UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051022 |
|---|---|
| Receipt number | R000058161 |
| Scientific Title | Change in electroencephalograms related to conscious postural compensation in healthy adults |
| Date of disclosure of the study information | 2023/05/10 |
| Last modified on | 2023/05/10 08:44:26 |
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Basic information
Public title
Cortical activity associated with postural control in healthy adults
Acronym
Cortical activity associated with postural control
Scientific Title
Change in electroencephalograms related to conscious postural compensation in healthy adults
Scientific Title:Acronym
Change in electroencephalograms related to conscious postural compensation
Region
| Japan |
Condition
Condition
Non
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
From the viewpoint of electroencephalogram analysis, we will clarify changes in cerebral cortical activity when participants are placed in an environment where posture should be consciously controlled.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of pressure
Electroencephalogram
Gaze point
Sole pressure
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 19 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
College students
Key exclusion criteria
Those with a history of neurological disease
Those with a history of orthopedic diseases
Those with severe visual impairment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ohgomori |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka, Osaka
TEL
072-446-6700
ohgomorit@kawasakigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Futoshi |
| Middle name | |
| Last name | Kawase |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Research support section
Zip code
597-0104
Address
158 Mizuma, Kaizuka, Osaka
TEL
072-446-6700
Homepage URL
soumu@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
Funding Source
Organization
Osaka Kawasaki Rehabilitation 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
Osaka Kawasaki Rehabilitation University
Address
158 Mizuma, Kaizuka, Osaka
Tel
072-446-6700
ohgomorit@kawasakigakuen.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
| 2023 | Year | 05 | Month | 10 | 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
| 2023 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study. Participants will perform postural control tasks with different degrees of difficulty, and changes in body sway and electroencephalograms will be measured.
Management information
Registered date
| 2023 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058161
| Research Plan | |
|---|---|
| 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 |
