UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060598 |
|---|---|
| Receipt number | R000069312 |
| Scientific Title | Surf Therapy as a Structured Adaptive Physical Activity Intervention for Japanese Children and Youth with Developmental Disabilities: An Exploratory Pilot Study |
| Date of disclosure of the study information | 2026/02/06 |
| Last modified on | 2026/02/06 11:11:30 |
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Basic information
Public title
Surf therapy and quality of life in Japanese children and youth with developmental disabilities an exploratory pre post pilot study
Acronym
ST-QOL Japan
Scientific Title
Surf Therapy as a Structured Adaptive Physical Activity Intervention for Japanese Children and Youth with Developmental Disabilities: An Exploratory Pilot Study
Scientific Title:Acronym
ST-QOL Japan
Region
| Japan |
Condition
Condition
Neurodevelopmental disorders (including autism spectrum disorder) and Down syndrome with intellectual disability
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to explore, in an exploratory pre post design, the association between participation in an adaptive surf therapy program in Japan and changes in parent proxy health related quality of life and weekly caregiver rated behavioral functioning among children and youth with neurodevelopmental disorders and Down syndrome with intellectual disability. Outcomes are assessed pre intervention, immediately post intervention, and at 1 month follow up.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
ealth-related quality of life (KIDSCREEN27 parent proxy): total raw sum score (27 items; range 27 135) and raw sum scores for five subscales. Time points: pre intervention (Pre), immediately post intervention (Post), and 1 month follow up (1M).
Key secondary outcomes
Weekly caregiver rated behavioral attitudinal/daily rhythm functioning, assessed after each surf therapy session. For exploratory analyses, change is summarized across Time 1 Time 4 among participants attending over 4 sessions.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Adaptive surf therapy program for children and youth with developmental disabilities. The program consisted of six weekly sessions, including health checks, safety briefing, land based warm up and stepwise skill practice, supervised in-water practice, and debriefing. Individualized support was provided, with medical staff on-site for safety back-up.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Parents/guardians of children with intellectual disability and or developmental disabilities who participate in a surf therapy program (6 weekly sessions) delivered by The SCC Surf Therapy Japan
Aged over18 years and able to provide written informed consent
Able to complete questionnaires (KIDSCREEN-27 parent-proxy) at pre post intervention and 1 month follow up, and weekly web based ratings after each session (six assessments)
Key exclusion criteria
Unable to provide written informed consent (parent guardian)
Unable to complete questionnaires (KIDSCREEN27 parent-proxy) and or weekly web-based ratings
The child is deemed unable to participate safely in surf therapy due to medical/safety reasons (e.g., contraindications to physical activity or ocean-based activities)
Withdrawal of consent discontinuation from the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Tsuda |
Organization
Chubu University
Division name
College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
TEL
0568-51-1111
s-tsuda@fsc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Kubota |
Organization
The University of Tokyo Hospital
Division name
Department of Healthcare Information Management
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
09041121050
Homepage URL
kkubota@m.u-tokyo.ac.jp
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
Funding Source
Organization
Chubu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chubu University Ethics Review Committee
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
Tel
0568-51-4672
chubu-rinri@fsc.chubu.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
| 2026 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069312
