UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037625 |
|---|---|
| Receipt number | R000042888 |
| Scientific Title | Therapeutic application of virtual reality in unilateral spatial neglect patient.-randomized controlled trial- |
| Date of disclosure of the study information | 2019/08/20 |
| Last modified on | 2024/03/04 15:56:41 |
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Basic information
Public title
Therapeutic application of virtual reality in unilateral spatial neglect patient.-randomized controlled trial-
Acronym
Therapeutic application of virtual reality in unilateral spatial neglect patient.-randomized controlled trial-
Scientific Title
Therapeutic application of virtual reality in unilateral spatial neglect patient.-randomized controlled trial-
Scientific Title:Acronym
Therapeutic application of virtual reality in unilateral spatial neglect patient.-randomized controlled trial-
Region
| Japan |
Condition
Condition
unilateral spatial neglect
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Applying virtual reality to rehabilitation of unilateral spatial neglect, and Improving neglect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of correct answers or reaction time of stimulus driven attention test
Key secondary outcomes
Behavioral Inattention Test
Functional Independence Measure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants wore Oculus Go goggle-type HMDs (Meta Platforms, Inc., Menlo Park, CA, USA) and performed the stimulus-response task in a seated position for 3 to 5 minutes. The visual field was shifted each time a new stimulus balloon appeared. Subjects were instructed to return the cursor to the pillar in the center of the VR space until the next stimulus appeared. Thus, as the view of the virtual space moved, the participant's head gradually turned to the left.
This task was performed once a day for five days.
Interventions/Control_2
The task for SR group was a stimulus response without a background shift. The intervention task was performed the same number of times.
Interventions/Control_3
The control task was to keep gazing at the balloon presented in the center of the VR screen. The balloons changed color every few seconds. The duration of the task was 3 min.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First patient with cerebrovascular disorder
Hemispheric lesions
Right handed
Stable nerve findings
Stable vital signs
Holding sit for 10 minutes or more
Key exclusion criteria
Consciousness disorder (<JCS10)
Mental illness or dementia
Visual impairment
Inner ear disease or equilibrium
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Motomura |
Organization
Mishuku Hospital
Division name
Department of rehabilitation
Zip code
1530051
Address
5-33-12 Kamimeguro, Meguro-ward, Tokyo
TEL
08051739422
k.motomura128@gmail.com
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Motomura |
Organization
Mishuku Hospital
Division name
Department of rehabilitation
Zip code
1530051
Address
5-33-12 Kamimeguro, Meguro-ward, Tokyo
TEL
0337115771
Homepage URL
k.motomura128@gmail.com
Sponsor or person
Institute
other
Mishuku Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Mishuku Hospital
Address
5-33-12 Kamimeguro, Meguro-ward, Tokyo
Tel
0337115771
k.motomura128@gmail.com
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
国家公務員共済組合連合会三宿病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000042888
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000042888
Number of participants that the trial has enrolled
42
Results
The results of the two-way ANOVA of the SAT showed an interaction between the left-2 and right+2. A simple main effect of SR + BS on the other two groups was shown for left-2 (p<0.01, Cohen's d: 0.48), but not for right+2 (p=0.10, Cohen's d: 0.23).
Results date posted
| 2024 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 889 patients were screened between May 2020 and June 2023. Forty-two participants met the inclusion criteria and provided written informed consent to participate in the study.
Participant flow
We randomly assigned 14 of the 42 participants to the SR + BS, SR, and control groups. Follow-up data were not available for one participant each in SR group and control group because of transfer to other hospitals. The baseline data of the participants are shown in Table 1. No significant differences were observed in variables collected during the baseline period. No adverse events were recorded for any participant.
Adverse events
Nothing
Outcome measures
Stimulus-driven attention test (SAT)
Straight ahead pointing (SAP)
Behavioral Intention Test(BIT-c)
Catherine Bergego Scale(CBS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042888
