UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051849 |
|---|---|
| Receipt number | R000059161 |
| Scientific Title | Using Virtual Reality with Normal Adults Effects of Left-biased Prism Adaptation on Language Fluency |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2024/09/09 17:35:46 |
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Basic information
Public title
Using Virtual Reality with Normal Adults Effects of Left-biased Prism Adaptation on Language Fluency
Acronym
Using Virtual Reality with Normal Adults Effects of Left-biased Prism Adaptation on Language Fluency
Scientific Title
Using Virtual Reality with Normal Adults Effects of Left-biased Prism Adaptation on Language Fluency
Scientific Title:Acronym
Using Virtual Reality with Normal Adults Effects of Left-biased Prism Adaptation on Language Fluency
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An experimental study to examine the effects of VR-based prism adaptation on verbal fluency tasks in healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Language fluency task
Key secondary outcomes
Manual Straight Ahead
Visual Attention-Response Task
Adaptability index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After assessing the primary and secondary outcomes, a prism adaptation system using a fully immersive VR was used. The prism is shifted 20 diopters to the left and the task is to repeat a rapid reaching movement to the target shown in the VR approximately 100 times.
Interventions/Control_2
After assessing the primary and secondary outcomes, a prism adaptation system using a fully immersive VR was used. The prism is shifted 20 diopters to the right and the task is to repeat a rapid reaching movement to the target shown in the VR approximately 100 times.
Interventions/Control_3
After assessing the primary and secondary outcomes, a prism adaptation system was used with a fully immersive VR but without prism shift; the task was to repeat a fast reaching movement to a target shown in the VR approximately 100 times.
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Right-handed healthy adults
Key exclusion criteria
(1) Persons with visual impairment.
(2) Persons with a history of cerebrovascular disease.
(3) Persons with a history of significant musculoskeletal disorders of the upper limb.
Target sample size
69
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
KUMAMOTO health Science university
Division name
Department of Rehabilitation
Zip code
861-5598
Address
325 Izumi-machi,kita-ku,kumamoto japan
TEL
096-275-2283
m.takashi0627@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
KUMAMOTO health Science university
Division name
Department of Rehabilitation
Zip code
861-5598
Address
325 Izumi-machi,kita-ku,kumamoto japan
TEL
096-275-2283
Homepage URL
m.takashi0627@gmail.com
Sponsor or person
Institute
KUMAMOTO health Science university
Institute
Department
Personal name
Takashi Matsuo
Funding Source
Organization
Grant-in-Aid for Scientific Research(C)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto health Science university
Address
325 Izumi-machi,kita-ku,kumamoto 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
熊本保健科学大学（熊本県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 07 | 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
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 08 | Month | 07 | 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=R000059161
