UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055795 |
|---|---|
| Receipt number | R000063530 |
| Scientific Title | Effectiveness of Teaching Children Self-Directed Rehabilitation Training on the Mental and Physical Functioning of Long-Term Hospitalized Children: A Multicenter Study |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2024/11/14 11:53:51 |
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Basic information
Public title
Effectiveness of Teaching Children Self-Directed Rehabilitation Training on the Mental and Physical Functioning of Long-Term Hospitalized Children: A Multicenter Study
Acronym
Effectiveness of Self-Directed Rehabilitation Training Instruction on Mental and Physical Functioning of Long-Term Hospitalized Children
Scientific Title
Effectiveness of Teaching Children Self-Directed Rehabilitation Training on the Mental and Physical Functioning of Long-Term Hospitalized Children: A Multicenter Study
Scientific Title:Acronym
Effectiveness of Self-Directed Rehabilitation Training Instruction on Mental and Physical Functioning of Long-Term Hospitalized Children
Region
| Japan |
Condition
Condition
disuse syndrome
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Mission X is considered suitable as an exercise program for long-term hospitalized children because (1) it is a comprehensive learning program on the theme of space exploration and (2) it is a free, semi-public program. Therefore, we planned to investigate how the Mission X program affects the activity level and mental health of long-term hospitalized children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
9 minutes walk test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group will be introduced to Mission X and instructed to perform Mission X for at least 20 minutes per day. 5 activities in Mission X will be selected that can be practiced with hospitalized children.The intervention group will be instructed to aim for at least 20 minutes per day.
Interventions/Control_2
The control group is introduced to the usual self-program.The control group will be instructed to aim for at least 20 minutes per day.
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
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The target population will be children at high risk of inactivity who are referred to the rehabilitation department by their primary department, such as pediatrics, for evaluation of the need for medical rehabilitation. Indications will be determined separately from medical rehabilitation, and additional research interventions will be implemented after explanation and consent. Inclusion criteria are (1) age 4-14 years, (2) with medical rehabilitation intervention, and (3) with Internet access.
Key exclusion criteria
Exclusion criteria are (1) intellectual problems that make it difficult for the patient to perform the Mission X program or independent training, and (2) general condition that does not allow the patient to perform the task.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yamada |
| Middle name | |
| Last name | Shin |
Organization
Kyorin University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
181-0004
Address
Tokyo, Mitaka, Shinkawa 6-20-2
TEL
0422475511
yamada-shin@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidaka |
| Middle name | |
| Last name | Rei |
Organization
Kyorin University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
181-0004
Address
Tokyo, Mitaka, Shinkawa 6-20-2
TEL
0422475511
Homepage URL
rei-hidaka@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
Tokyo, Mitaka, Shinkawa 6-20-2
Tel
0422-47-5511
rec@ks.kyorin-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
| 2025 | Year | 11 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063530
