UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036470 |
|---|---|
| Receipt number | R000041561 |
| Scientific Title | Randomized control trial |
| Date of disclosure of the study information | 2019/04/11 |
| Last modified on | 2019/04/11 10:05:13 |
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Basic information
Public title
The change after home-based training for children with cerebral palsy
Acronym
Children who conduct home-based training was selected randomly and then the data of them are compaired with that of no home-based training.
Scientific Title
Randomized control trial
Scientific Title:Acronym
RCT
Region
| Japan |
Condition
Condition
cerebral palsy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to research the effect of home-based training focusing on increasing the Maximum Step Length in children with cerebral palsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
walking speed, step length, cadence after 8 weeks from baseline measurement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but 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 participants are received regular physical therapy. In addition, the participants performed the home-based training (HBT) program, three times per week for 8 weeks (24 sessions) under home supervision by caregivers. The HBT is constructed only two program, loaded Sit-to-Stand and One-step trainining.
Interventions/Control_2
The participants conduct regular physical therapy only.
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
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All subjects are recruited from outpatients of Akita Prefectural Center on Development and Disability. An invitation to participate in the study is called to all families and children and adolescents who could potentially fulfill the following inclusion criteria. The inclusion criteria were: (1) age 4-19 years, (2) spastic diplegic CP, (3) gross motor function classification system (GMFCS) level I or II,(4) ability to walk independently without an orthosis for more than 10 minutes.
Key exclusion criteria
Exclusion criteria were: (1) orthopedic intervention and serial casting of the lower extremities within 6 months or (2) orthopedic problems or medical conditions that prevented children and adolescents from participating in the exercises.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Kimoto |
Organization
Akita University Graduate School
Division name
Health Sciences
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6526
kimopist@mac.com
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Kimoto |
Organization
Akita University Graduate School
Division name
Health Sciences
Zip code
010-8543
Address
1-1-1 Hondo, Akita
TEL
018-884-6526
Homepage URL
kimopist@mac.com
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita University
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
Akita University Graduate School of Medicine and Faculty of Medicine / medical ethics committee
Address
1-1-1 Hondo, Akita
Tel
018-884-6028
soken@hos.akita-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
| 2019 | Year | 04 | Month | 11 | 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
21
Results
At change score (0 to 8 w), the experimental group significantly increased from the control group in MSL (p = 0.005) and step length during the walk assessment (p = 0.021).
Results date posted
| 2019 | Year | 04 | Month | 11 | Day |
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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2019 | Year | 04 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041561
