UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053208 |
|---|---|
| Receipt number | R000060672 |
| Scientific Title | Study of preventing scoliosis through rehabilitation focusing on postural management for early-onset scoliosis in infants with severe spinal muscular atrophy treated after onset. |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/06/22 14:22:03 |
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Basic information
Public title
Study of preventing scoliosis through rehabilitation focusing on postural management for early-onset scoliosis in infants with severe spinal muscular atrophy treated after onset.
Acronym
Study of preventing scoliosis through rehabilitation in infants with severe form of spinal muscular atrophy
Scientific Title
Study of preventing scoliosis through rehabilitation focusing on postural management for early-onset scoliosis in infants with severe spinal muscular atrophy treated after onset.
Scientific Title:Acronym
Study of preventing scoliosis through rehabilitation in infants with severe form of spinal muscular atrophy
Region
| Japan |
Condition
Condition
spinal musucular atrophy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify whether scoliosis that develops in early infancy can be prevented through rehabilitation in patients with severe form of spinal musucular atrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of scoliosis at 24 months of age
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Physical therapy at least once every two weeks. The physical therapy mainly pays attention to the following two points, 1.Avoiding independent sitting in situations where sufficient muscle strength has not developed. 2. Actively takeing an anti-gravity position with the support of a physical therapist.
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
| Not applicable |
Age-upper limit
| 8 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with spinal muscular atrophy that had symptoms at the neonatal or early infancy and treated within 6 months of age
Key exclusion criteria
Parents and their child who do not have written consent for this study.
Cases with severe scoliosis (Cobb angle 30 degree or more) at the registration.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Kimizu |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Pediatric Neurology
Zip code
5941101
Address
840 Murodo-cho, Izumi, Osaka
TEL
0725561220
kimizu@wch.opho.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Kimizu |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Pediatric Neurology
Zip code
5941101
Address
840 Murodo-cho, Izumi, Osaka
TEL
0725561220
Homepage URL
kimizu@wch.opho.jp
Sponsor or person
Institute
Osaka Women's and Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Women's and Children's Hospital
Address
840 Murodo-cho, Izumi, Osaka
Tel
0725561220
kimizu@wch.opho.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
| 2024 | Year | 02 | Month | 01 | 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
| 2023 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2033 | 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
| 2023 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060672
