UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047037 |
|---|---|
| Receipt number | R000053663 |
| Scientific Title | Investigation of factors related to changes in spatial attention and postural orientation induced by prism adaptation |
| Date of disclosure of the study information | 2022/03/07 |
| Last modified on | 2025/04/09 14:09:38 |
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Basic information
Public title
Investigation of factors related to changes in spatial attention and postural orientation induced by prism adaptation
Acronym
Factors related to changes in spatial attention and postural orientation by prism adaptation
Scientific Title
Investigation of factors related to changes in spatial attention and postural orientation induced by prism adaptation
Scientific Title:Acronym
Factors related to changes in spatial attention and postural orientation by prism adaptation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factors related to changes in spatial attention and postural orientation in the neglect-like phenomena induced by prism adaptation
Basic objectives2
Others
Basic objectives -Others
To investigate the changes in spatial attention and postural orientation and its relationships
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spatial attention
After-effects of prism adaptation
Postural sway
Body verticality
Electromyography
Key secondary outcomes
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
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Normal prism adaptation
Interventions/Control_2
Prism adaptation with different optical deviations
Interventions/Control_3
Prism adaptation on the balance disc
Interventions/Control_4
Prism adaptation with transcranial direct current stimulation at posterior parietal cortex
Interventions/Control_5
Prism adaptation with cerebellar transcranial direct current stimulation
Interventions/Control_6
Prism adaptation with sham stimulation
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Right-hand dominant
Understand the instructions
Key exclusion criteria
Present or history of orthopedic and neurological disorders
Visual field impairment such as strabismus
History of epileptic seizures
Pacemaker in the body
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kitatani |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata, Niigata
TEL
025-257-4309
ryosuke-kitatani@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kitatani |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata, Niigata
TEL
025-257-4309
Homepage URL
ryosuke-kitatani@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethics Committee, Niigata University of Health and Welfare
Address
1398, Shimami-cho, Kita-ku, Niigata, Niigata
Tel
025-257-4455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
89
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 | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053663
