- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07480122
Motor Imaging, Neglect, and Upper Extremity Function in Stroke
Investigation of the Relationship Between Motor Imagery Skill and Neglect Level, Upper Extremity Motor Function, Activities of Daily Living, and Quality of Life in Individuals After Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is a condition characterized by impaired cerebrovascular circulation due to bleeding or blockage, resulting in problems such as weakness on one side of the body, mobility, balance, coordination, and cognitive impairment. Motor impairment, usually restricting movement of the face, arm, and leg on one side of the body, affects approximately 80% of stroke individuals. Upper extremity function is significantly reduced in about 80% of stroke individuals due to spasticity and muscle weakness, which restricts elbow extension movement. Problems with shoulder, arm, hand, and wrist function-in short, upper extremity disorders-are very common after a stroke. These upper extremity disorders generally involve difficulty with arm, hand, and finger movement and coordination, significantly limiting individuals' interaction with their environment and functionality. In addition to motor losses, spatial neglect due to right hemisphere lesions is one of the frequently observed neuropsychological problems after a stroke. Neglect syndrome is characterized by an individual's inability to perceive, direct attention to, or maintain bodily awareness in the spatial area opposite to the damaged hemisphere of the brain. This negatively impacts motor performance and daily living activities, reducing the effectiveness of rehabilitation. In individuals with severe neglect, the use of the affected side decreases, slowing functional recovery. In recent years, motor cognition-based methods have gained increasing importance in post-stroke rehabilitation alongside classical approaches. One of these methods, motor imagery (MI), is the process of mentally visualizing a movement without actually performing it. Neuroimaging studies have shown that the brain regions activated during motor imagery are largely similar to the motor areas activated during actual movement. Therefore, it is suggested that there may be a relationship between motor functions and motor imagery ability in stroke patients. However, the reported results in this area are inconsistent in stroke patients. Although motor impairments do not directly reflect performance in imagery, motor consequences resulting from brain damage negatively affect imagery, and generally, more severe motor impairments have been associated with weaker imagery ability. Research has shown that individuals with high motor imagery skills experience positive effects in terms of motor performance and learning. Conversely, a decrease in imagery capacity or factors affecting the cognitive representation of movement (e.g., neglect or lateralization disorders) can limit the effectiveness of the rehabilitation process. Therefore, it is important to comprehensively investigate the relationships between motor imagery skills and neglect, upper extremity function, activities of daily living, and quality of life in individuals after a stroke. Based on this information, this study aimed to investigate the relationship between motor imagery skills and the level of neglect (neglet), upper extremity motor function, activities of daily living, quality of life, lateralization performance, and mental rotation ability in individuals after a stroke.
Hypotheses:
- Hypothesis: Motor imagery skills in individuals after a stroke are related to the level of neglect (neglet).
- Hypothesis: Motor imagery skills in individuals after a stroke are related to the level of upper extremity motor function.
- Hypothesis: Motor imagery skills in individuals after a stroke are related to activity of daily living performance.
Hypothesis 4: Motor imagery skills in individuals after stroke are related to their quality of life level.
Hypothesis 5: Motor imagery skills in individuals after stroke are related to lateralization performance.
Hypothesis 6: Motor imagery skills in individuals after stroke are related to mental rotation ability.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: HAVVA ADLI
- Phone Number: 05369831133
- Email: h.adli@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals who have experienced hemiplegia after an ischemic stroke,
- who actively use their right extremity according to the Edinburgh Hand Preference Questionnaire,
- who have right hemisphere involvement,
- who are 18 years of age or older,
- who have been diagnosed with a stroke at least 1 and at most 6 months ago,
- who have middle cerebral artery involvement,
- who have a Standardized Mini Mental Test score of 24 or higher,
- who are Stage 2b or higher according to Eggers staging,
- who can actively control their hand, wrist, and fingers and perform the release reflex,
- who wish to participate in the study voluntarily, and
- who have given their informed consent will be included in the research.
Exclusion Criteria:
- Individuals with major neurological, orthopedic, or rheumatological disorders affecting upper extremity function other than stroke (Polyneuropathy, Parkinson's Disease, Multiple Sclerosis, Rheumatoid Arthritis, etc.),
- Individuals with upper extremity amputation,
- Individuals with uncontrolled arrhythmia, uncontrolled hypertension, or unstable cardiac conditions,
- Individuals with active malignancy and receiving related chemo/radiotherapy,
- Individuals unable to cooperate due to aphasia or cognitive impairment,
- Individuals with visual and hearing problems,
- Individuals with communication problems that would hinder the evaluation and/or implementation of the treatment program,
- Individuals who are unable to undergo mental assessment, complete the scales, or are illiterate will be excluded from the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
stroke group
The study population consists of stroke patients residing in Malatya province, and the sample comprises patients who have presented to a specialist physician with this complaint, received a stroke diagnosis, and applied to our clinic.
Patients will be randomly selected from among those who consulted a physical medicine and rehabilitation specialist, had no contraindications indicated by the physician, agreed to participate voluntarily in the study, and met the study criteria.
They will be evaluated using appropriate assessment methods.
|
No intervention will be made; an assessment will be conducted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Upper Extremity Motor Assessment Scale
Time Frame: 6 mounth
|
Fugl-Meyer and colleagues developed the Fugl-Meyer Motor Assessment Scale in 1975 by expanding on Brunnstrom's motor assessment method.
The scale is a widely used, reliable, and valid test for assessing paretic upper extremity motor impairment in stroke patients.
The FM-UE is a 33-item sub-section of this scale.
The scale evaluates the movement, coordination, and reflexes of the shoulder, elbow, forearm, wrist, and fingers.
Each parameter is scored between 0 and 2 points, with a maximum score of 66, indicating good motor function.
In tests evaluating upper extremity movement, the scoring is as follows: 0: movement cannot be performed, 1: movement is partially performed, and 2: movement is performed normally.
|
6 mounth
|
|
Kinesthetic and Visual Imagination Questionnaire (KVIQ)
Time Frame: 6 mounth
|
The KGIA will be used to evaluate motor imagery skills.
The Turkish validity and reliability study of the scale developed by Malouin et al. was conducted by Dilek et al.
The questionnaire, administered with the assistance of an evaluator, consists of 10 movements and assesses how well participants can visualize and feel the movements.
Participants are first asked to perform the movement actually, and then to visually and kinesthetically imagine the same movement.
The level of visual and kinesthetic imagery is scored between 1 (no image/feeling) and 5 (very clear/very intense), and visual and kinesthetic imagery scores are calculated at the end of the evaluation.
|
6 mounth
|
|
Catherine Bergego Scale
Time Frame: 6 mounth
|
It is a scale that assesses neglect syndrome by directly observing daily life.
The 10-item scale was developed by Professor Philippe Azouvi (1996).
The Turkish validity and reliability study was done by Kulaç et al.
|
6 mounth
|
|
Line Bisection Test
Time Frame: 6 mounth
|
The line-splitting test is one of the tests used in the clinical diagnosis of neglect syndrome.
In this test, patients are presented with a sheet of paper printed on A4 paper, consisting of straight horizontal lines of varying lengths.
These lines are positioned in the center, to the right, and to the left of the paper.
The paper is placed in front of the patient, in the midline.
In this test, the patient is asked to mark the midpoint of all the lines on the paper.
Patients with neglect often mark the right side of the original center.
|
6 mounth
|
|
The Star Cancellation Test
Time Frame: 6 mounth
|
The Star Erase Test was developed in 1987 by Wilson, Cockburn, and Halligan.
It consists of an A4-sized sheet of paper with randomly distributed small stars, large stars, words, and letters.
In the Star Erase Test, there are 52 small stars interspersed among 52 large stars, 10 short words, and 13 letters.
The paper is placed mid-line directly in front of the patient, and the patient is asked to mark the small stars.
The maximum score is 54, as the two middle stars are marked as examples by the observer.
A score of 51 or lower indicates visual inattention.
|
6 mounth
|
|
Wolf Motor Function Test
Time Frame: 6 mounth
|
The WMFT was developed by Wolf et al. to evaluate motor skills in patients with upper extremity motor dysfunction and was later modified by Morris et al. for use in patients with lower motor function.
In this study, the modified WMFT will be used.
The test consists of 17 tasks, including 2 muscle strength items and 15 functional activities.
Functional activities are scored on a 0-5 scale, and the average score represents the functional ability score, with higher scores indicating better motor performance.
Performance time for each task is also recorded, with a maximum time limit of 120 seconds per activity.
Participants are instructed to perform each task as quickly as possible after the command "start.
"
|
6 mounth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lateralization Assessment
Time Frame: 6 mounth
|
Upper extremity right/left lateralization performance will be evaluated using the "Recognise™" application developed by the Neuro-Orthopaedic Institute.
The "Recognise™ Hand" and "Recognise™ Shoulder" sections, specifically the "Vanilla" version of these sections, will be used.
A total of 20 shoulder and 20 hand images will be displayed for 5 seconds, and participants will be asked to press the right or left button on the screen as accurately and quickly as possible, without focusing on their extremity.
Participants will be allowed to practice before the actual assessment.
Accuracy rates and reaction times will be recorded.
|
6 mounth
|
|
Mental Cronometre Time
Time Frame: 6 mounth
|
This will be used to evaluate the chronometric aspect of motor imagery.
A towel folding task will be given for the mental timer.
First, the motor imagery task will be performed.
The time displayed on the screen will be recorded by the observer.
For the physical phase of the test, the same procedure will be performed and the time recorded using a timer.
The mental timer ratio will be calculated.
|
6 mounth
|
|
Stroke-Specific Quality of Life Scale
Time Frame: 6 mounth
|
The Quality of Life Assessment Scale (QQS), developed by Williams et al. in 1999, consists of 49 items covering 12 subcategories (mobility, fitness, upper extremity functionality, work/productivity, mood, self-care, social roles, family roles, language, vision, thinking, and personality) that assess the quality of life of individuals with stroke.
The QQS is a 5-point Likert-type scale; the higher the total score (1=Strongly agree, 2=Partially agree, 3=Neither agree nor disagree, 4=Partially disagree, 5=Disagree), the better the quality of life of the stroke individual.
The Turkish validity and reliability of the scale was established by Hakverdioğlu et al.
|
6 mounth
|
|
Modified Barthel Index
Time Frame: 6 mounth
|
The Daily Living Independence Scale (DLI), used to measure individuals' independence in activities of daily living, is a modification of the Barthel Index.
The DLI includes 10 items related to activities of daily living (eating, personal hygiene, bathing, dressing, bowel and bladder care, toilet use, ambulation, transfers, and stair climbing).
Each item in the DLI has levels from 0 to 5. A different scoring system is used for each activity (for example, the scores for the eating sub-item are 0-2-5-8-10, while the scores for the transfer sub-item are 0-3-8-12-15).
At level 1, the individual is unable to perform the activity, while at level 5, the individual can perform the activity unaided, albeit slowly.
The total score ranges from 0 to 100.
As the score increases, the individual's independence in activities of daily living increases.
The DLI has good reliability and validity.
The Turkish validity and reliability of the scale was established by Küçükdeveci et al.
|
6 mounth
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
- Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007/s00415-011-6247-y. Epub 2011 Oct 1.
- Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
- Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999 Jul;30(7):1362-9. doi: 10.1161/01.str.30.7.1362.
- Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.
- Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.
- Kerkhoff G, Schenk T. Rehabilitation of neglect: an update. Neuropsychologia. 2012 May;50(6):1072-9. doi: 10.1016/j.neuropsychologia.2012.01.024. Epub 2012 Jan 28.
- Dickstein R, Deutsch JE. Motor imagery in physical therapist practice. Phys Ther. 2007 Jul;87(7):942-53. doi: 10.2522/ptj.20060331. Epub 2007 May 1.
- Mulder T. Motor imagery and action observation: cognitive tools for rehabilitation. J Neural Transm (Vienna). 2007;114(10):1265-78. doi: 10.1007/s00702-007-0763-z. Epub 2007 Jun 20.
- Lai SM, Studenski S, Duncan PW, Perera S. Persisting consequences of stroke measured by the Stroke Impact Scale. Stroke. 2002 Jul;33(7):1840-4. doi: 10.1161/01.str.0000019289.15440.f2.
- Candiri B, Talu B, Guner E, Ozen M. The effect of graded motor imagery training on pain, functional performance, motor imagery skills, and kinesiophobia after total knee arthroplasty: randomized controlled trial. Korean J Pain. 2023 Jul 1;36(3):369-381. doi: 10.3344/kjp.23020. Epub 2023 Jun 22.
- Lotze M, Halsband U. Motor imagery. J Physiol Paris. 2006 Jun;99(4-6):386-95. doi: 10.1016/j.jphysparis.2006.03.012. Epub 2006 May 22.
- Momosaki R, Yasunaga H, Kakuda W, Matsui H, Fushimi K, Abo M. Very Early versus Delayed Rehabilitation for Acute Ischemic Stroke Patients with Intravenous Recombinant Tissue Plasminogen Activator: A Nationwide Retrospective Cohort Study. Cerebrovasc Dis. 2016;42(1-2):41-8. doi: 10.1159/000444720. Epub 2016 Mar 18.
- Heilman KM, Valenstein E, Watson RT. Neglect and related disorders. Semin Neurol. 2000;20(4):463-70. doi: 10.1055/s-2000-13179.
- Daprati E, Nico D, Duval S, Lacquaniti F. Different motor imagery modes following brain damage. Cortex. 2010 Sep;46(8):1016-30. doi: 10.1016/j.cortex.2009.08.002. Epub 2009 Aug 13.
- Okuyama K, Ogura M, Kawakami M, Tsujimoto K, Okada K, Miwa K, Takahashi Y, Abe K, Tanabe S, Yamaguchi T, Liu M. Effect of the combination of motor imagery and electrical stimulation on upper extremity motor function in patients with chronic stroke: preliminary results. Ther Adv Neurol Disord. 2018 Oct 9;11:1756286418804785. doi: 10.1177/1756286418804785. eCollection 2018.
- Wang YC, Chang PF, Chen YM, Lee YC, Huang SL, Chen MH, Hsieh CL. Comparison of responsiveness of the Barthel Index and modified Barthel Index in patients with stroke. Disabil Rehabil. 2023 Mar;45(6):1097-1102. doi: 10.1080/09638288.2022.2055166. Epub 2022 Mar 31.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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