- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06326749
Effectiveness of Modified Graded Motor Imagery Training in Stroke Patients
Investigation of the Effect of Modified Graded Motor Imagery Training on Upper Extremity Motor Function, Activities of Daily Living, Quality of Life and Motor Imagery Skills in Stroke Patients
Study Overview
Status
Detailed Description
At study is planned as a combination of action observation training, motor imagery and graded motor imagery training, which have come to the fore in recent years and whose importance increases with each passing year. Additionally, its preferability in treatment will be investigated by comparing it with Graded Motor Imagery training, in which the standard protocol is applied. It is anticipated that treatment protocols will shed light on future studies.
The hypotheses of the study are as follows:
Hypothesis 1: Modified Graded Motor Imagery training is more effective than Graded Motor Imagery training and conventional treatment in improving upper extremity motor functions in individuals with stroke.
Hypothesis 2: Modified Graded Motor Imagery training is more effective than Graded Motor Imagery training and conventional treatment in improving daily living activities in individuals with stroke.
Hypothesis 3: Modified Graded Motor Imagery training is more effective than Graded Motor Imagery training and conventional treatment in improving the quality of life in individuals with stroke.
Hypothesis 4: Modified Graded Motor Imagery training is more effective than Graded Motor Imagery training and conventional treatment in improving motor imagery skills in individuals with stroke. Design of the study: The study was designed as a randomized controlled study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye), 44280
- Inonu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Hemiplegia was observed after CVO, According to the Edinburgh Handedness Questionnaire, those who actively use their right extremity, Those with right hemisphere involvement, Those aged 18 and over, Having been diagnosed with stroke at least 1 month ago and at most 6 months ago, Middle cerebral artery involvement, Having a Standardized Mini Mental Test score of 24 or above, having a Stage 2b or above according to Eggers staging, Able to actively control hands, wrists and fingers and perform the release reflex Those who want to participate in the study voluntarily and Individuals with informed consent will be included in the study.
Exclusion Criteria:
Those with major neurological, orthopedic or rheumatological disorders that affect upper extremity function other than stroke (Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.).
Those with upper extremity amputation, Uncontrolled arrhythmia, uncontrolled hypertension, unstable cardiac status Active malignancy and receiving chemo/radiotherapy related to it Uncooperative due to aphasia or cognitive impairment Individuals with vision and hearing problems Having a communication problem that may prevent implementation of the evaluations and/or treatment program Individuals who do not allow mental evaluation, cannot fill out the scales, and are illiterate will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Modified Graded Motor Imagery and Conventional Treatment Group:
The modified DMI program consists of 4 stages: lateralization, open motor imagery including action observation training, mirror therapy and upper extremity functional exercise.
The program will be implemented for 8 weeks, 3 days a week, under the supervision of a physiotherapist.
Lateralization training will be applied in the first 2 weeks.
Motor imagery training will be implemented in the 3rd and 4th weeks.
For the second stage, the application will be combined with action observation training.
As the 3rd stage, mirror therapy will be performed in the 5th and 6th weeks.
The participant will be asked to perform some exercises while watching the reflection of the intact extremity in the mirror.
In the final stage, they will be asked to physically perform upper extremity functional exercises.
The total treatment time will be 40-50 minutes, with patients receiving 20-30 minutes of modified grade motor imagery and 20 minutes of conventional treatment.
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A modified form of graded motor imagery training and conventional rehabilitation will be applied.
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Experimental: Graded Motor Imagery and Conventional Treatment Group:
The DMI program consists of 3 stages: lateralization, open motor imagery and mirror therapy.
The program will be implemented for 8 weeks, 3 days a week, under the supervision of a physiotherapist.
First, lateralization training will be applied.
In the second stage, motor imagery training will be applied.
This phase will be carried out in a quiet environment by asking the participants to fully focus on the visualization of the movements.
Two methods will be used for the imagined movements.
In particular, visuals of the shoulder and hand used in the lateralization phase will be used to visualize movements related to the normal movement of the upper extremity.
Participants will also be asked to imagine different activities in daily life.
In the final stage, mirror therapy will be applied.
The participant will be asked to perform some exercises while watching the reflection of the intact extremity in the mirror.
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Graded motor imagery training and conventional rehabilitation will be applied.
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Experimental: Conventional Treatment Group:
Within the scope of the conventional treatment Bobath Method, facilitating movement and functional activities in the upper and lower extremities, activating trunk muscles, facilitating basic functional activities such as turning in bed, coming to sit and standing, improving weight bearing while sitting and standing, postural control, balance and walking.
A targeted exercise program will be created.
In line with this goal, upper and lower extremity exercises; don't turn around, don't come to sit, don't stand up; Exercises to activate core muscles; such as bridging, functional reaching; weight bearing and balance training; It is planned to implement walking training.
Treatment time will be 40-50 minutes.
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conventional rehabilitation will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fugl-Meyer Upper Extremity Motor Rating Scale
Time Frame: before treatment, 2 months, 4 months
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The scale is a widely used, reliable and valid test to evaluate paretic upper extremity motor impairment in stroke patients.
From this scale, where each parameter is scored between 0-2 points, a maximum score of 66 can be obtained, and high scores indicate good motor functions.
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before treatment, 2 months, 4 months
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Wolf Motor Function Test (WMFT)
Time Frame: before treatment, 2 months, 4 months
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WMFT is used to evaluate motor skill in patients with upper extremity motor dysfunction.
The 15 functional activities evaluated are scored between 0-5 points and the functional skill score is calculated by taking the average of the total score.
Higher scores indicate better functional ability.
In the performance time section, how long each activity took is recorded.
A maximum of 120 seconds is allowed to complete an activity.
If the activity cannot be completed within this time, the performance time is recorded as 120 seconds.
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before treatment, 2 months, 4 months
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Modified Barthel Index
Time Frame: before treatment, 2 months, 4 months
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MBI, which is used to measure the independence of individuals in daily living activities, emerged by modifying the Barthel Index.
MBI includes 10 items related to activities of daily living.
Total score is between 0-100.
As the score increases, individuals' independence in daily living activities increases.
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before treatment, 2 months, 4 months
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Stroke-Specific Quality of Life Scale
Time Frame: before treatment, 2 months, 4 months
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It consists of a total of 49 items for 12 subcategories (mobility, fitness, upper extremity functionality, work/productivity, mood, self-care, social roles, family roles, language, vision, thinking and personality) that evaluate the quality of life of individuals with stroke.
The higher the total score, the better the stroke individual's quality of life.
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before treatment, 2 months, 4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lateralization Assessment
Time Frame: before treatment, 2 months, 4 months
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Right/left lateralization performance of the upper extremity will be evaluated with the "Recognise™" application developed by the Neuro Orthapedic Institute.
The "Recognise™ Hand" and "Recognise™ Shoulder" sections of this application and the "Vanilla" part of these sections will be used.
Accuracy rates and reaction time in the application will be recorded.
An increase in the accuracy rate indicates that lateralization performance has improved.
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before treatment, 2 months, 4 months
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Mental Chronometry Time
Time Frame: before treatment, 2 months, 4 months
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It will be used to evaluate the chronometric aspect of motor imagery. You will be given the task of wearing and folding a T-shirt for the mental stopwatch period.First, the motor imagery task will be performed. The time written on the screen is recorded by the observer. For the physical phase of the test, the same application is actually carried out and the time is recorded with the help of a stopwatch. Mental stopwatch rate will be calculated. Mental stopwatch ratio = (Time in which the movement is physically performed - Time in which the movement is performed with imagination) / Time in which the movement is physically performed. |
before treatment, 2 months, 4 months
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Kinesthetic and Visual Imagery Questionnaire (KGIA)
Time Frame: before treatment, 2 months, 4 months
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CSIA will be used to evaluate motor imagery skills.
After experiencing the movement in reality, he will be asked to imagine himself watching the same movement as if it were actually performed.
Participants will evaluate the quality of the image in the visualization by giving points between 1 and 5, including "1 (no image)" and "5 (clear as the original)".
An increase in the score indicates improvement.
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before treatment, 2 months, 4 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Yu JA, Park J. The effect of first-person perspective action observation training on upper extremity function and activity of daily living of chronic stroke patients. Brain Behav. 2022 May;12(5):e2565. doi: 10.1002/brb3.2565. Epub 2022 Apr 10.
- Braun N, Kranczioch C, Liepert J, Dettmers C, Zich C, Busching I, Debener S. Motor Imagery Impairment in Postacute Stroke Patients. Neural Plast. 2017;2017:4653256. doi: 10.1155/2017/4653256. Epub 2017 Mar 28.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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