UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025963 |
|---|---|
| Receipt number | R000029842 |
| Scientific Title | Influence of static stretch on sit to stand motion in children with spastic diplegia |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2019/09/06 16:32:20 |
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Basic information
Public title
Influence of static stretch on sit to stand motion in children with spastic diplegia
Acronym
Influence of static stretch on sit to stand motion in children with spastic diplegia
Scientific Title
Influence of static stretch on sit to stand motion in children with spastic diplegia
Scientific Title:Acronym
Influence of static stretch on sit to stand motion in children with spastic diplegia
Region
| Japan |
Condition
Condition
Cerebral palsy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective evaluation of the effect of rehabilitation for children with cerebral palsy
Basic objectives2
Others
Basic objectives -Others
evaluation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Kinematic parameter, EMG pattern and COP pattern associated with motion
Key secondary outcomes
Gross motor function measure
Gross motor function classification system
Range of motion
Modified Ashworth Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Evaluation of performance (sit to stand) before and immediately after five-minute rehabilitation (static stretch) by 3D motion analysis, electromyography and force pplate
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
| 4 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with diplegic cerebral palsy.
Patients who can sit to stand, hold upright and sit by themselves.
Key exclusion criteria
Patients whose general condition was poor to perform the task.
Patients having difficulties in understanding the study design, providing consent to, or participating in the study due to hearing or visual impairment, or intellectual disturbance.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Shibata |
Organization
Bobath Memorial Hospital
Division name
Pediatric orthopedics
Zip code
5360025
Address
2-1-88, Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL
06-6969-0111
hattori@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Misako |
| Middle name | |
| Last name | Miyata |
Organization
Morinomiya Hospital
Division name
Neurorehabilitation Research Institute
Zip code
5360025
Address
2-1-88, Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL
06-6969-0111
Homepage URL
nrri-jimu@omichikai.or.jp
Sponsor or person
Institute
Neurorehabilitation Research Institute, Morinomiya Hospital
Institute
Department
Personal name
Funding Source
Organization
Neurorehabilitation Research Institute, Morinomiya Hospital
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
Omichikai Meidical Corporation
Address
1-5-1, Higashinakahama, Joto-ku, Osaka-shi, Osaka, Japan
Tel
06-6962-9621
nrri-jimu@omichikai.or.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
| 2017 | 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
| 2016 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029842
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
