UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055231 |
|---|---|
| Receipt number | R000063089 |
| Scientific Title | Effects of Immersive Virtual Reality Mobility Slit Training on unilateral spatial Neglect - A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/02/12 09:05:04 |
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Basic information
Public title
Effects of Immersive Virtual Reality Mobility Slit Training on unilateral spatial Neglect - A Randomized Controlled Trial
Acronym
Effects of Immersive Virtual Reality Mobility Slit Training on unilateral spatial Neglect - A Randomized Controlled Trial
Scientific Title
Effects of Immersive Virtual Reality Mobility Slit Training on unilateral spatial Neglect - A Randomized Controlled Trial
Scientific Title:Acronym
Effects of Immersive Virtual Reality Mobility Slit Training on unilateral spatial Neglect - A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study, therefore, was to examine the effectiveness of moving slit training, which can train both near and far spatial neglect, using a small head-mounted display (hereafter referred to as HMD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
line bisection test
Key secondary outcomes
line bisection test,Catherine Bergego Scale,3D Ball Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention: 30 minutes of mobility slit training in addition to usual rehabilitation such as ADL training. The training program will consist of 15 minutes of training in the near space and 15 minutes of training in the far space.
Intervention do 2 weeks
Interventions/Control_2
Control group: In addition to usual rehabilitation such as ADL training, visual scanning tasks using paper and objects will be performed for 30 minutes.
Intervention do 2 weeks
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A patient with foci in the right cerebral hemisphere on imaging findin
Patient with a deviation of 15% or more to the right from the midpoint of the line bisection test.
Patient who have had the disease for more than 1 month after the onset.
Key exclusion criteria
A patient with homonymous hemiblindness
Patient who cannot recognize objects in the VR space due to poor vision
Patient who could not give consent for the research
Patient who have difficulty in following due to eye movement paralysis,
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Shuntarou |
| Middle name | |
| Last name | Kawaguchi |
Organization
Sonoda neuro rehabilitetion hospital
Division name
Department of Rehabilitation
Zip code
120-0012
Address
1-10-10 Aoi, Adachi-ku, Tokyo 120-0012, Japan
TEL
0358450126
taro_0128_0112@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shuntarou |
| Middle name | |
| Last name | Kawaguchi |
Organization
Sonoda neuro rehabilitetion hospital
Division name
Department of Rehabilitation
Zip code
120-0012
Address
1-10-10 Aoi, Adachi-ku, Tokyo 120-0012, Japan
TEL
0358450126
Homepage URL
taro_0128_0112@yahoo.co.jp
Sponsor or person
Institute
sonoda neuro rehabilitetion hospital
Institute
Department
Personal name
Funding Source
Organization
sonoda neuro rehabilitetion hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
sonoda institutional review board
Address
1-10-10 Aoi, Adachi-ku, Tokyo 120-0012, Japan
Tel
0358450126
0358311811
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063089
