. doi: 10.1093/ecam/nem170. Epub 2007 Dec 26.
- Background: PubMed 24275122Greiner J, Schoenfeld MA, Liepert J. Assessment of mental chronometry (MC) in healthy subjects. Arch Gerontol Geriatr. 2014 Mar-Apr;58(2):226-30. doi: 10.1016/j.archger.2013.09.003. Epub 2013 Oct 18.
- Background: PubMed 7979930Malouin F, Pichard L, Bonneau C, Durand A, Corriveau D. Evaluating motor recovery early after stroke: comparison of the Fugl-Meyer Assessment and the Motor Assessment Scale. Arch Phys Med Rehabil. 1994 Nov;75(11):1206-12. doi: 10.1016/0003-9993(94)90006-x.
- Background: PubMed 19264326Cangoz B, Karakoc E, Selekler K. Trail Making Test: normative data for Turkish elderly population by age, sex and education. J Neurol Sci. 2009 Aug 15;283(1-2):73-8. doi: 10.1016/j.jns.2009.02.313. Epub 2009 Mar 4.
- Background: PubMed 10895996Tsuji T, Liu M, Sonoda S, Domen K, Chino N. The stroke impairment assessment set: its internal consistency and predictive validity. Arch Phys Med Rehabil. 2000 Jul;81(7):863-8. doi: 10.1053/apmr.2000.6275.
- Background: PubMed 15314532Fujiwara T, Liu M, Tsuji T, Sonoda S, Mizuno K, Akaboshi K, Hase K, Masakado Y, Chino N. Development of a new measure to assess trunk impairment after stroke (trunk impairment scale): its psychometric properties. Am J Phys Med Rehabil. 2004 Sep;83(9):681-8. doi: 10.1097/01.phm.0000137308.10562.20.
- Background: PubMed 28675607Fu C, Jin X, Chen B, Xue F, Niu H, Guo R, Chen Z, Zheng H, Wang L, Zhang Y. Comparison of the Mini-Mental State Examination and Montreal Cognitive Assessment executive subtests in detecting post-stroke cognitive impairment. Geriatr Gerontol Int. 2017 Dec;17(12):2329-2335. doi: 10.1111/ggi.13069. Epub 2017 Jul 4.
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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.
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 Acute Stroke, run by Hacettepe 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 17 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: status not confirmed, as of the sponsor's last update on 25 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma N Nurveren (5355433890 ext. +90, fatmanurveren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Imagination Questionnaire - Revised Second (time frame: about 15 minutes). 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 NCT04283760, which also lists 8 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 25 Feb 2020.