UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045242 |
|---|---|
| Receipt number | R000051663 |
| Scientific Title | Effect of prism adaptation of 3D virtual reality on patients with left unilateral spatial neglect ~ Randomized controlled trial ~ |
| Date of disclosure of the study information | 2021/08/30 |
| Last modified on | 2024/09/09 17:34:51 |
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Basic information
Public title
Effect of prism adaptation of 3D virtual reality on patients with left unilateral spatial neglect
~ Randomized controlled trial ~
Acronym
Effect of prism adaptation of 3D virtual reality on patients with left unilateral spatial neglect
~ Randomized controlled trial ~
Scientific Title
Effect of prism adaptation of 3D virtual reality on patients with left unilateral spatial neglect
~ Randomized controlled trial ~
Scientific Title:Acronym
Effect of prism adaptation of 3D virtual reality on patients with left unilateral spatial neglect
~ Randomized controlled trial ~
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effect of a single session of prism adaptation using VR on left unilateral spatial neglect by a randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral inattention test Japanese version of normal inspection (BIT-C)
Key secondary outcomes
open loop pointing task
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Regular rehabilitation and Use a fully immersive VR prism adaptation system.The prism shifts to the right by 20 diopters.
Quickly repeat the reach toward the target displayed in VR.
Reach operation is about 100 times. Single session intervention.
Interventions/Control_2
It uses normal rehabilitation and a prism adaptation system using fully immersive VR, but there is no prism shift. This is a task that appears in VR and quickly repeats the reach movement towards the target.
Reach operation is about 100 times. Single session intervention.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Right cerebral hemisphere injury
(2) Hospitalization within 2 to 6 months after the onset of stroke,
(3) 20-90 years old,
(4) No severe cognitive impairment (MMSE> 15 points),
(5) At least one item BIT-C, so less than the cutoff value,
Or, 1 point or more on CBS
Key exclusion criteria
(1) People with lesions under the cerebellar tentorium,
(2) Visually impaired,
(3) Hearing impaired,
(4) People with severe movement disorders or difficulty reaching the right upper limb,
(5) People who cannot understand the task due to aphasia or other cognitive impairment.
(6) Defect in the position of the right finger due to peripheral neuropathy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
Kumamoto health Science University
Division name
Faculty of Health Science
Zip code
861-5598
Address
325 Izumi-machi Kita-ku Kumamoto City, Japan
TEL
096-275-2111
matsuo-ta@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
Kumamoto health Science University
Division name
Faculty of Health Science
Zip code
861-5598
Address
325 Izumi-machi Kita-ku Kumamoto City, Japan
TEL
096-275-2111
Homepage URL
matsuo-ta@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto health Science University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagasaki University Graduate School of Biomedical Science
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto health Science University life science Ethics Review Board
Address
325 Izumi-machi Kita-ku Kumamoto City, Japan
Tel
096-275-2112
kikaku@kumamoto-hsu.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
桜十字福岡病院（福岡県），新武雄病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 30 | 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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051663
