Clinical trial NCT06152328: Virtual Reality Based Mirror Therapy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Upper Extremity Paresis
Upper Extremity Paralysis
Keywords: Rehabilitation
Virtual Reality Immersion Therapy
Mirror Movement Therapy
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-11-30
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups parallel design randomized controlled prospective rehabilitation study.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 8 Weeks
Secondary outcomes:
measure: Evaluation of Cortical Activation with EEG
timeFrame: 8 Weeks
measure: Motor Activity Log-28
timeFrame: 8 Weeks
measure: Simulator Sickness Questionnaire
timeFrame: 8 Weeks
measure: System Usability Scale
timeFrame: 8 Weeks
measure: Stroke-Specific Quality of Life Scale
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University Faculty of Health Science
state: Merkez
Study officials:
affiliation: Abant Izzet Baysal University
name: Ramazan Kurul, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: