Evaluation of the effectiveness of a biofeedback-based rehabilitation model based on muscle synergy model in upper limb mobility in patients with cerebral palsy due to stroke
The purpose of this study was to design and evaluate the effectiveness of a biofeedback-based motor rehabilitation model based on muscle synergy using artificial intelligence tools that can generally improve the quality of life of stroke survivors and be a suitable tool for telemedicine.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 30 patients. Excel software rand function was used for randomization.
Settings and conduct
in order to evaluate and evaluate the motor function of the upper limbs of the subjects, in addition to recording and analyzing the superficial electromyogram signal and analyzing the motion tracking, two Fugel-Meyer and MMSE tests will be used. Specialist in the neurology department of Bu Ali Hospital in Sari will be completed.
Participants/Inclusion and exclusion criteria
entering the study:
No myopathic or anatomical problems/Subjects must be right-handed /24 hours have passed since their stroke and they are in stable condition/Patients should be in the acute phase/The patients must be middle cerebral artery ischemic cerebral palsy/Signing the patient's informed consent form
not entering the study:
Cognitive problem/Unstable clinical condition/Vision problem
hearing problem/They will not be able to record signals and cooperate in research in the day/Previous stroke history/Problem of myopathy before stroke/Hemorrhagic stroke/Chronic phase/Mental retardation
Intervention groups
1: Regular physiotherapy exercises
2: Regular physiotherapy exercises plus biofeedback-based exercises
Duration: 10 sessions for 30 minutes per day in the intervention group on the affected hand(12 people in each group).
Main outcome variables
The characteristics of surface electromyogram signal and motion analysis are in the form of temporal and frequency analysis or Euclidean distance
Fugl Meyer test score (226 points),MMSE (30 points)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200914048720N1
Registration date:2020-10-13, 1399/07/22
Registration timing:registered_while_recruiting
Last update:2020-10-13, 1399/07/22
Update count:0
Registration date
2020-10-13, 1399/07/22
Registrant information
Name
Seyyed Ali Zendehbad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 7289
Email address
ali.zendebad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of a biofeedback-based rehabilitation model based on muscle synergy model in upper limb mobility in patients with cerebral palsy due to stroke
Public title
Design and Effect of Biofeedback Model for Motor Rehabilitation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
These Subjects should be Healthy and have no myopathic or anatomical problems
Subjects must be right-handed
subjects must not athletes
24 hours have passed since their stroke and they are in stable condition
Patients should be in the acute phase
The patients must be middle cerebral artery ischemic cerebral palsy
Signing the patient's informed consent form
Exclusion criteria:
Cognitive problem
Unstable clinical condition
Vision problem
hearing problem
They will not be able to record signals and cooperate in research in the day
Previous stroke history
Problem of myopathy before stroke
Hemorrhagic stroke
Chronic phase
Mental retardation
Age
From 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
10
Non-invasive recording of electromyography (sEMG)and kinematic synergy (4 channels).
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use simple randomization models such as a Heads or Tails, using a random number table or using computer randomization methods and the Python program, and each client, for example, by dropping coins, head and tail in We put the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was divided into control and intervention groups. In this study, patients in both groups were evaluated before the intervention using inclusion criteria and main tests.
Group 1: Regular physiotherapy exercises
Group 2: Regular physiotherapy exercises plus 30 minutes of biofeedback-based training (intervention on the affected hand).
The intervention is also performed as a double-blind randomized clinical trial. Blinding is for 3 groups of subjects, researchers and analysts.
In this study, the evaluators (specialist physician, occupational therapist, and medical engineer) will be completely blind to the type of intervention and the group, because the tests will be evaluated by another team that is familiar with these tools.
Placebo
Not used
Assignment
Parallel
Other design features
For the first time, it covers the challenge between clinical research and the engineering aspects of making biofeedback programs and can lead to the development of an efficient, inexpensive, and telemedicine method of rehabilitation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Bu Ali Hospital (Avicenna Hospital),Pasdaran Boulevard, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2019-09-25, 1398/07/03
Ethics committee reference number
IR.MAZUMS.REC.1398.902
Health conditions studied
1
Description of health condition studied
Hemiplegia due to ischemic stroke in the middle cerebral artery
ICD-10 code
G46.0
ICD-10 code description
Middle cerebral artery syndrome
Primary outcomes
1
Description
Surface electromyogram signal analysis and motion analysis and the score of two Fugl-Meyer and NHISS tests will be used.
Timepoint
1 day after stroke, before intervention, 10 sessions after intervention
Method of measurement
4-channel surface electromyography; Webcam recording; Questionnaires and clinical tests by a neurologist and physiotherapist
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Normal physiotherapy exercises Non-invasive movement exercises for adduction and abduction the arm
Category
Rehabilitation
2
Description
Intervention group: In addition to the usual physiotherapy exercises, movement exercises such as adduction and abduction the arm based on visual feedback and biofeedback-based voice in 10 sessions for 30 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital (Avicenna Hospital)
Full name of responsible person
Athena Sharifi Razavi
Street address
Bu Ali Hospital (Avicenna Hospital),Pasdaran Boulevard, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Fax
+98 11 3334 3010
Email
publicrel@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Reza Kobravi
Street address
Biomedical Engineering Faculty, Ostad Yousefi Boulevard, Kuy-e-Honar, Mashhad,Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3663 0781
Fax
+98 51 3662 1056
Email
HamidRezaKobravi@gmail.com
Web page address
http://mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
N/A
Proportion provided by this source
1
Public or private sector
Private
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
Mazandaran University of Medical Sciences
Full name of responsible person
Athena Sharifi Razavi
Position
Assistant professor of neurology of Mazandaran university of medical science
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Bu Ali Hospital (Avicenna Hospital),Pasdaran Boulevard, Sari, Mazandaran Province