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IRCT20221030056342N6 IRCT 2024-11-28 Mashhad University of Medical Sciences Comparison of two therapeutic methods of functional observation and virtual reality in people with stroke The Comparison between Action Observation Therapy and Virtual Reality Training on Upper Extremity Function And Speech Skill In Stroke Patients: Randomized Control Trial 2024-12-08 anticipated 30 Recruiting https://irct.ir/trial/79450 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the quadruple random block method will be used. In this method, the volume of each block must be determined first (for example, a quadruple block). Then write the list of blocks and assign numbers to them (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) then choose random numbers between 1 and 6 (for example, 1, 4, 5, etc.) and finally specifying the treatment allocation list based on the previous random numbers (AABB-BBAA-BABA-).}, Blinding description: The patients were randomly assigned to two groups of conventional (traditional) physiotherapy along with functional observation treatment (group A) and conventional (traditional) physiotherapy along with four groups by a person who is not involved in any of the intervention and evaluation stages. Virtual reality treatment based on Kinect (group B) will be assigned. At the same time, the person who measures the results before and after the treatment will also be blind. 3 stroke. Intervention 1: Intervention group: Videos of the functional movements of the upper limbs in different directions and angles will be prepared by a healthy person under the supervision of the research team at the virtual training center of Mashhad University of Medical Sciences. In the therapy session, each training movement will be shown to the participants for two minutes and for better understanding, first at half speed and then at normal speed. After observing the desired therapeutic movement, patients will be given three minutes to perform targeted functional exercise to perform the corresponding movement. After a minute of rest, the next video will be shown, and in the same way, people with stroke will watch and practice the next movement therapy video. In each session, 4 movements will be given for therapeutic exercise and the range of movement will gradually increase in the next sessions according to the conditions of each patient. On the other hand, the degree of difficulty and complexity of the movements will also increase. For example, in the first week, the movement in question will include only one joint, and in the last week, the movement will take place in several joints at the same time. After that, the people participating in the research will be treated with conventional (traditional) physiotherapy for 45 minutes. Treatment sessions will be held three times a week for 10 sessions. which includes 17 minutes of electrotherapy in the form of placing FES current on the extensor muscles of the elbow, wrist and fingers in the upper limb and dorsiflexor in the lower limb. After that, there will be a therapeutic exercise for 20 minutes. Intervention 2: Intervention group: In this study, Kinect xbox 360 imaging system and Kinect for windows SDK 1.8 will be used to track and record and receive upper limb movement information of stroke patients, a 52-inch monitor and a laptop system with Windows 10.Also, a virtual environment consisting of 4 games with 5 levels of difficulty will be designed by engineers using Unity 2020 game software. Python 3 programming language and opencv library were also used to process images. sqlserver database will also be used to store information. Participants will be familiar with the process of playing practice games. The choice of sports game will be made by the therapist based on the abilities, interests and motivation of the patient. The participant was asked to stand or sit and be at a distance of 4 meters from the Kinect device and play the game based on the instructions of the therapist and the instructions and signs of the game. If necessary, patients could use a chair without a handle and back to prevent falling. The patient will be placed in front of the monitor and the camera will receive the person's movements and enter the virtual reality environment. The treatment consists of several games that involve upper limb movements in different directions and joints. By doing the movements correctly, for example, passing the obstacles, the participant earns points. For every 5 minutes of the game, one minute rest is given to the person to avoid fatigue. In order to improve the practice in the coming weeks, the degree of difficulty of the games will increase according to the conditions of each person. After that, the people participating in the research will be treated with conventional (traditional) physiotherapy for 45 minutes. Treatment sessions will be held three times a week for 10 sessions,which includes 17 minutes of electrotherapy in the form of placing FES current on the extensor muscles of the elbow, wrist and fingers in the upper limb and dorsiflexor in the lower limb. After that, there will be a therapeutic exercise for 20 minutes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The results of the current research will be available to researchers in the form of an article.
public Afsaneh Zeinalzadeh
No 59, Faculty of Paramedical Sciences and Rehabilitation, University Campus, Eastern door of Ferdowsi University of Mashhad, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 sps.Dean@mums.ac.ir Mashhad University of Medical Sciences scientific Afsaneh Zeinalzadeh
No 59, Faculty of Paramedical Sciences and Rehabilitation, University Campus, Eastern door of Ferdowsi University of Mashhad, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 sps.Dean@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) First stroke At least three weeks have passed since the stroke Unilateral infarct in the left hemisphere The right hand should be the dominant hand based on the Edinburgh test Mild to moderate severity of aphasia 18 years 65 years Both Severe vision and hearing problems Medical instability A score of more than 2 on the Ashworth scale Complete paralysis of half the body 164 Stroke, not specified as haemorrhage or infarction Rehabilitation Rehabilitation Intervention group: Videos of the functional movements of the upper limbs in different directions and angles will be prepared by a healthy person under the supervision of the research team at the virtual training center of Mashhad University of Medical Sciences. In the therapy session, each training movement will be shown to the participants for two minutes and for better understanding, first at half speed and then at normal speed. After observing the desired therapeutic movement, patients will be given three minutes to perform targeted functional exercise to perform the corresponding movement. After a minute of rest, the next video will be shown, and in the same way, people with stroke will watch and practice the next movement therapy video. In each session, 4 movements will be given for therapeutic exercise and the range of movement will gradually increase in the next sessions according to the conditions of each patient. On the other hand, the degree of difficulty and complexity of the movements will also increase. For example, in the first week, the movement in question will include only one joint, and in the last week, the movement will take place in several joints at the same time. After that, the people participating in the research will be treated with conventional (traditional) physiotherapy for 45 minutes. Treatment sessions will be held three times a week for 10 sessions. which includes 17 minutes of electrotherapy in the form of placing FES current on the extensor muscles of the elbow, wrist and fingers in the upper limb and dorsiflexor in the lower limb. After that, there will be a therapeutic exercise for 20 minutes. Intervention group: In this study, Kinect xbox 360 imaging system and Kinect for windows SDK 1.8 will be used to track and record and receive upper limb movement information of stroke patients, a 52-inch monitor and a laptop system with Windows 10.Also, a virtual environment consisting of 4 games with 5 levels of difficulty will be designed by engineers using Unity 2020 game software. Python 3 programming language and opencv library were also used to process images. sqlserver database will also be used to store information. Participants will be familiar with the process of playing practice games. The choice of sports game will be made by the therapist based on the abilities, interests and motivation of the patient. The participant was asked to stand or sit and be at a distance of 4 meters from the Kinect device and play the game based on the instructions of the therapist and the instructions and signs of the game. If necessary, patients could use a chair without a handle and back to prevent falling. The patient will be placed in front of the monitor and the camera will receive the person's movements and enter the virtual reality environment. The treatment consists of several games that involve upper limb movements in different directions and joints. By doing the movements correctly, for example, passing the obstacles, the participant earns points. For every 5 minutes of the game, one minute rest is given to the person to avoid fatigue. In order to improve the practice in the coming weeks, the degree of difficulty of the games will increase according to the conditions of each person. After that, the people participating in the research will be treated with conventional (traditional) physiotherapy for 45 minutes. Treatment sessions will be held three times a week for 10 sessions,which includes 17 minutes of electrotherapy in the form of placing FES current on the extensor muscles of the elbow, wrist and fingers in the upper limb and dorsiflexor in the lower limb. After that, there will be a therapeutic exercise for 20 minutes. Fugl-Meyer assessment scale for the upper limb. Timepoint: Before and immediately after treatment. Method of measurement: This scale has been validated in terms of psychometric properties and is a quantitative measure of motor disability in hemiplegia patients after stroke. It includes 6 areas of reflexes, voluntary movements, coordination, speed, sense and passive movements. In the movement part, the upper limbs, wrists and fingers and the speed and coordination of movements are evaluated. Items are scored using a three-point scale (0 = cannot do; 1 = partially does; 2 = completely does) and a total score of 66 is calculated. Functional reach test. Timepoint: Before and immediately after treatment. Method of measurement: In this test, the participant stands next to the wall and raises the upper body up to the shoulder with a straight elbow. This point is considered as zero, then the person bends forward or sideways by keeping the support level fixed. This distance is measured to the zero point. The score of the Persian version of the naming skill questionnaire. Timepoint: Before and immediately after treatment. Method of measurement: This test is performed in order to assess the vulnerability of verbal naming memory using semantic guidance and phonetic guidance of dyslexic patients. This test has 50 images in different categories, which are selected according to the type and diversity of the category in three groups of animals (12 items), natural categories (11 items) and man-made categories (27 items). To perform the test, each picture is shown to the patient one by one and in order, and he is asked to name them. The type of patient's answer is also noted in the answer letter. If the participant cannot answer after ten seconds, he will first receive semantic guidance, and if he is still unable to answer, phonetic guidance will be provided to the patient by repeating the beginning consonants of the target word. The participant's answers will also be recorded against the target word. In examining the validity of the test on 32 dyslexic patients aged 40 to 68, the internal consistency coefficient was 0.96 and the test-retest coefficient was 0.87. Severity of aphasia. Timepoint: Before and immediately after treatment. Method of measurement: To check the severity of aphasia, the speech and language pathologist will use Dr. Nilipour's aphasia test, the validity and reliability of which has been obtained in Farsi. In this test to check the severity of aphasia, the version of the aphasia questionnaire includes five items that include conversation and impromptu speech (answering targeted questions, free speech and describing illustrated stories), listening comprehension (yes and no questions, listening comprehension of words, commands continuous and short story comprehension), oral expression (psychomotor speech, automatic speech, memorizing song fragments, single word answers, repeating words and phrases, reading words and sentences and naming), Reading (reading and questioning texts) and understanding written language (recognition of letters and words, phonetic association, word-to-picture matching, transcription, dictation and free writing) will be used. In this questionnaire, the cutoff score is 93.8. Scores lower than this amount will be classified in four categories. Mild severity (AQ = 76-93), moderate severity (AQ = 51-75), severe (AQ = 25-50) and very severe (less than 25) (AQ). In this study, patients were divided into two groups. severe (AQ = less than 50) and non-severe (above AQ = 50) will be classified. Persian version of the Stroke and Aphasia Quality of Life Scale. Timepoint: Before and immediately after treatment. Method of measurement: This questionnaire, which is completed by the patient, has 39 items that include 12 areas: movement, self-care, upper limb function, occupational activities, language, thinking, personality, mood, energy level, role in society. and family This questionnaire was translated and localized in Farsi by Khatunabadi et al. Montreal Cognitive Assessment Test score. Timepoint: Before and immediately after treatment. Method of measurement: The Montreal Cognitive Assessment Test is a valid and repeatable test and is used to evaluate the cognitive performance of neurological patients. The test items include 8 cognitive domains, which are visual-spatial and executive, naming, memory, attention, language, abstract concepts, delayed recall, and awareness. Each domain contains several questions and is scored out of 30. Mashhad University of Medical Sciences Approved 2024-09-28 Mashhad University of Medical Sciences No 311,Central Organization of Mashhad University of Medical Sciences, Danesh and Salamat Township, between Shahid Al Shahidi Square and Shahid Javan Square, At the end of Shahid Fakuri Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)