- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03635502
What Are the Determinants of Explicit and Implicit Motor Imagery Ability in Stroke Patients?
December 24, 2019 updated by: Esma Nur KOLBAŞI, Istanbul Medeniyet University
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34394
- Bakırköy Dr. Sadi Konuk Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Stroke patients and age, sex, education matched healthy volunteers who meet the inclusion criteria
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy Group
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Stroke Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement Imagery Questionnaire-3 (MIQ-3)
Time Frame: 15 min
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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.
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15 min
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Chaotic Motor Imagery Assessment- Hand Rotation
Time Frame: 20 min
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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.
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20 min
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Box and Block Test
Time Frame: 5 min
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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.
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5 min
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Fugl-Meyer Assessment- Upper Extremity
Time Frame: 10 min
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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:
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10 min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Activity Log-28
Time Frame: 5 min
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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.
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5 min
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2018
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
September 30, 2018
Study Registration Dates
First Submitted
August 14, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
December 27, 2019
Last Update Submitted That Met QC Criteria
December 24, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulMU1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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