Clinical trial NCT03135418: Effect of Immersive Virtual Reality Usage on Upper Extremity Function in Stroke Patients
Official title: Effect of Immersive Virtual Reality Usage on Upper Extremity Function in Stroke Patients: A Prospective, Double Blinded, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Keywords: Virtual Reality
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Willing to participate
* Mini-Mental State Test score equal or above 25
* Modified Ashworth Scale Score lover then 3

Exclusion Criteria:

* Secondary neurological diseases
* Recurrent strokes
* Reduced or lost visual field on both or single eye(s)
* Full paralysis on affected side

Primary outcomes:
measure: Fugl meyer upper extremity motor evaluations
timeFrame: 6 weeks
Secondary outcomes:
measure: Functional independence scale
timeFrame: 6 weeks
measure: Performance Assessment of Self-Care Skills (PASS)
timeFrame: 6 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
Study officials:
affiliation: Abant Izzet Baysal University
name: Şule Aydın Türkoğlu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Abant Izzet Baysal University
name: Ramazan Kurul, Ms.C
role: PRINCIPAL_INVESTIGATOR
affiliation: Abant Izzet Baysal University
name: Muhammed Nur Öğün, M.D.
role: STUDY_DIRECTOR
affiliation: Abant Izzet Baysal University
name: Şebnem Avcı, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: