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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03635502
Other study ID # IstanbulMU1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 17, 2018
Est. completion date September 30, 2018

Study information

Verified date December 2019
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Bakirköy Dr. Sadi Konuk Training and Research Hospital Istanbul

Sponsors (3)

Lead Sponsor Collaborator
Istanbul Medeniyet University Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 15 min
Primary 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. 20 min
Primary 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. 5 min
Primary 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.
10 min
Secondary 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. 5 min
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