UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053052 |
|---|---|
| Receipt number | R000060489 |
| Scientific Title | The efficacy of stability ball sitting during tabletop activities for children with sensory processing disorder |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2023/12/11 12:36:31 |
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Basic information
Public title
The influences of an environmental adjustment tool using stability ball chair during tabletop activities for children with sensory processing disorder
Acronym
TIOAEATUSBCDTAFCWSPD
Scientific Title
The efficacy of stability ball sitting during tabletop activities for children with sensory processing disorder
Scientific Title:Acronym
TEOSBSDTAFCWSPD
Region
| Japan | Asia(except Japan) |
Condition
Condition
This study was conducted by comparing the stability ball chair and typical chair for children during tabletop learning activities
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the influences of stability ball sitting during tabletop learning activities for children with sensory problems
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes was the time duration of in-seat (sitting) and on-task (engaging) during sitting on the stability ball chair or typical chair
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Stability ball chair
Interventions/Control_2
Typical chair
Interventions/Control_3
Stability ball chair
Interventions/Control_4
Typical chair
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 7 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
7-10 years old children who has sensory problems condition
Key exclusion criteria
Children who has physical disability, children who has difficulties in understanding the instruction, and children who does not have sensory problems conditions
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Zulfa |
| Middle name | |
| Last name | Khoirunisah |
Organization
Tokyo Metropolitan University
Division name
Master Student in Department of Occupational Therapy
Zip code
116-0012
Address
4-chome-48 Higashiogu, Arakawa City, Tokyo
TEL
09073826778
zulfakhoirunisah@gmail.com
Public contact
Name of contact person
| 1st name | Zulfa |
| Middle name | |
| Last name | Khoirunisah |
Organization
Tokyo Metropolitan University
Division name
Master Student in Depatment of Occupational Therapy
Zip code
116-0012
Address
4 chome 48 Higashiogu, Arakawa City, Tokyo
TEL
09073826778
Homepage URL
zulfakhoirunisah@gmail.com
Sponsor or person
Institute
Asian Human Resource Development Project for Medical Professionals
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
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
Tokyo Metropolitan University
Address
192-0397 Tokyo, Hachioji, Minamiosawa, 1 Chome 1
Tel
0426771111
rinri-hs@tmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
22896710
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
| 2023 | Year | 12 | Month | 12 | 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
35
Results
The results showed that stability ball sitting could improved the in-seat and on-task behavior of children with sensory processing disorder. Stability ball chair is also effective to be used as an environmental adjusment tools during tabletop learning activities.
Results date posted
| 2023 | Year | 12 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline when the participants sit on the chair
Participant flow
The participants sit on the chair and then stability ball then chair and revert again to the stability ball during the four sessions
Adverse events
Outcome measures
Time duration and Goal Attainment Scale (GAS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060489
| Research Plan | |
|---|---|
| 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 |
