UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048751 |
|---|---|
| Receipt number | R000055506 |
| Scientific Title | Investigation of prism adaptation method using VR |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2023/08/07 14:42:58 |
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Basic information
Public title
Investigation of prism adaptation method using VR
Acronym
Investigation of prism adaptation method using VR
Scientific Title
Investigation of prism adaptation method using VR
Scientific Title:Acronym
Investigation of prism adaptation method using VR
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how the different number of targets in prismatic adaptation therapy affects the degree of adaptation and the adaptation process.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Manual Straight Ahead
Before and after intervention and After 2 hours
Key secondary outcomes
Adaptation Index
Before and after intervention and After 2 hours
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The declination of the PA task was set at approximately 10 degrees to the right. Subjects were asked to perform 100 trials of pointing to a single target in the frontal plane. They also performed 30 pointing trials each with no deviation angle before and after the PA task.
Interventions/Control_2
The declination angle of the PA task was set at approximately 10 degrees to the right. Subjects performed 100 trials of pointing to the two targets on the left and right. Before and after the PA task, subjects also performed 30 pointing trials with no deviation angle set before and after the PA task.
Interventions/Control_3
The declination angle for the PA task was set at approximately 10 degrees to the right. Subjects were asked to perform 100 pointing trials to three targets in front and to the left and right. Before and after the PA task, in which no deviation angle was set, subjects performed 30 pointing trials each.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Right-handed normal adult
Key exclusion criteria
1) visual impairment, 2) cerebrovascular disease, 3) significant motor system disease in the right upper extremity
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
Kumamoto Health Sciences University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumimachi,Kitaku,Kumamoto to city,Japan
TEL
0962752111
matsuo-ta@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Matsuo |
Organization
Kumamoto Health Sciences University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumimachi,Kitaku,Kumamoto to city,Japan
TEL
0962752111
Homepage URL
matsuo-ta@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Sciences University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Sciences University
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
Kumamoto Health Science University Life Science Ethics Review Board
Address
325 Izumimachi,Kitaku,Kumamoto to city,Japan
Tel
0962752111
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）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 25 | 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
57
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
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 12 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055506
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
