Physical DisabilityNCT04562662
Evaluation of mediVR-KAGURA Guided Therapy
A study testing mediVR KAGURA in people with Physical Disability and Cognitive Dysfunction, run by Japan Society of Clinical Research at 1 site in Japan.
Trial summary
The objective is to evaluate mediVR-KAGURA guided therapy for the treatments of physical and cognitive dysfunctions regardless of baseline disease in a prospective interventional design. Read more about this study
- Who is it for?
- Ages 6 to 110 years
- Conditions the study is for
- Physical Disability, Cognitive Dysfunction
- What is being tested?
- mediVR KAGURA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 1 Sep 2020to 31 Mar 2022
- 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 6 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with physical and/or cognitive dysfunctions
- Agreed to the participation of this study with written informed consent by themselves or guardians
Who cannot join
- 1. Inappropriate candidates at attending physician's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of mediVR-KAGURA Guided Therapy: A Prospective Interventional Study
The objective is to evaluate mediVR-KAGURA guided therapy for the treatments of physical and cognitive dysfunctions regardless of baseline disease in a prospective interventional design.
Read the detailed description
The patients sit on an upright chair, wear a head-mounted display (HMD) and grab two handheld controllers in a motion-tracked three-dimensional space called "room scale" of the mediVR-KAGURA (mediVR, Inc. Toyonaka City, Osaka, Japan). mediVR-KAGURA can provide users with >90 frames per second (fps) graphic operation with an approximately 110° viewing angle and accurate three-dimensional tracking technology.
First, we evaluate conventional and maximum reaching distances at 0°, 45°, and 90° level surface for the left hand (0L, 45L, 90L) and at 90°, 135°, and 180° level surface for the right hand (90R, 135R, or 180R) for calibration in a sitting position. During rehabilitation, patients are instructed to touch a fixed objects or catch a falling objects at the pre-specified height and distance levels in each degree. Horizontal distances were classified into three categories, namely long, middle, and short which were calculated using the following formulas: 0.9 * maximum reaching distance, 0.9 * (conventional + maximum reaching distances)/2, and conventional reaching distance respectively. A falling object disappeared at a 20 cm height for safety if the patients missed to catch it. The purpose of reaching hands was to stimulate and break down body trunk balance, and to train participants to balance for stable walking. By thinking about the timing and distance and recognizing the next targets repeatedly, cognitive function was simultaneously stimulated for dual-task training.
The 7 parameters of the rehabilitation programs can be set like as follows: (1) distance (short, middle or long), (2) direction (0L, 45L, 90L, 90R, 135R, or 180R), (3) height of object, (4) size of object (center or outline), (5) size of sensing sphere of the controller, (6) falling speed of the square box (from 0 to 300 cm/s), and (7) intervals for each task. Participants first underwent practical programs to familiarize themselves with mediVR-KAGURA guided rehabilitation, followed by rehabilitation programs. Provision of the rehabilitation programs will be personalized.
- Conditions
- Physical Disability, Cognitive Dysfunction
- Being tested
- mediVR KAGURA
- Keywords
- Virtual Reality, Physical, Cognitive
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediVR KAGURADevice
Approximately 20 min mediVR KAGURA-guided rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Single arm (all participants receive interventions) Receives: Device: mediVR KAGURA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Timed up and go test
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. Shorter score means a better outcome. The minimum value could be 5 seconds or less, and the maximum value could be infinity (cannot complete the test).
Measured: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Change in Trail Making Test
The Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. Shorter score means a better outcome. The minimum value could be 15 seconds or less, and the maximum value could be infinity or be defined as 300 seconds when patients cannot complete the test.
Measured: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Secondary outcomes (4)
Changes in Functional Independence Measure
The Functional Independence Measure (FIM) is an assessment tool that aims to evaluate the functional status of patients throughout the rehabilitation process following a stroke, traumatic brain injury, spinal cord injury or cancer. Higher score means a better outcome. The minimum value is 18, and the maximum value is 126.
Measured: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Changes in Berg balance scale
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities. Higher score means a better outcome. The minimum value is 0, and the maximum value is 56.
Measured: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Changes in Mini Mental State Examination
The Mini-Mental State Examination (MMSE) test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Higher score means a better outcome. The minimum value is 0, and the maximum value is 30.
Measured: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Changes in Self Rating Depression Scale
The Self Rating Depression Scale (SDS) is a psychiatric measuring instrument having descriptive words and phrases that indicate the severity of depression for a time period. Lower score means a better outcome. The minimum value is 20, and the maximum value is 80.
Measured: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Sep 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Society of Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masahiko Hara, Japan Society of Clinical Research
- Investigators
- Masahiko Hara, MD, PhD, Study chair, Cloud Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562662
- Sponsor's protocol ID
- 202001
- Status last verified
- Aug 2022
- First submitted
- 12 Sep 2020
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of mediVR-KAGURA Guided Therapy: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT04562662
- Acronym / sponsor ID
- 202001
- Conditions
- Physical Disability, Cognitive Dysfunction
- Keywords
- Virtual Reality, Physical, Cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Japan Society of Clinical ResearchUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 24 Sep 2020 (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.
The objective is to evaluate mediVR-KAGURA guided therapy for the treatments of physical and cognitive dysfunctions regardless of baseline disease in a prospective interventional design.
Detailed description
The patients sit on an upright chair, wear a head-mounted display (HMD) and grab two handheld controllers in a motion-tracked three-dimensional space called "room scale" of the mediVR-KAGURA (mediVR, Inc. Toyonaka City, Osaka, Japan). mediVR-KAGURA can provide users with >90 frames per second (fps) graphic operation with an approximately 110° viewing angle and accurate three-dimensional tracking technology.
First, we evaluate conventional and maximum reaching distances at 0°, 45°, and 90° level surface for the left hand (0L, 45L, 90L) and at 90°, 135°, and 180° level surface for the right hand (90R, 135R, or 180R) for calibration in a sitting position. During rehabilitation, patients are instructed to touch a fixed objects or catch a falling objects at the pre-specified height and distance levels in each degree. Horizontal distances were classified into three categories, namely long, middle, and short which were calculated using the following formulas: 0.9 * maximum reaching distance, 0.9 * (conventional + maximum reaching distances)/2, and conventional reaching distance respectively. A falling object disappeared at a 20 cm height for safety if the patients missed to catch it. The purpose of reaching hands was to stimulate and break down body trunk balance, and to train participants to balance for stable walking. By thinking about the timing and distance and recognizing the next targets repeatedly, cognitive function was simultaneously stimulated for dual-task training.
The 7 parameters of the rehabilitation programs can be set like as follows: (1) distance (short, middle or long), (2) direction (0L, 45L, 90L, 90R, 135R, or 180R), (3) height of object, (4) size of object (center or outline), (5) size of sensing sphere of the controller, (6) falling speed of the square box (from 0 to 300 cm/s), and (7) intervals for each task. Participants first underwent practical programs to familiarize themselves with mediVR-KAGURA guided rehabilitation, followed by rehabilitation programs. Provision of the rehabilitation programs will be personalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: mediVR KAGURASingle arm (all participants receive interventions) |
Who may qualify
- Ages
- 6 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with physical and/or cognitive dysfunctions
- Agreed to the participation of this study with written informed consent by themselves or guardians
Key exclusion criteria (1 listed)
- 1. Inappropriate candidates at attending physician's discretion
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 |
|---|---|---|
| mediVR KAGURAApproximately 20 min mediVR KAGURA-guided rehabilitation | Device | Intervention group |
Primary outcome
Change in Timed up and go test
Time frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. Shorter score means a better outcome. The minimum value could be 5 seconds or less, and the maximum value could be infinity (cannot complete the test).
Change in Trail Making Test
Time frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
The Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. Shorter score means a better outcome. The minimum value could be 15 seconds or less, and the maximum value could be infinity or be defined as 300 seconds when patients cannot complete the test.
4 secondary outcomes
Changes in Functional Independence Measure
Time frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Changes in Berg balance scale
Time frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Changes in Mini Mental State Examination
Time frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
Changes in Self Rating Depression Scale
Time frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention
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 16 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Masahiko Hara, MD, PhD study chair
Cloud Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediVR KAGURA in people with Physical Disability and Cognitive Dysfunction, run by Japan Society of Clinical Research at 1 site in Japan.
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 2 inclusion and 1 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 16 Aug 2022. 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 Japan. 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 in Timed up and go test (time frame: baseline (pre-intervention), immediately after the first intervention, average of 1, 3 and 6 months after the intervention). The study lists 2 primary outcomes in all. 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 16 Aug 2022.