The Comparison between Action Observation Therapy and Virtual Reality Training on Upper Extremity Function And Speech Skill In Stroke Patients: Randomized Control Trial
A comparative study of the effect of functional observation therapy and virtual reality therapy based on Kinect along with conventional (traditional) physiotherapy on upper limb function and speech in stroke patients.
Design
Two intervention groups, which will be conducted in parallel and double-blind and randomized in phase 3 on 30 patients. Randomization through the site http://apps.who.int/classifications/icd10/browse /2010/en
Settings and conduct
The research is carried out in the special clinic of Qaim Mashhad Hospital on people with stroke in two randomized double-blind intervention groups (evaluator and allocator).
Participants/Inclusion and exclusion criteria
Inclusion criteria: First stroke, at least three weeks passed, unilateral infarct in the left hemisphere, right hand dominant, mild to moderate aphasia
Exclusion criteria: Severe vision and hearing problems, medical instability, score greater than 2 on the Ashworth scale, complete half-body paralysis.
Intervention groups
Participants will initially receive 20 minutes of the main intervention, in one group of functional observation therapy and in the other group of Kinect-based virtual reality, after they will receive conventional physiotherapy treatment for 45 minutes. took Treatment sessions will be held three times a week for 10 sessions.
1) Functional observation therapy, videos of functional movements of the upper limb will be prepared by a healthy person.After 2 Min, the patients will be given three minutes to perform the corresponding movement.
2) Virtual reality based on Kinect: a virtual environment consisting of 4 games with 5 difficulty levels will be designed. The participant was asked to play the game based on the instructions of the therapist and the instructions and signs of the game.
Main outcome variables
Fugl-Meyer test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221030056342N6
Registration date:2024-11-28, 1403/09/08
Registration timing:prospective
Last update:2024-11-28, 1403/09/08
Update count:0
Registration date
2024-11-28, 1403/09/08
Registrant information
Name
Afsaneh Zeinalzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6710
Email address
zeinalzadehaf@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-08, 1403/09/18
Expected recruitment end date
2026-12-09, 1405/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison between Action Observation Therapy and Virtual Reality Training on Upper Extremity Function And Speech Skill In Stroke Patients: Randomized Control Trial
Public title
Comparison of two therapeutic methods of functional observation and virtual reality in people with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Severe vision and hearing problems
Medical instability
A score of more than 2 on the Ashworth scale
Complete paralysis of half the body
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
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
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2024-09-28, 1403/07/07
Ethics committee reference number
IR.MUMS.FHMPM.REC.1403.143
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
164
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
4
Description
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.
5
Description
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.
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsa Physiotherapy Clinic
Full name of responsible person
Mohammad Parsa
Street address
No. 318, Shahid Kalantari 4, Shahid Kalantari Highway, between Azadi Square and Jamhori-e-Islami Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 903 068 9556
Email
Parsa.m@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
No 163, Deputy of Research and Technology of University, The third floor, University of Medical Sciences, side Hoveize cinema , University Street, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh Zeinalzadeh
Position
Associate Professor, Department of Physiotherapy, Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No 59, Faculty of Paramedical Sciences and Rehabilitation, University Campus, Eastern door of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
sps.Dean@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh Zeinalzadeh
Position
Associate Professor, Department of Physiotherapy, Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No 59, Faculty of Paramedical Sciences and Rehabilitation, University Campus, Eastern door of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
sps.Dean@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh Zeinalzadeh
Position
Associate Professor, Department of Physiotherapy, Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
No 59, Faculty of Paramedical Sciences and Rehabilitation, University Campus, Eastern door of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
sps.Dean@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available