Effect of Immersive Virtual Reality Usage on Upper Extremity Function in Stroke Patients
Condition: Stroke; Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In this study we aimed to determine whether the additional rehabilitation with 3D virtual
      reality headsets provide any functional contribution to conventional rehabilitation
      techniques of upper extremity in patient with stroke.

      Forty patients with stroke history no more than 2 years will be included in this study.
      Patients will randomly be divided into 2 groups as control and intervention. Conventional
      rehabilitation techniques will be applied for 4 weeks in both groups. Intervention group will
      receive a 3D virtual reality rehabilitation training, each lasts 45 minutes, with a special
      headset 3 times a week for 4 weeks in addition to conventional rehabilitation. Patients will
      be assessed with Fugl-Meyer, Action Research Arm Test and Functional Independence Measurement
      at baseline and 4 weeks after first assessment. It will be evaluated that whether 3d virtual
      reality rehabilitation training provides any benefit to stroke rehabilitation.
    

Detailed description: 
      According to the World Health Organization, cerebrovascular accident (CVA) or stroke is a
      rapidly evolving clinical manifestation, resulting death or lasting longer than 24 hours, due
      to local or general impairment of cerebral function without any cause other than vascular
      causes. These findings are due to the rapid loss of brain functions and impaired blood flow
      of the brain. Stroke is a cause of death and permanent neurological damage. After the
      disruption of the blood flow, the affected area of the brain loses its function. Hemiparesis
      and hemiplegia, aphasia, apraxia, dysarthria, loss of a visual field, and personality changes
      can occur. Stroke is a common neurological problem and one of the major causes of disability
      and death. In patients with stroke, the mortality rate is at the 30% level and there is an
      increasing the rate of morbidity. Therefore, stroke is one of the main causes of increasing
      health care costs in the adulthood. It has been shown that post-stroke rehabilitation might
      be effective in improving stroke symptoms and increasing independency however more study is
      needed to understand its specific effects.

      Virtual reality applications are used predominantly in simulations and games, which has been
      developing rapidly with the development of day to day technology from 1980's. In medical
      field, it used for training of many diagnostic and therapeutic interventions such as
      laparoscopy and bronchoscopy in addition to rehabilitation. Reality and interactive video
      games have started to be used as a new treatment method in stroke rehabilitation. The
      advantage of this technology is that the types of activity which cannot be achieved or cannot
      be used in the clinical setting allow the patient to use it with abundant repetitive and
      visual feedback. Moreover, virtual reality programs are designed to be more fun and
      sustainable than traditional treatment programs. There is not any virtual reality device
      specially designed for use in therapy, but the game consoles used in the market can be
      modified and used for this purpose.

      Oculus rift is an immersive console with the ability to create a real virtual environment. In
      a world where the individual is completely isolated from the outside and will be 360 degrees
      interactive in the designed environment, person has a near-real experience by seeing its own
      avatar and interacting with objects. There are two screens that are placed separately for
      each eye. These screens create stereoscopic 3D images by creating two separate images for the
      right and left eye. The accelerometer, gyroscope and magnetometer on the device are able to
      detect the direction and speed of movement. The greatest advantage of the oculus rift
      compared to other devices is that it prevents motion sickness such as nausea, dizziness and
      headache. Compared to older models, the new technology allows for a near-realistic
      environment design and object tracking, allowing the individual to use the device for
      extended periods of time without exposure to nausea and headaches.

      Leap motion tracking system can mounted to oculus headset and it tracks the hands motion
      without requiring any other sensory device on the hand. Real time motion tracking provides a
      reliable visual output. Patients can interact virtual environment get feedbacks from program
      and see the result of their actions which is most needed to facilitate the plasticity. In
      order to get a good plasticity response 3 stimulation methods needed which is action from
      effected side, motor imagery and action observation. All 3 components can be achieved with
      usage of immersive virtual reality combined with a motion tracking.

      Considering an 80% test power and an α > of 0.05, a minimum of 21 patients were needed for
      each group. Patients met the inclusion criteria will divide into two groups with a random
      number generator (considering gender, age and affected side) software as intervention and
      control groups.

      At the first evaluation session, information of the cases that are considered appropriate to
      participate to the study will be recorded on the patient evaluation form. The assessments
      will be repeated at the beginning of the treatment schedule and at the end of the 4th week.
      Medical records like stroke onset, effected brain region, medications and detailed history
      will be provided by a neurologist.

      The initial assessment will be done in the first day of the application before beginning the
      therapy and the last assessment will be done at the end of the 4th week. Mini Mental State
      Examination (MMSE) will be done to evaluate the cognitive status and cooperative skills.
      Patients scored 25 or more MMSE will be included to sudy.Modified Ashworth Scale (MAS),
      Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer
      upper extremity motor evaluations will be applied before the rehabilitation program, after
      the intervention and at the end of 4 weeks.

      It is considered that the use of oculus rift device in rehabilitation; i) may increase the
      efficiency of stroke rehabilitation and functional independence by increasing the
      participation of individuals ii) may increase the perception of the correct movement of the
      individuals iii) may allow measuring the effectiveness of rehabilitation numerically,
      different from other subjective methods.
    

Intervention name(s): Intervention; Control
Intervention type(s): Device; Device
Intervention description(s): Patients will use virtual reality d4evice to play task oriented games like bowling, arrow shooting and home activity simulations which focuses upper extremity abduction, flexion and rotation movements. Each session will be a total of 45 minutes divided to 3 15 minute games. Sessions will held for 6 weeks each monday, wednesday and friday at same time for each patient.
In addition to the virtual reality treatment program conventional rehabilitation therapies including neurodevelopmental facilitation techniques, physiotherapy, and occupational therapy and, where necessary, speech therapy will be applied according to the needs of the patient.; The control group will be included in the virtual reality program only focusing on visual scenes without upper extremity interaction. Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facial techniques will be applied to the control group for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients' information and contact will be obtaioned from neurologist and willing participant's gender, age and stroke onset data will be processed with a random number generator. Patients will divide into two groups as intervention and control with a normal distrubution of gender, age and stroke onset.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Virtual Reality