StrokeNCT06152328
Virtual Reality Based Mirror Therapy
A study testing Virtual reality applications based on mirror therapy, Conventional treatment and Mirror therapy in people with Stroke and Upper Extremity Paresis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis, Upper Extremity Paralysis
- What is being tested?
- Virtual reality applications based on mirror therapy, Conventional treatment and Mirror therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Intact depth perception in the Titmus Stereopsis assessment
- A score of 24 and above in the Mini-mental test and
- Independent sitting balance
Who cannot join
- Additional neurologic diseases
- Have a head injury
- Have a brain tumor
- Prior cranial surgery
- Psychological disorder or mental problem
- Previous stroke
- Aphasia and apraxia
- Upper extremity amputation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Abant Izzet Baysal University Faculty of Health Science
Bolu, Merkez, 14100
Ramazan Kurul, +90 374 254 10 00 ext. 4135, ramazankurul2@hotmail.com
About this study
Official title: A New Perspective on Mirror Therapy: The Effect of Leap Motion-Based Multi-Axis Immersive Virtual Reality Mirror Therapy (LISA) on Upper Extremity Functions in Individuals With Stroke
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.
Read the detailed description
Stroke is a common neurological condition and one of the significant causes of disability and death. For this reason, stroke is one of the leading causes of disability in adulthood and increases health expenditures in this area. Post-stroke rehabilitation is effective in accelerating recovery and reducing the impact of long-term disabilities, but more studies are needed to understand its specific implications.
Virtual reality applications are a method that has been developing rapidly with the development of technology since the 1980s and is used more widely in simulations and games today. Virtual reality and interactive video games have started to be used as a new treatment method in stroke rehabilitation. The advantage of this method is that it allows the patient to use activity methods that cannot be reached or used in the clinical setting, with plenty of repetitive and visual feedback. Moreover, virtual reality programs are designed to be more entertaining and sustainable for a long time compared to traditional treatment programs. There are no virtual reality devices specially designed for treatment, but the game consoles used in the market are modified for this purpose and used comfortably.
Oculus rift is a console that can create a real virtual reality environment. The individual has a realistic experience by seeing his own avatar and interacting with objects in a world where he will be 360-degree interactive in a designed environment completely isolated from the external environment. It is the most advanced technology of virtual reality applications used today, and it increases the individual's feeling of being in a 3D environment with glasses that use the entire visual field of the person and headphones for the transmission of sounds.
As an alternative treatment approach, mirror therapy has been suggested to be beneficial. Unlike other interventions that use somatosensory input to aid motor recovery, mirror therapy relies on visual stimulation. During mirror therapy, a mirror is placed in the patient's midsagittal plane so that the nonparetic side is mirrored as if it were the affected side. The advantages of mirror therapy are that it is relatively easy to administer and can be self-administered, even for patients with severe motor deficits.
Mirror therapy is claimed to alleviate post-stroke hemiparesis. Studies confirm the positive effects of mirror therapy on patients' mobility in post-stroke upper extremity hemiparesis. The concept of mirror therapy is explained neurophysiologically. Evidence suggests that the same cortical motor areas that are active during the observation of movements are involved in the performance of observed actions.
With the environment to be prepared in virtual reality, the individual will see the exact copy of the movements of the healthy side as the movement of the affected extremity. According to the activity to be selected, the image will be projected as if the affected side is doing the same or the opposite movement. Oculus rift has a structure that covers the entire field of vision with its glasses-shaped apparatus and insulates sounds from outside with its earphones. In this way, it will give the person the feeling of being in the environment much more than the non-immersive virtual reality treatments frequently used in previous studies. The person will see the avatar created in the virtual world in real-time, and the movements will turn into an instant image. The image will cover the person's visual field as in the real world, and the person will see their own body through their own eyes throughout the application.
- Conditions
- Stroke, Upper Extremity Paresis, Upper Extremity Paralysis
- Being tested
- Virtual reality applications based on mirror therapy, Conventional treatment, Mirror therapy, Placebo virtual reality
- Keywords
- Rehabilitation, Virtual Reality Immersion Therapy, Mirror Movement Therapy
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality applications based on mirror therapyOther
Mirror therapy-based games will be played for 30 minutes every day for eight weeks, three days a week, for the VR group.
Conventional treatmentOther
Bobath therapy, walking exercises, upper extremity active exercises, and proprioceptive neuromuscular facilitation techniques will be applied three days a week for eight weeks.
Mirror therapyOther
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 realityOther
For 8 weeks, watching the uninteractive virtual environment
| Study group | Role | What they receive |
|---|---|---|
| VR group | Active comparator | During the exercise, games will be selected from the movements that focus on upper extremity function and require the use of both extremities. These functions will be to grasp the object with both hands, to throw the object, and to provide the object's rotation by revealing the hand's supination-pronation movement. During these movements, the image of the healthy side will be mirrored to the affected side. Before each exercise, what kind of movement requested from the patient will be shown in the VR environment. Receives: Other: Virtual reality applications based on mirror therapy; Other: Conventional treatment |
| Control group | Active comparator | In addition to mirror therapy, Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facilitation techniques, which are traditional physical therapy and rehabilitation methods, will be applied to the control group. In addition, a virtual environment monitoring session will be conducted in non-interactive virtual environments for 10 minutes after their treatment. Receives: Other: Conventional treatment; Other: Mirror therapy; Other: Placebo virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Secondary outcomes (5)
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
Stroke-Specific Quality of Life Scale
It is a stroke-specific, 49-item assessment covering 12 domains to measure quality of life. It measures upper limb function, vision, speech, domestic roles, social roles, mobility, psychological status, work productivity, self-care, perception, memory and personality. Each item is scored by the person himself/herself on a 5-point Likert scale taking into account the last 1 week and high scores indicate good quality of life. The maximum score on the scale is 245.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Apr 2024
- Primary completion2 May 2026
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups parallel design randomized controlled prospective rehabilitation study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Ramazan Kurul, Ph.D, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152328
- Sponsor's protocol ID
- AIBU-FTR-BENLI-004
- Status last verified
- May 2026
- First submitted
- 22 Nov 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Perspective on Mirror Therapy: The Effect of Leap Motion-Based Multi-Axis Immersive Virtual Reality Mirror Therapy (LISA) on Upper Extremity Functions in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT06152328
- Acronym / sponsor ID
- AIBU-FTR-BENLI-004
- Conditions
- Stroke, Upper Extremity Paresis, Upper Extremity Paralysis
- Keywords
- Rehabilitation, Virtual Reality Immersion Therapy, Mirror Movement Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stroke is a common neurological condition and one of the significant causes of disability and death. For this reason, stroke is one of the leading causes of disability in adulthood and increases health expenditures in this area. Post-stroke rehabilitation is effective in accelerating recovery and reducing the impact of long-term disabilities, but more studies are needed to understand its specific implications.
Virtual reality applications are a method that has been developing rapidly with the development of technology since the 1980s and is used more widely in simulations and games today. Virtual reality and interactive video games have started to be used as a new treatment method in stroke rehabilitation. The advantage of this method is that it allows the patient to use activity methods that cannot be reached or used in the clinical setting, with plenty of repetitive and visual feedback. Moreover, virtual reality programs are designed to be more entertaining and sustainable for a long time compared to traditional treatment programs. There are no virtual reality devices specially designed for treatment, but the game consoles used in the market are modified for this purpose and used comfortably.
Oculus rift is a console that can create a real virtual reality environment. The individual has a realistic experience by seeing his own avatar and interacting with objects in a world where he will be 360-degree interactive in a designed environment completely isolated from the external environment. It is the most advanced technology of virtual reality applications used today, and it increases the individual's feeling of being in a 3D environment with glasses that use the entire visual field of the person and headphones for the transmission of sounds.
As an alternative treatment approach, mirror therapy has been suggested to be beneficial. Unlike other interventions that use somatosensory input to aid motor recovery, mirror therapy relies on visual stimulation. During mirror therapy, a mirror is placed in the patient's midsagittal plane so that the nonparetic side is mirrored as if it were the affected side. The advantages of mirror therapy are that it is relatively easy to administer and can be self-administered, even for patients with severe motor deficits.
Mirror therapy is claimed to alleviate post-stroke hemiparesis. Studies confirm the positive effects of mirror therapy on patients' mobility in post-stroke upper extremity hemiparesis. The concept of mirror therapy is explained neurophysiologically. Evidence suggests that the same cortical motor areas that are active during the observation of movements are involved in the performance of observed actions.
With the environment to be prepared in virtual reality, the individual will see the exact copy of the movements of the healthy side as the movement of the affected extremity. According to the activity to be selected, the image will be projected as if the affected side is doing the same or the opposite movement. Oculus rift has a structure that covers the entire field of vision with its glasses-shaped apparatus and insulates sounds from outside with its earphones. In this way, it will give the person the feeling of being in the environment much more than the non-immersive virtual reality treatments frequently used in previous studies. The person will see the avatar created in the virtual world in real-time, and the movements will turn into an instant image. The image will cover the person's visual field as in the real world, and the person will see their own body through their own eyes throughout the application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups parallel design randomized controlled prospective rehabilitation study.
| Arm | Type | Receives |
|---|---|---|
| VR group | Active comparator | Other: Virtual reality applications based on mirror therapy, Other: Conventional treatmentDuring the exercise, games will be selected from the movements that focus on upper extremity function and require the use of both extremities. These functions will be to grasp the object with both hands, to throw the object, and to provide the object's rotation by revealing the hand's supination-pronation movement. During these movements, the image of the healthy side will be mirrored to the affected side. Before each exercise, what kind of movement requested from the patient will be shown in the VR environment. |
| Control group | Active comparator | Other: Conventional treatment, Other: Mirror therapy, Other: Placebo virtual realityIn addition to mirror therapy, Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facilitation techniques, which are traditional physical therapy and rehabilitation methods, will be applied to the control group. In addition, a virtual environment monitoring session will be conducted in non-interactive virtual environments for 10 minutes after their treatment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Intact depth perception in the Titmus Stereopsis assessment
Key exclusion criteria (8 listed)
- Additional neurologic diseases
- Have a head injury
- Have a brain tumor
- Prior cranial surgery
- Psychological disorder or mental problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality applications based on mirror therapyMirror therapy-based games will be played for 30 minutes every day for eight weeks, three days a week, for the VR group. | Other | VR group |
| Conventional treatmentBobath therapy, walking exercises, upper extremity active exercises, and proprioceptive neuromuscular facilitation techniques will be applied three days a week for eight weeks. | Other | Control group, VR group |
| Mirror therapyIn 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. | Other | Control group |
| Placebo virtual realityFor 8 weeks, watching the uninteractive virtual environment | Other | Control group |
Primary outcome
Fugl-Meyer Assessment
Time frame: 8 Weeks
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.
5 secondary outcomes
Evaluation of Cortical Activation with EEG
Time frame: 8 Weeks
Motor Activity Log-28
Time frame: 8 Weeks
Simulator Sickness Questionnaire
Time frame: 8 Weeks
System Usability Scale
Time frame: 8 Weeks
Stroke-Specific Quality of Life Scale
Time frame: 8 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramazan Kurul, Ph.D principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality applications based on mirror therapy, Conventional treatment and Mirror therapy in people with Stroke and Upper Extremity Paresis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramazan Kurul, Ph.D ((0374) 254 10 00 ext. 4135, ramazankurul2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.