About this trial
The aim of this study is to examine the effectiveness of 3D virtual reality assisted mirror therapy based rehabilitation applications compared to classical methods used in stroke rehabilitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a ischemic stroke
Stroke duration not less than 2 months and not more than 6 months
Individuals with a score of 2b and 3 according to the Thrombolysis in cerebral infarction (TICI) scale
A score of 2 and above according to the upper extremity motor assessment of the NIH stroke scale
Disqualifiers
Additional neurologic diseases
Have a head injury
Have a brain tumor
Prior cranial surgery
Trial design
Parallel
Treatments tested in this trial
Virtual reality applications based on mirror therapy
Other interventionMirror therapy-based games will be played for 30 minutes every day for eight weeks, three days a week, for the VR group.
Conventional treatment
Other interventionBobath therapy, walking exercises, upper extremity active exercises, and proprioceptive neuromuscular facilitation techniques will be applied three days a week for eight weeks.
Mirror therapy
Other interventionIn conventional mirror therapy, the unaffected extremities of the individuals will be positioned outside the mirror, while the affected extremities will be placed inside the mirror so that the patient cannot see them. In this way, the image of the intact hand will be transferred to the affected side and activities will be performed three days a week for eight weeks.
Placebo virtual reality
Other interventionFor 8 weeks, watching the uninteractive virtual environment
Treatment groups
Trial outcomes
Primary outcomes
Fugl-Meyer Assessment
It is a scale based on measuring upper extremity performance in stroke patients. Test; reflex activity, flexor and extensor synergy, combined synergistic movements, non-synergy movements, normal reflex activity, wrist and hand evaluation, coordination and speed evaluation subsections. It consists of 33 items in total, and each item is scored between 0 and 2 points (0: unable, 1: partially able, 2: fully able). The total score is 66.
Secondary outcomes
Evaluation of Cortical Activation with EEG
EEG signals will be recorded over the mu rhythm during rest and imagery tasks. Mu rhythm activity increases during rest and is suppressed during purposeful exercise or activity observation. This mu rhythm suppression is expressed as activation of relevant brain areas.
Motor Activity Log-28
It will be used to assess the spontaneous use of the hemiparetic limb in daily life. The MAG-28 is one of the commonly used assessment tools to assess activity according to the ICF. The MAG-28 consists of two scales and assesses the frequency of use and quality of movement of the affected upper extremity during 28 activities of daily living such as buttoning a shirt, opening a drawer, brushing teeth.In the scale, activity is scored between 0-5. A high score on the scale indicates that the frequency of upper limb use and quality of movement during activity is better.
Simulator Sickness Questionnaire
It has been widely used to assess various forms of illness triggered by virtual environments. It is constructed by transforming symptoms that participants subjectively report the presence and severity of on a scale. The Simulator Sickness Questionnaire assesses 16 symptoms such as eyestrain, nausea, sweating and headache on 4 different severity ratings (none, mild, moderate and severe). Higher scores indicate stronger beliefs about the underlying symptoms of illness. Military pilots with a total score above 20 are considered " poor-failure". The Virtual Reality Sickness Questionnaire, specifically developed to evaluate symptoms triggered by virtual environments. The questionnaire categorizes symptoms into two non-exclusive categories: general symptoms and ocular symptoms. Symptoms are rated on a scale of four severity levels (none, mild, moderate, and severe). A higher number of symptoms and total scores indicate lower tolerance to the virtual environment.
System Usability Scale
It consists of 10 statements that allow evaluating the ease of use (or lack thereof) of websites, software, hardware, mobile devices and other technological applications at a glance. Using a 5-point Likert scale, the SUS is basically a questionnaire for assessing usability and has Turkish validity. The average value of the SUS score is taken as 68, and an SUS score greater than 68 indicates that the system is above average, while a score below 68 indicates that the system is below average. The products with the highest usability ratings are classified as A+ and the percentage range is between 96-100.
Sponsors and contacts
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Abant Izzet Baysal University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator