UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055328 |
|---|---|
| Receipt number | R000063227 |
| Scientific Title | Establish an optimal method for assessing tactile orientation discrimination. |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/08/24 15:07:23 |
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Basic information
Public title
Establish an optimal method for assessing tactile orientation discrimination.
Acronym
Establish an optimal method for assessing tactile orientation discrimination.
Scientific Title
Establish an optimal method for assessing tactile orientation discrimination.
Scientific Title:Acronym
Establish an optimal method for assessing tactile orientation discrimination.
Region
| Japan |
Condition
Condition
healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the optimal stimulus speed and stimulus block pressure for assessing tactile orientation discrimination ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tactile grating orientation discrimination ability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
128 tactile orientation discrimination tasks (stimulus speed: 10 mm/s).
Interventions/Control_2
128 tactile orientation discrimination tasks (stimulus speed: 15 mm/s).
Interventions/Control_3
128 tactile orientation discrimination tasks (stimulus speed: 20 mm/s).
Interventions/Control_4
128 tactile orientation discrimination tasks (stimulus block press force: 4 N).
Interventions/Control_5
128 tactile orientation discrimination tasks (stimulus block press force: 7 N).
Interventions/Control_6
128 tactile orientation discrimination tasks (stimulus block press force: 10 N).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy persons at aged 18-50 y.o.
Key exclusion criteria
Neurological and psychiatric disorders and history of such disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Saito |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252501954
kei-saito@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Saito |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
0252501954
Homepage URL
kei-saito@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-shi, 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
| 2024 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | 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
Management information
Registered date
| 2024 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063227
