UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038012 |
|---|---|
| Receipt number | R000043329 |
| Scientific Title | Sense of agency and effect of subthreshold vibrotactile noise stimulation in developmental coordination disorder |
| Date of disclosure of the study information | 2019/09/13 |
| Last modified on | 2020/01/15 21:52:00 |
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Basic information
Public title
Sense of agency and effect of subthreshold vibrotactile noise stimulation in developmental coordination disorder
Acronym
SoA and effect of SR in DCD
Scientific Title
Sense of agency and effect of subthreshold vibrotactile noise stimulation in developmental coordination disorder
Scientific Title:Acronym
SoA and effect of SR in DCD
Region
| Japan |
Condition
Condition
Developmental Coordination Disorder
Classification by specialty
| Pediatrics | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantitative evaluation of sense of agency and verification of effect of subthreshold vibrotactile noise stimulation in developmental coordination disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sense of agency(agency attribution task)
motor function(movement-ABC2)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
subthreshold vibrotactile noise stimulation(implementation order:on-off-on-off).
On-condition in interventions 1 and 2.
Compare between on- and off-conditions.
Interventions/Control_2
subthreshold vibrotactile noise stimulation(implementation order:off-on-off-on).
Off-condition in interventions 1 and 2.
Compare between on- and off-conditions.
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
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Standard development children and developmental coordination disorder's children in 6-15 years old.
Key exclusion criteria
Children has the motor disfunction by cerebral palsy and other injuries.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | satoshi |
| Middle name | |
| Last name | nobusako |
Organization
Kio University
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
s.nobusako@kio.ac.jp
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | nobusako |
Organization
Kio University
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
s.nobusako@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Kio University Ethics Committee
Address
4-2-2, Umaminaka, Koryo-cho, Kitakaturagi-gun, Nara, Japan
Tel
0745541601
s.nobusako@kio.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
| 2019 | Year | 09 | Month | 13 | 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
| 2019 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043329
| 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 |
