1- Comparison of EEG signal specificity in rehabilitation of stroke patients with two traditional therapies and rehabilitation using virtual reality games
2- Proposing clinical evaluation and rehabilitation methods using patients' brain signal recording
3- Determining the effect of virtual reality on how motor learning in the brain using EEG signal
Design
Clinical trials with control groups, with parallel groups two blind strains are accidental phase 3 on 30 patients. statistical analysis of the study was conducted using spss software and by an uninformed statistical expert on the study.
Settings and conduct
Rehabilitation clinic is performed in Hamadan province. A number of 30 patients with range of motion who are diagnosed with shoulder and elbow mobility problems by a physician are divided into groups A and B after double-blind correction and are rehabilitated by intervention and control. Nine participants are not aware of the expertise of the participants to the study groups.
Participants/Inclusion and exclusion criteria
1 - Lack of cooperation of stroke patients in the study
2- Noise in EEG signal (solution: repeat signal reception) "
Intervention groups
Patients with stroke patients after visiting if they were in the study criteria and tended to participate in the study he said. This sequence is characterized by a non sample individual using از Software Software. A representative of the control group that they receive in traditional rehabilitation. B The intervention group that receive rehabilitation with virtual reality.
Main outcome variables
Clinical parameters of remission
Coping quality parameters related to EEG signal
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051570N1
Registration date:2021-09-25, 1400/07/03
Registration timing:retrospective
Last update:2021-09-25, 1400/07/03
Update count:0
Registration date
2021-09-25, 1400/07/03
Registrant information
Name
Farshid Sheykhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3353 5388
Email address
sheykhi1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality rehabilitation by EEG signal
Public title
Investigating the Effect of rehabilitation along with virtual games on Motor learning functional development to improve motor impairments using EEG
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Rad has limited mobility due to stroke
A maximum of three months have passed since their stroke.
Exclusion criteria:
Abuse of psychotropic drugs - drugs - alcohol and ...
Has limited movement in various parts other than the head and neck.
Be sure not to have birth defects (shoulder and elbow) and be due to stroke.
Have the ability to take an electroencephalogram.
Age
From 2 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Inside the sealed packets was one of the numbers associated with the control group or the intervention group. This number is determined by the person who is not a sampler and is characterized by the use of Random Software Software. The stroke patients randomly selects a number following the visit to the clinic according to the priority of their arrival to the centre, which decides the choice of the code and the patient group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Inside the sealed packets was one of the numbers associated with the control group or the intervention group. This number is determined by the person who is not a sampler and is characterized by the use of Random Software Software. The stroke patients randomly selects a number following the visit to the clinic according to the priority of their arrival to the centre, which decides the choice of the code and the patient group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kermanshah University of Medical Sciences
Street address
Rostay chenar sofla(sheykh)- hajiabad
City
Asadaad
Province
Hamadan
Postal code
65461-43331
Approval date
2021-06-14, 1400/03/24
Ethics committee reference number
IR.KUMS.REC.1400.199
Health conditions studied
1
Description of health condition studied
Patients with limited mobility on the right side of the body due to stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Eeg signal changes due to rehabilitation
Timepoint
45 days
Method of measurement
By recording brain signals
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:this group received conventional upper extremity rehabilitation for stroke patients who need a shoulder and elbow rehabilitation. Conventional rehabilitation means hybrid upper limb functional patterns, scapular, elbow, forearm, wrist, and finger mobility, and slow muscle stretching. The purpose of these exercises is to strengthen weak muscles of the shoulder and elbow in balanced or unbalanced weights to increase joint mobility, relieving muscle power imbalance, gaining control of a transverse limb, reducing muscle stiffness, and gaining a complete range of motion. Shoulder exercises with SWS without VR were performed for maximally 60 minutes by these patients in that way.
Category
Rehabilitation
2
Description
Control group: the stroke patients that receives traditional rehabilitation. this group received conventional upper extremity rehabilitation for stroke patients who need a shoulder and elbow rehabilitation. Conventional rehabilitation means hybrid upper limb functional patterns, scapular, elbow, forearm, wrist, and finger mobility, and slow muscle stretching. The purpose of these exercises is to strengthen weak muscles of the shoulder and elbow in balanced or unbalanced weights to increase joint mobility, relieving muscle power imbalance, gaining control of a transverse limb, reducing muscle stiffness, and gaining a complete range of motion. The patients practiced SWS therapy without using an HMD for maximally 60 minutes, three times a week, and 12 appointments and functional physiotherapy was performed.