Virtual Reality Based Mirror Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorAbant Izzet Baysal University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Virtual reality applications based on mirror therapy

    Other intervention

    Mirror 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 intervention

    Bobath 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 intervention

    In 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 intervention

    For 8 weeks, watching the uninteractive virtual environment

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: VR groupActive comparator 2 interventions
Group B: Control groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
8 Weeks

Secondary outcomes

1

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.

Time frame
8 Weeks
2

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.

Time frame
8 Weeks
3

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.

Time frame
8 Weeks
4

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.

Time frame
8 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abant Izzet Baysal University

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator