UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037263
Receipt number R000042485
Scientific Title The effects of sensory integration therapy for children with Developmental Coordination Disorder
Date of disclosure of the study information 2019/07/03
Last modified on 2020/06/15 12:16:02

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Basic information

Public title

The effects of sensory integration therapy for children with Developmental Coordination Disorder

Acronym

The effects of sensory integration therapy for children with Developmental Coordination Disorder

Scientific Title

The effects of sensory integration therapy for children with Developmental Coordination Disorder

Scientific Title:Acronym

The effects of sensory integration therapy for children with Developmental Coordination Disorder

Region

Japan


Condition

Condition

Developmental Coordination Disorder

Classification by specialty

Pediatrics Psychiatry Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of the sensory integration therapy for children with Developmental Coordination Disorders.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Movement Assessment Battery for Children -Second Edition(M-ABC2)

Key secondary outcomes

1)Southern California Sensory Integration Test
2)Canadian Occupational Performance Measure(COPM)
3)The Japanese version of Developmental Coordination Disorder Questionnaire
5)Short Sensory Profile
6)ADHD-RS-4
7)Social Responsiveness Scale Second Edition


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Participants will receive sessions of sensory integration therapy (Ayres Sensory Integration Therapy)
Intervention period: 10 weeks
Intervention amount: 60 minutes per one time
Number of interventions: 20 times
Intervention frequency: once per 2 weeks

Interventions/Control_2

1)Not receive Sensory Integration therapy
2)Only usual care service

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

4 years-old <=

Age-upper limit

8 years-old >

Gender

Male and Female

Key inclusion criteria

1)Have a diagnosis of DCD
2)full scale IQ higher than 70
3)SCSIT subtests score of <-0.7 SD on 3 or more
4)has attained percentile rank 15 on MABC2 total test score or any components
5)using the child development support project, after-school day service

Key exclusion criteria

1)Cerebral palsy
2)Neuro muscle disorder
3)Participants had experience of a sensory integration therapy in the past

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yoko
Middle name
Last name Sato

Organization

Prefectural University of Hiroshima

Division name

Department of Occupational Therapy, Faculty of Health and Welfare

Zip code

7230053

Address

1-1 Gakuen-cho, Mihara City, Hiroshima,Japan

TEL

0848-60-1245

Email

yokodomot@gmail.com


Public contact

Name of contact person

1st name Yoko
Middle name
Last name Sato

Organization

Prefectural University of Hiroshima

Division name

Department of Occupational Therapy, Faculty of Health and Welfare

Zip code

7230053

Address

1-1 Gakuen-cho, Mihara City, Hiroshima,Japan

TEL

0848-60-1245

Homepage URL


Email

yokodomot@gmail.com


Sponsor or person

Institute

Prefectural University of Hiroshima

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of the Prefectural University of Hiroshima

Address

1-1 Gakuen-cho, Mihara City, Hiroshima,Japan

Tel

0848-60-1120

Email

yokodomot@gmail.com


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 07 Month 03 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

17

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 03 Month 07 Day

Date of IRB

2019 Year 06 Month 28 Day

Anticipated trial start date

2019 Year 07 Month 04 Day

Last follow-up date

2020 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

2019 Year 07 Month 03 Day

Last modified on

2020 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042485


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name