UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026786 |
|---|---|
| Receipt number | R000030676 |
| Scientific Title | The effects of sensory integration therapy on children with developmental disorders |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2019/10/01 19:19:53 |
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Basic information
Public title
The effects of sensory integration therapy on children with developmental disorders
Acronym
The effects of sensory integration therapy on children with developmental disorders
Scientific Title
The effects of sensory integration therapy on children with developmental disorders
Scientific Title:Acronym
The effects of sensory integration therapy on children with developmental disorders
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Attention Deficit Hyperactivity Disorder
Developmental Coordination Disorder
Communication Disability
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effectiveness of sensory integration therapy in improving sense, motor function, dyspraxia in nonrandomized comparative test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the Japanese Playful Assessment for Neuropshychological Abilities short version (S-JPAN)
Key secondary outcomes
sensory profile short version
Drow a Man test (DAM)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention period: 10 months
Intervention amount: 40 minutes per one time
Number of interventions: 20 times
Intervention frequency: once per 2 weeks
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
| 5 | years-old | <= |
Age-upper limit
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 5 to 8 years old, S-JPAN figures should be 0.55 or more.
Key exclusion criteria
Children aged 5 to 8 years old should have a S-JPAN figure of less than 0.55.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Morikawa |
Organization
Kawasaki Junior College of Rehabilitaiton
Division name
Department of Occupational Therapy
Zip code
701-0192
Address
672, Matsushima, Kurashiki city, Okayama prefecture
TEL
086-462-1111
morikawa@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Morikawa |
Organization
Kawasaki Junior College of Rehabilitaiton
Division name
Department of Occupational Therapy
Zip code
701-0192
Address
672, Matsushima, Kurashiki city, Okayama prefecture
TEL
086-462-1111
Homepage URL
morikawa@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Junior College of Rehabilitaiton
Department of Occupational Therapy
Institute
Department
Personal name
Funding Source
Organization
none
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
Kawasaki Junior College of Rehabilitaiton
Address
672, Matsushima, Kurashiki city, Okayama prefecture
Tel
0864621111
morikawa@med.kawasaki-m.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
| 2017 | Year | 03 | Month | 30 | 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
15
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
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030676
| Research Plan | |
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| 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 |
