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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04283760
Other study ID # GO 19/870
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 11, 2019
Est. completion date June 2020

Study information

Verified date February 2020
Source Hacettepe University
Contact Fatma N Nurveren
Phone 5355433890
Email fatmanurveren@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria:

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

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe Üniversitesi Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

Cangoz 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. — View Citation

Fu 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. — View Citation

Fujiwara 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. — View Citation

Gregg 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. — View Citation

Greiner 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. — View Citation

Malouin 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. — View Citation

Tsuji 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. about 15 minutes
Secondary 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. about ten minutes
Secondary 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. about one minute
Secondary 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. about five minutes
Secondary 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. about 5 minutes
Secondary Mental Chronometry Ratio Real performance time - imagery time/ real performance time about one minute
Secondary 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. about one minute
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