Effectiveness of Modified Graded Motor Imagery Training in Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326749
• Other study ID #: 2024/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: June 2024
• Source: Inonu University
• Contact: Havva ADLI, pHD(c)
• Phone: 05369831133
• Email: h.adli[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the study, movement observation training, Modified Graded Motor Imaging Training, which includes upper extremity functional exercises, and Graded Motor Imaging Training, where the standard protocol is applied, will be used in stroke patients to improve their upper extremity motor functions and daily lives. It is aimed to present it on an evidence-based basis by investigating its effects on Daily Living Activity, quality of life, upper extremity-specific right/left lateralization performance, mental stopwatch performance and motor imagery skills.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: March 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Motor Imagery
• Stroke

Intervention

Other:
• Modified Graded Motor Imagery and Conventional Treatment Group
A modified form of graded motor imagery training and conventional rehabilitation will be applied.
• Graded Motor Imagery and Conventional Treatment Group
Graded motor imagery training and conventional rehabilitation will be applied.
• Conventional Treatment Group
conventional rehabilitation will be applied.

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Upper Extremity Motor Rating Scale	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.	before treatment, 2 months, 4 months
Primary	Wolf Motor Function Test (WMFT)	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.	before treatment, 2 months, 4 months
Primary	Modified Barthel Index	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.	before treatment, 2 months, 4 months
Primary	Stroke-Specific Quality of Life Scale	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.	before treatment, 2 months, 4 months
Secondary	Lateralization Assessment	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.	before treatment, 2 months, 4 months
Secondary	Mental Chronometry Time	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
Secondary	Kinesthetic and Visual Imagery Questionnaire (KGIA)	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.	before treatment, 2 months, 4 months