UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034308 |
|---|---|
| Receipt number | R000039113 |
| Scientific Title | An interventional study regarding usefulness of the evaluation of developmental cordination disorder as an diagnostic marker of infants' developmental disorders |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2020/03/30 11:16:01 |
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Basic information
Public title
An interventional study regarding usefulness of the evaluation of developmental cordination disorder as an diagnostic marker of infants' developmental disorders
Acronym
Developmental disorders and developmental cordination disorder among infants
Scientific Title
An interventional study regarding usefulness of the evaluation of developmental cordination disorder as an diagnostic marker of infants' developmental disorders
Scientific Title:Acronym
Developmental disorders and developmental cordination disorder among infants
Region
| Japan |
Condition
Condition
Developmental disorders, developmental cordination disorder
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the asscoiation between developmental disorders and developmental cordination disorder among infants
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Developmental cordination disorder among infants aged 3 to 5 years old
Key secondary outcomes
a tendency of developmental disorders evaluated by mothers and teachers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
occupational and speech therapists conduct type N infants cordination eveluation test (30 minutes) and record the infants' movement by monitor
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
| 3 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. new outpatients of Aitoku Welfare Hospital, Wakayama, Japan
2. infants aged 3 to 5 years
3. infants in nursery school or kindergarten
4. infants with diagnosed or suspected developmental disorders
5. infants with mothers when atteng a hospital
6. infants to receive an order of occcupational or speech therapy by physician in charge
Key exclusion criteria
1. heavy motor dysfunction such as injury or cerebral palsy
2. when physician in charge decide the subjects are not suitable for participating in the study due to their physical or mental problems
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kouichi |
| Middle name | |
| Last name | Yoshimasu |
Organization
Wakayama Medical University
Division name
Department of Hygiene, School of Medicine
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama
TEL
073-441-0646
kyoshi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kouichi |
| Middle name | |
| Last name | Yoshimasu |
Organization
Wakayama Medical University
Division name
Department of Hygiene, School of Medicine
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama
TEL
073-441-0646
Homepage URL
kyoshi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Department of Hygiene, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aitoku Medical and Welfare Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University Institutional Review Board
Address
811-1, Kimiidera, Wakayama, Japan
Tel
073-441-0896
wa-rinri@wakayama-med.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
| 2018 | Year | 10 | 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
| 2018 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 28 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039113
