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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039113


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name