StrokeNCT03135418
Effect of Immersive Virtual Reality Usage on Upper Extremity Function in Stroke Patients
A study testing Intervention in people with Stroke and Rehabilitation, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 6 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate
- Mini-Mental State Test score equal or above 25
- Modified Ashworth Scale Score lover then 3
Who cannot join
- Secondary neurological diseases
- Recurrent strokes
- Reduced or lost visual field on both or single eye(s)
- Full paralysis on affected side
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Immersive Virtual Reality Usage on Upper Extremity Function in Stroke Patients: A Prospective, Double Blinded, Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Stroke, Rehabilitation
- Being tested
- Intervention, Control
- Keywords
- Virtual Reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
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.
ControlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks. Receives: Device: Intervention |
| Control | Sham comparator | 25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift a will be used to create an immersive visual environment.Patient will be watching the premade scenarios without interaction. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire, Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl meyer upper extremity motor evaluations
Evaluates and measures recovery in post-stroke hemiplegic patients. Motor Test requires Tennis ball, A small spherical shaped container, A tool to administer reflex tests, Enough space is needed for a patient to move around freely, if possible space should be a quiet
Measured: 6 weeks
Secondary outcomes (3)
Functional independence scale
Measures the level of a patient's disability and indicates how much assistance is needed for the individual to carry out activities of daily living
Measured: 6 weeks
Performance Assessment of Self-Care Skills (PASS)
Purpose of PASS is to demonstrate independence, adequacy, and safety are rated on four-point scales.
Measured: 6 weeks
Action Research Arm Test (ARAT)
Assesses upper limb functioning using observational methods. Focuses on grip, grasp and pinch motions of hand
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 May 2017
- Primary completion1 Oct 2017
- Study completion6 Oct 2017
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
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Şule Aydın Türkoğlu, M.D., Principal investigator, Abant Izzet Baysal UniversityRamazan Kurul, Ms.C, Principal investigator, Abant Izzet Baysal UniversityMuhammed Nur Öğün, M.D., Study director, Abant Izzet Baysal UniversityŞebnem Avcı, Ph.D., Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135418
- Sponsor's protocol ID
- AbantIBU-Neu1
- Status last verified
- Apr 2018
- First submitted
- 26 Apr 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After publication of article all outcomes will be open to others researches with an excel data sheet. Researchers can contact corresponding researcher with his contact mail and request data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersive Virtual Reality Usage on Upper Extremity Function in Stroke Patients: A Prospective, Double Blinded, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03135418
- Acronym / sponsor ID
- AbantIBU-Neu1
- Conditions
- Stroke, Rehabilitation
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 6 Oct 2017 (actual)
- First posted
- 1 May 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Intervention25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks. |
| Control | Sham comparator | Device: Control25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift a will be used to create an immersive visual environment.Patient will be watching the premade scenarios without interaction. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire, Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to participate
- Mini-Mental State Test score equal or above 25
- Modified Ashworth Scale Score lover then 3
Key exclusion criteria (4 listed)
- Secondary neurological diseases
- Recurrent strokes
- Reduced or lost visual field on both or single eye(s)
- Full paralysis on affected side
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 |
|---|---|---|
| InterventionPatients 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. | Device | Intervention |
| ControlThe 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. | Device | Control |
Primary outcome
Fugl meyer upper extremity motor evaluations
Time frame: 6 weeks
Evaluates and measures recovery in post-stroke hemiplegic patients. Motor Test requires Tennis ball, A small spherical shaped container, A tool to administer reflex tests, Enough space is needed for a patient to move around freely, if possible space should be a quiet
3 secondary outcomes
Functional independence scale
Time frame: 6 weeks
Performance Assessment of Self-Care Skills (PASS)
Time frame: 6 weeks
Action Research Arm Test (ARAT)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: Undecided. After publication of article all outcomes will be open to others researches with an excel data sheet. Researchers can contact corresponding researcher with his contact mail and request data.
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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. This study is not recruiting at the moment.
Şule Aydın Türkoğlu, M.D. principal investigator
Abant Izzet Baysal University
Ramazan Kurul, Ms.C principal investigator
Abant Izzet Baysal University
Muhammed Nur Öğün, M.D. study director
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 Intervention in people with Stroke and Rehabilitation, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Apr 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl meyer upper extremity motor evaluations (time frame: 6 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 19 Apr 2018.