UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062902 |
|---|---|
| Receipt number | R000071748 |
| Scientific Title | An Exploratory Study of the CO-OP Approach in a Regional Hospital: Effects, Generalization to Home and School, and Perspectives of Families and Teachers |
| Date of disclosure of the study information | 2026/09/14 |
| Last modified on | 2026/09/13 16:14:12 |
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Basic information
Public title
An Exploratory Study of the CO-OP Approach in a Regional Hospital: Effects, Generalization to Home and School, and Perspectives of Families and Teachers
Acronym
CO-OP Approach Study in a Regional Hospital
Scientific Title
An Exploratory Study of the CO-OP Approach in a Regional Hospital: Effects, Generalization to Home and School, and Perspectives of Families and Teachers
Scientific Title:Acronym
CO-OP Approach Study in a Regional Hospital
Region
| Japan |
Condition
Condition
Developmental disorders
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the feasibility of implementing the CO-OP approach for school-aged children with developmental characteristics in a regional hospital, and to explore changes following the intervention, including how the skills and problem-solving framework acquired through the intervention are applied in daily life at home and school, as well as experiences of collaboration with educational institutions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Canadian Occupational Performance Measure(COPM)
Performance Quality Rating Scale(PQRS)
Assessment time points: Before and after the intervention
Key secondary outcomes
Developmental Coordination Disorder Questionnaire, Motor Observation Questionnaire for Teachers, Strength and Difficulties Questionnaire, Interviews with parents and teachers
Assessment time points: Questionnaires were administered before and after the intervention; interviews were conducted after completion of the intervention.
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
| Maneuver |
Interventions/Control_1
The CO-OP approach will be provided for 60 minutes per session, approximately twice a month, for a total of 10 sessions, to support participants in achieving three self-selected goals.
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
| 6 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Target child
School aged children aged 6 to 15 years with developmental characteristics and difficulties in motor coordination, whose parents provide informed consent and who provide assent to participate in the study.
Target person
Parents and teachers of eligible children who provide informed consent to participate in the study.
Key exclusion criteria
Target child
Children who have an IQ below 70 on the WISC-V, whose motor difficulties are attributable to underlying conditions such as neuromuscular or degenerative diseases, who have difficulty understanding instructions necessary to perform the tasks, whom the attending physician determines to be unable to participate in the study, or who are continuously receiving occupational therapy at another institution.
Target person
Those who have difficulty completing the questionnaires or participating in the interviews.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Toeda |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8511
Address
3-39-22 Syowa-machi, Maebashi-City
TEL
027-220-8953
to.haruka@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Toeda |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8511
Address
3-39-22 Syowa-machi, Maebashi-City
TEL
027-220-8953
Homepage URL
to.haruka@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Gunma University
Address
3-39-22 Syowa-machi, Maebashi-City
Tel
027-220-8953
to.haruka@gunma-u.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 | 09 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2031 | 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
| 2026 | Year | 09 | Month | 13 | Day |
Last modified on
| 2026 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071748
