StrokeNCT03635502
What Are the Determinants of Explicit and Implicit Motor Imagery Ability in Stroke Patients?
An observational study of Stroke and Healthy, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Motor imagery (MI) might be described as a dynamic process in which an individual mentally stimulates an action without any overt movement. After stroke, motor imagery ability is impaired and also due to structure of MI, not every stroke patients is able to perform MI. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2018to 30 Sep 2018
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients and age, sex, education matched healthy volunteers who meet the inclusion criteria
Who may be able to join
- Being between the ages of 18-80,
- Having a unilateral stroke for the first time and 0-6 months since stroke onset
- 24 points and above in Mini Mental State Examination (MMDM)
- Not having a disease that may interfere with the study such as cardiac diseases, orthopedic conditions,etc.
Who cannot join
- Multiple strokes
- Sever cognitive dysfunction (<24 points in MMDM)
- Unilateral neglect
- Upper extremity pain that interferes with the study or aggravated with movement
- Visual problems, aphasia or another sequel that might limit the assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34394
About this study
Official title: What Are the Determinants of Explicit and Implicit Motor Imagery Ability in Stroke Patients?: A Controlled Study
Motor imagery (MI) might be described as a dynamic process in which an individual mentally stimulates an action without any overt movement. After stroke, motor imagery ability is impaired and also due to structure of MI, not every stroke patients is able to perform MI. Therefore, the aim of the study is a) to compare both explicit and implicit motor imagery ability (MIA) between patients with stroke and healthy subjects, b) to examine predictive effects of clinical characteristics for MIA after stroke.
- 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 |
|---|---|---|
| Stroke Group | Not described | |
| Healthy Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Imagery Questionnaire-3 (MIQ-3)
MIQ-3 evaluates an individual's motor imagery ability in 3 subscales: 1. internal imagery, 2. external imagery, 3. kinesthetic imagery. Each of these scales ranges from 1 to 7 where 1 indicates very hard to see/feel (image) and 7 indicates very easy to see/feel. 12 items are included in the MIQ-3 and every item is scored according to the scales. The higher the score in subscales, the better the results are.
Measured: 15 min
Chaotic Motor Imagery Assessment- Hand Rotation
Hand Rotation is the first component of Chaotic Motor Imagery Assessment. In this measure, 96 drawings of each hand (left and right) from 4 different plane and at 12 different angle are presented to the individuals and then, it is asked to decide whether it is left or right hand. Total test time, total accuracy, total wrong answers, right accuracy, left accuracy, impaired hand and non-impaired hand accuracy is recorded as outcome scores.
Measured: 20 min
Box and Block Test
Box and Block Test is used to calculate mental chronometry (MC) ratio. During the test, patients are asked to carry 15 blocks first physically and then mentally from one box to another. As outcome scores, the time required to carry 15 blocks physically (MET) and mentally (MIT) are recorded. Then MC ratio is calculated with the formula: (MET-MIT)/ MET.
Measured: 5 min
Fugl-Meyer Assessment- Upper Extremity
Upper extremity part of Fugl Meyer Assessment (FMAUE) is used to evaluate patients' motor impairment level. Total motor and sensory scores are recorded. Then, patients are divided into 4 different categories according to their motor impairment level:
- 23-31 points: poor upper extremity function,
- 32-47 points: limited function,
- 48-52 points: notable function, 4.53-66 points: full function.
Measured: 10 min
Secondary outcomes (1)
Motor Activity Log-28
Turkish version of MAL-28 was used to assess how much (amount of use scale) and how well (how well scale) the patients used their upper extremity in daily life after stroke. These 2 different scales are calculated separately with range of 0-5 points.The higher the points are, the better the patients' situation.
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start17 Aug 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Responsible party
- Principal investigator, Esma Nur KOLBAŞI, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635502
- Sponsor's protocol ID
- IstanbulMU1
- Status last verified
- Dec 2019
- First submitted
- 14 Aug 2018
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Determinants of Explicit and Implicit Motor Imagery Ability in Stroke Patients?: A Controlled Study
- ClinicalTrials.gov ID
- NCT03635502
- Acronym / sponsor ID
- IstanbulMU1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Istanbul University, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 17 Aug 2018 (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.
Motor imagery (MI) might be described as a dynamic process in which an individual mentally stimulates an action without any overt movement. After stroke, motor imagery ability is impaired and also due to structure of MI, not every stroke patients is able to perform MI. Therefore, the aim of the study is a) to compare both explicit and implicit motor imagery ability (MIA) between patients with stroke and healthy subjects, b) to examine predictive effects of clinical characteristics for MIA after stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Group | – | – |
| Healthy Group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients and age, sex, education matched healthy volunteers who meet the inclusion criteria
Key inclusion criteria (4 listed)
- Being between the ages of 18-80,
- Having a unilateral stroke for the first time and 0-6 months since stroke onset
- 24 points and above in Mini Mental State Examination (MMDM)
- Not having a disease that may interfere with the study such as cardiac diseases, orthopedic conditions,etc.
Key exclusion criteria (5 listed)
- Multiple strokes
- Sever cognitive dysfunction (<24 points in MMDM)
- Unilateral neglect
- Upper extremity pain that interferes with the study or aggravated with movement
- Visual problems, aphasia or another sequel that might limit the assessment
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 Imagery Questionnaire-3 (MIQ-3)
Time frame: 15 min
MIQ-3 evaluates an individual's motor imagery ability in 3 subscales: 1. internal imagery, 2. external imagery, 3. kinesthetic imagery. Each of these scales ranges from 1 to 7 where 1 indicates very hard to see/feel (image) and 7 indicates very easy to see/feel. 12 items are included in the MIQ-3 and every item is scored according to the scales. The higher the score in subscales, the better the results are.
Chaotic Motor Imagery Assessment- Hand Rotation
Time frame: 20 min
Hand Rotation is the first component of Chaotic Motor Imagery Assessment. In this measure, 96 drawings of each hand (left and right) from 4 different plane and at 12 different angle are presented to the individuals and then, it is asked to decide whether it is left or right hand. Total test time, total accuracy, total wrong answers, right accuracy, left accuracy, impaired hand and non-impaired hand accuracy is recorded as outcome scores.
Box and Block Test
Time frame: 5 min
Box and Block Test is used to calculate mental chronometry (MC) ratio. During the test, patients are asked to carry 15 blocks first physically and then mentally from one box to another. As outcome scores, the time required to carry 15 blocks physically (MET) and mentally (MIT) are recorded. Then MC ratio is calculated with the formula: (MET-MIT)/ MET.
Fugl-Meyer Assessment- Upper Extremity
Time frame: 10 min
Upper extremity part of Fugl Meyer Assessment (FMAUE) is used to evaluate patients' motor impairment level. Total motor and sensory scores are recorded. Then, patients are divided into 4 different categories according to their motor impairment level: 1. 23-31 points: poor upper extremity function, 2. 32-47 points: limited function, 3. 48-52 points: notable function, 4.53-66 points: full function.
1 secondary outcome
Motor Activity Log-28
Time frame: 5 min
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 27 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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?
An observational study of Stroke and Healthy, run by Istanbul Medeniyet 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 4 inclusion and 5 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 27 Dec 2019. 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?
Movement Imagery Questionnaire-3 (MIQ-3) (time frame: 15 min). The study lists 4 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 27 Dec 2019.