UMIN-CTR Clinical Trial

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
Email	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
Email	kyoshi@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University Department of Hygiene, School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039113