UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050459 |
|---|---|
| Receipt number | R000057473 |
| Scientific Title | A non-randomized, controlled study to evaluate the safety and efficacy of night-time postural care with online caregiver support for preventing postural deformities in children with cerebral palsy |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/03/01 19:02:33 |
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Basic information
Public title
Use of night-time postural care with online caregiver support for children with severe cerebral palsy and its effect of preventing postural deformities
Acronym
Evaluating the safety and efficacy of night time postural care for children with severe cerebral palsy
Scientific Title
A non-randomized, controlled study to evaluate the safety and efficacy of night-time postural care with online caregiver support for preventing postural deformities in children with cerebral palsy
Scientific Title:Acronym
Evaluating the safety and efficacy of night time postural care for children with severe cerebral palsy
Region
| Japan |
Condition
Condition
Cerebral palsy
Children with profound intellectual and multiple disabilities
Classification by specialty
| Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the efficacy of night-time postural care for preventing postural deformities in children with severe cerebral palsy. The primary outcome measure is a degree of trunk deformity (lateral flexion and axial rotation angles between the thorax and pelvis). The secondary outcome measures are heart rate and limbs positions during night-time sleep.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Group difference between intervention and control group in the trunk deformity index relative to the baseline value after 3 years
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Night-time postural care, which aims to increase comfort, reduce asymmetry, and improve sleep by using supportive cushions or a mat, is provided every day and continues for up to 3 years.
Interventions/Control_2
Self control
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
| 3 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with movement disorders or cerebral palsy
Gross Motor Function Classification System: 4-5
Key exclusion criteria
Children who have scheduled orthopedic surgery for deformities
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Sato |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
Uyamahigashicho 18-89, Hirakata, Osaka
TEL
072-856-2251
satohar@makino.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Haruhiko |
| Middle name | |
| Last name | Sato |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
Uyamahigashicho 18-89, Hirakata, Osaka
TEL
072-856-2251
Homepage URL
https://square.umin.ac.jp/haru-labo/sleepcare.html
satohar@makino.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Municipal Hirakata child development support center
Hirakata general hospital for developmental disorders
Neyagawa Akatsukihibari-en
Otemae rehabilitation renter for children with physical Disabilities
Shitennoji Yawaragi-en
Todaiji ryoiku hospital for children
Sagamihara ryoiku-en
Centar for developmental disorders of Yokosuka
Tokyo metropolitan Higashiyamato medical center for the severely disabled
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Center for Ethical Review
Address
2-5-1 Shinmachi, Hirakata city, Osaka
Tel
+81-72-804-0101
rinriirb@hirakata.kmu.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
| 2023 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057473
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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