UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060934 |
|---|---|
| Receipt number | R000069732 |
| Scientific Title | Development of an Exercise Evaluation Program Using Virtual Reality Devices for Unilateral Spatial Neglect |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/14 11:01:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of an Exercise Evaluation Program Using Virtual Reality Devices for Unilateral Spatial Neglect
Acronym
Development of an Exercise Evaluation Program Using Virtual Reality Devices for Unilateral Spatial Neglect
Scientific Title
Development of an Exercise Evaluation Program Using Virtual Reality Devices for Unilateral Spatial Neglect
Scientific Title:Acronym
Development of an Exercise Evaluation Program Using Virtual Reality Devices for Unilateral Spatial Neglect
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the VR program we developed for USN is capable of evaluating USN just as effectively as conventional methods
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The angle of afterimage immediately following the completion of 30 prism adaptation trials, as measured using the newly developed method and the conventional method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will perform all three sets of VR programs in the assigned order. Each session lasts approximately 10 minutes. A washout period of at least 48 hours is observed between sessions. The intervention consists of a total of three sessions. The VR equipment used will be Vi-dere (Sysnet). This is a VR device approved as a medical device for USN assessment and training. Participants will wear VR goggles while seated in a chair. The surrounding environment will be designed so that there are no objects within the participants reach.
Basic Task:
Upon putting on the VR headset, participants can see the target object displayed within the VR space. Note that no objects other than the target are placed in the VR space. Participants hold the controller in their right (or left) hand, raise it above their head, and then perform a reaching movement toward the target object. The target disappears upon contact and reappears when the participant raises their hand above their head again. The target is positioned in one of three locations: front, right, or left. Visual deviation caused by the prism is uniformly set to 10 degrees to the right.
Three Sets to Be Performed:
Set 1 (Conventional Method Evaluation After 20 PA Trials):
After performing 20 reaching trials with the prism (with the visual field shifted 10 degrees to the right), perform one reaching trial without the prism (with no visual field shift) on the 21st trial.
After that, perform 10 reaching trials with the prism (for a total of 30 PA trials), followed by one reaching trial without the prism.
Interventions/Control_2
Set 2 (Conventional Method Evaluation after 30 PA trials):
After performing 30 reaching trials with the prism, perform one reaching trial without the prism on the 31st trial.
Interventions/Control_3
Set 3 (New Method Continuous Evaluation):
Perform 33 consecutive reaching trials with the prism. During this sequence, the 11th, 22nd, and 33rd trials are switched to evaluation trials without the prism.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals with no history of stroke or higher brain dysfunction.
Individuals who have provided written consent to participate in the study.
Individuals aged 20 to 80 years old on the date consent is obtained (gender is not a factor).
Individuals capable of understanding and following the instructions presented within the VR environment by the researcher.
Key exclusion criteria
Individuals with a history of stroke.
Individuals diagnosed with unilateral spatial neglect.
Individuals with cognitive impairments that make it difficult to understand the study instructions.
Individuals with upper limb paralysis, limited joint range of motion, or ataxia that would interfere with the performance of the reaching task.
Individuals with severe visual impairment (uncorrectable) that affects task performance.
Individuals who have previously experienced severe motion sickness or intense discomfort from VR use.
Individuals who experienced intense discomfort during the trial VR session.
Any other individuals deemed unsuitable for the study by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Kagoshima University
Division name
Rehabilitation Medicine
Zip code
890-8520
Address
35-1 Sakuragaoka 8-chome, Kagoshima City
TEL
099-275-5339
k0720622@kadai.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Kagoshima University
Division name
Rehabilitation Medicine
Zip code
890-8520
Address
35-1 Sakuragaoka 8-chome, Kagoshima City
TEL
099-275-5339
Homepage URL
k0720622@kadai.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee on Clinical Research, Sakuragaoka Campus, Kagoshima University
Address
35-1 Sakuragaoka 8-chome, Kagoshima City
Tel
099-275-5354
crmc@m2.kufm.kagoshima-u.ac.jp)
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 14 | Day |
Last modified on
| 2026 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069732
