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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025963
Receipt No. 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 2018/02/02

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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
Middle name
Last name Toru Shibata
Organization Morinomiya Hospital
Division name Pediatric orthopedics
Zip code
Address 2-1-88, Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL 06-6969-0111
Email shibata@omichikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Okuda
Organization Morinomiya Hospital
Division name Neurorehabilitation Research Institute
Zip code
Address 2-1-88, Morinomiya, Joto-ku, Osaka-shi, Osaka, Japan
TEL 06-6969-0111
Homepage URL
Email okuda@omichikai.or.jp

Sponsor
Institute Neurorehabilitation Research Institute, Morinomiya Hospital
Institute
Department

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
Address
Tel
Email

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
2018 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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