UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058985 |
|---|---|
| Receipt number | R000067257 |
| Scientific Title | Immediate Effects of Rebound Exercise on Postural Control in Children with Down Syndrome |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/09/04 09:32:24 |
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Basic information
Public title
Immediate Effects of Rebound Exercise on Postural Control in Children with Down Syndrome
Acronym
Immediate Effects of Rebound Exercise on Postural Control in Children with Down Syndrome
Scientific Title
Immediate Effects of Rebound Exercise on Postural Control in Children with Down Syndrome
Scientific Title:Acronym
Immediate Effects of Rebound Exercise on Postural Control in Children with Down Syndrome
Region
| Japan |
Condition
Condition
down syndrome
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the immediate effects of rebound exercise on postural control in children with Down syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postural sway before and after rebound exercise (total trajectory length of the center of pressure)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1 minute of rebound exercise on a trampoline -> 1-week washout period -> 1 minute of quiet rest
Interventions/Control_2
1 minute of quiet rest -> 1-week washout period -> 1 minute of rebound exercise on a trampoline
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
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 6-18 years, male or female, with a medical diagnosis of Down syndrome
Able to maintain an independent sitting posture
Able to understand and follow basic instructions
Key exclusion criteria
Presence of epilepsy
Presence of atlantoaxial instability
Uncorrected visual or hearing impairments
Uncorrected congenital heart disease without medical clearance for exercise
History of lower extremity musculoskeletal surgery within the past year
Presence of scoliosis
Inability of the legal guardian to sufficiently understand the study
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Aoyama |
Organization
Kyoto University, Graduate School of Medicine, Department of Human Health Science
Division name
Course of Advanced Rehabilitation Sciences Majored in Advanced Physical Therapy
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3952
aoyama.tomoki.4e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Otsubo |
Organization
Kyoto University, Graduate School of Medicine, Department of Human Health Science
Division name
Course of Advanced Rehabilitation Sciences Majored in Advanced Physical Therapy
Zip code
606-8395
Address
502, Rajjinguhouse RanII, 29, Kawabatadorihigashiiruhigashimarutamati, Sakyo-ward, Kyoto-city, Kyoto
TEL
090-8181-9652
Homepage URL
otsubo.ryunosuke.78v@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Graduate School of Medicine, Department of Human Health Science
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Konoe-cho, Sakyo-ward, Kyoto-city
Tel
075-753-4680
ethcom@kuhp.kyoto-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 | 09 | Month | 05 | 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
| 2025 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 05 | 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
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067257
