Upper Extremity DysfunctionNCT03196739
Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
A study testing Virtual rehabilitation in people with Upper Extremity Dysfunction and Brain Diseases, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Because virtual reality can provide more enriched environment, repetitive goal-oriented tasks, and increased patients' interest and motivation, it is expected to stimulate neuroplasticity of injured brain and promote recovery in patients with brain disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Dysfunction, Brain Diseases
- What is being tested?
- Virtual rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Jun 2017to 6 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with upper extremity dysfunction due to brain disorders (eg, stroke, traumatic brain injury, brain tumor, etc.)
- Patient who can move the upper limb against the gravity (MRC grade 3 or above in both shoulder and elbow flexion)
- Patient who can maintain stable sitting position
- Adults over 18 years old
- Patients who voluntarily agreed to participate in the study
Who cannot join
- A moderate-to-severe cognitive impairment score of 18 or less in Mini-Mental Status Examination (MMSE)
- Peripheral nerve injury, joint disease, other diseases of the upper extremity dysfunctions other than brain disorders
- Patients with a history of severe dizziness or epilepsy
- Patients with other medical illness that are difficult to participate in the study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Korea Workers' Compensation & Welfare Service Incheon Hospital
Incheon, 21417
Seoul National University Hospital
Seoul, 03080
About this study
Because virtual reality can provide more enriched environment, repetitive goal-oriented tasks, and increased patients' interest and motivation, it is expected to stimulate neuroplasticity of injured brain and promote recovery in patients with brain disorders. On the other hand, immersive virtual reality using a head-mounted display has not yet been attempted in the rehabilitation of patients with brain disorders. In addition to the benefits of existing virtual reality or game rehabilitation, immersive virtual reality can further enhance brain plasticity, such as the effect of mirror therapy or action observation, through self-awareness of the body in the virtual space. The purpose of this study is to investigate the feasibility of applying the immersive virtual reality using a head-mounted display in patients with upper extremity dysfunction due to brain disorders.
- Conditions
- Upper Extremity Dysfunction, Brain Diseases
- Being tested
- Virtual rehabilitation
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual rehabilitationDevice
A total of 10 sessions were held for 30 minutes, 2 to 3 times a week for upper limb rehabilitation using immersive virtual reality under the assistance of an occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| Virtual rehabilitation | Experimental | Upper limb rehabilitation using virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan) Receives: Device: Virtual rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Action Research Arm Test
19 items including grasp, grip, pinch, and gross arm movement
Measured: at study completion, an average of 1 month
Secondary outcomes (5)
Change of Box and Block Test
the number of blocks carried over the partition from one compartment to the other during the one-minute trial period
Measured: at study completion, an average of 1 month
Change of Modified Barthel Index
Evaluation of activities of daily living
Measured: at study completion, an average of 1 month
Time of participation
Total time of patient's participation in the study intervention
Measured: at study completion, an average of 1 month
Patient's satisfaction
Evaluation of patient's satisfaction to the study intervention using a Likert scale
Measured: at study completion, an average of 1 month
Patient's discomfort
Evaluation of patient's discomfort to the study intervention using a Likert
Measured: at study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start20 Jun 2017
- Primary completion30 May 2018
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity DysfunctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Gil Seo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196739
- Sponsor's protocol ID
- VRfeasibility1.2
- Status last verified
- Mar 2018
- First submitted
- 20 Jun 2017
- Last updated
- 8 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders
- ClinicalTrials.gov ID
- NCT03196739
- Acronym / sponsor ID
- VRfeasibility1.2
- Conditions
- Upper Extremity Dysfunction, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 23 Jun 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.
Because virtual reality can provide more enriched environment, repetitive goal-oriented tasks, and increased patients' interest and motivation, it is expected to stimulate neuroplasticity of injured brain and promote recovery in patients with brain disorders. On the other hand, immersive virtual reality using a head-mounted display has not yet been attempted in the rehabilitation of patients with brain disorders. In addition to the benefits of existing virtual reality or game rehabilitation, immersive virtual reality can further enhance brain plasticity, such as the effect of mirror therapy or action observation, through self-awareness of the body in the virtual space. The purpose of this study is to investigate the feasibility of applying the immersive virtual reality using a head-mounted display in patients with upper extremity dysfunction due to brain disorders.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual rehabilitation | Experimental | Device: Virtual rehabilitationUpper limb rehabilitation using virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with upper extremity dysfunction due to brain disorders (eg, stroke, traumatic brain injury, brain tumor, etc.)
- Patient who can move the upper limb against the gravity (MRC grade 3 or above in both shoulder and elbow flexion)
- Patient who can maintain stable sitting position
- Adults over 18 years old
- Patients who voluntarily agreed to participate in the study
Key exclusion criteria (4 listed)
- A moderate-to-severe cognitive impairment score of 18 or less in Mini-Mental Status Examination (MMSE)
- Peripheral nerve injury, joint disease, other diseases of the upper extremity dysfunctions other than brain disorders
- Patients with a history of severe dizziness or epilepsy
- Patients with other medical illness that are difficult to participate in the study
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 rehabilitationA total of 10 sessions were held for 30 minutes, 2 to 3 times a week for upper limb rehabilitation using immersive virtual reality under the assistance of an occupational therapist. | Device | Virtual rehabilitation |
Primary outcome
Change of Action Research Arm Test
Time frame: at study completion, an average of 1 month
19 items including grasp, grip, pinch, and gross arm movement
5 secondary outcomes
Change of Box and Block Test
Time frame: at study completion, an average of 1 month
Change of Modified Barthel Index
Time frame: at study completion, an average of 1 month
Time of participation
Time frame: at study completion, an average of 1 month
Patient's satisfaction
Time frame: at study completion, an average of 1 month
Patient's discomfort
Time frame: at study completion, an average of 1 month
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 8 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual rehabilitation in people with Upper Extremity Dysfunction and Brain Diseases, run by Seoul National University Hospital at 2 sites in South Korea.
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 5 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
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?
Change of Action Research Arm Test (time frame: at study completion, an average of 1 month). 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 8 Jun 2018.