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IRCT20200811048372N1 IRCT 2020-10-16 Maryam Soheilifar Comparison of virtual reality plus conventional rehabilitation and conventional rehabilitation alone in patients with stroke Effects of virtual reality plus conventional rehabilitation therapy versus conventional rehabilitation alone on the wrist and elbow spasticity and motor function beside active range of motion in shoulder abduction, wrist extension, and elbow extension in patients with stroke 2020-08-25 anticipated 30 Complete https://irct.ir/trial/50277 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: (number in each block 5 cases with 1:1 ratio for randomization. Patients are numbered according to the time of their registration (the first registered patient: number 1, the second registered patient: number 2, ...). The first five patients will be allocated in one group and the second five patients will be allocated in the other group and this order will be carried out alternatively till the sample size is completed and 15 patients are present each group it is shown in this order; patients 1, 2, 3, 4, 5 in conventional plus VR therapy group, 6, 7, 8, 9, 10 in conventional therapy alone group, 11, 12, 13, 14, 15 in conventional plus VR therapy group, 16, 17, 18, 19, 20 conventional therapy alone group, 21, 22, 23, 24, 25 conventional plus VR therapy group, and 26, 27, 28, 29, 30 in conventional therapy alone group). Overall, there will be six blocks, each with 5 members, with three groups categorized into each method of treatment, Blinding description: In the single blinding, the assessor is not aware of in which group each patient is. N/A stroke. Intervention 1: Interventional group: patients in this group are subjected to a 6 week long period of rehabilitation, three sessions a week, each session consisted of 45 minutes of conventional rehabilitation and 20 minutes of non-immersive Virtual Reality computer gaming. In this VR gaming, patients sit in front of a monitor in order to move their upper extremity according to the instruction of their in-advanced-prepared, specific computer game. In conventional rehabilitation, methods of stretch, positioning, and splint are used in order to improving spasticity; passive movements and assistive movements are used in order to improve range of motion; and targeted movements and active movements are used in order to improve motor function. Intervention 2: Control group: patients in this group are subjected to a 6 week long period of rehabilitation, three sessions a week, each session consisted of 45 minutes of conventional rehabilitation. In conventional rehabilitation, methods of stretch, positioning, and splint are used in order to improving spasticity; passive movements and assistive movements are used in order to improve range of motion; and targeted movements and active movements are used in order to improve motor function. Yes - There is a plan to make this available What will be shared: different physical assessments of patients as; spasticity, motor function, range of motion. demographic data as; age, sex, involved hemisphere, time after stroke. When: the data will be available since December, 2020, and it will be so for 6 months after the publication To whom: people working in academic institutions or physical therapy clinics, neurologists, physicians, and software and IT engineers. Conditions: Any analysis on the date is permitted. Those people who work/study in relevant subjects are eligible for request. Where to obtain: through email, telephone calls, and posting letters. How to obtain: After making a connection through one of the eligible ways, and after providing personal information and the purpose of pursuing this data, after almost 1 week, all answers could be checked and data could be available to the requester. Comments: According to the significant raise in the number of strokes happening across the globe (one stroke per 2-seconds worldwide, and 100 thousand cases of stroke in Iran annually) , and that stroke is the leading cause of disability , this trial could be quite helpful for an unbelievably great number of people across the globe who suffer from disabilities caused by strokes, and it could help them to come back into their normal lives sooner and better than before.
public Maryam Soheilifar
No.1, Behzad alley, Sabari (Ajoudanieh) avenue, Kashanak avenue
Tahran Iran (Islamic Republic of) 1956765163 +98 21 2613 0694 msoheilifar1@yahoo.com Maryam Soheilifar scientific Maryam Soheilifar
No. 1, Behzad alley, Sbari (Ajoudanieh) avenue, Kashanak avenue
Tehran Iran (Islamic Republic of) 1956765163 +98 21 2613 0694 msoheilifar1@yahoo.com Maryam Soheilifar Iran (Islamic Republic of) Patients with age range from 30 to 80 years with ischemic stroke in past three to 12 months Patients admitted in a referral training tertiary healthcare center in 2020 30 years 80 years Both Severe neuro-psychological impairments interfering with recovery Impossibility to follow up the patients I64 Stroke, not specified as haemorrhage or infarction Rehabilitation Rehabilitation Interventional group: patients in this group are subjected to a 6 week long period of rehabilitation, three sessions a week, each session consisted of 45 minutes of conventional rehabilitation and 20 minutes of non-immersive Virtual Reality computer gaming. In this VR gaming, patients sit in front of a monitor in order to move their upper extremity according to the instruction of their in-advanced-prepared, specific computer game. In conventional rehabilitation, methods of stretch, positioning, and splint are used in order to improving spasticity; passive movements and assistive movements are used in order to improve range of motion; and targeted movements and active movements are used in order to improve motor function. Control group: patients in this group are subjected to a 6 week long period of rehabilitation, three sessions a week, each session consisted of 45 minutes of conventional rehabilitation. In conventional rehabilitation, methods of stretch, positioning, and splint are used in order to improving spasticity; passive movements and assistive movements are used in order to improve range of motion; and targeted movements and active movements are used in order to improve motor function. 1) The wrist spasticity at baseline and after six weeks by Modified Ashworth upper extremity score. Timepoint: one turn before intervention, and another 6 weeks after intervention. Method of measurement: Modified Ashworth upper extremity score. 2) The elbow spasticity at baseline and after six weeks by Modified Ashworth upper extremity score. Timepoint: one turn before intervention, and another 6 weeks after intervention. Method of measurement: Modified Ashworth upper extremity score. 3) Motor function at baseline and after six weeks by Fugle-Meyer upper extremity score. Timepoint: one turn before intervention, and another 6 weeks after intervention. Method of measurement: Fugle-Meyer upper extremity score. 4) Active range of motion in shoulder abduction calculated by single blinded assessor with goniometry at baseline and after six weeks. Timepoint: one turn before intervention, and another 6 weeks after intervention. Method of measurement: calculated by single blinded assessor with goniometry. 5) Active range of motion in wrist extension calculated by single blinded assessor with goniometry at baseline and after six weeks. Timepoint: one turn before intervention, and another 6 weeks after intervention. Method of measurement: calculated by single blinded assessor with goniometry. 6) Active range of motion in elbow extension calculated by single blinded assessor with goniometry at baseline and after six weeks. Timepoint: one turn before intervention, and another 6 weeks after intervention. Method of measurement: calculated by single blinded assessor with goniometry. Maryam Soheilifar Approved 2020-08-21 Ethic Committee of Tehran University of Medical Sciences No. 1, northern door, Poursina St., Quodds St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)