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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041696
Receipt No. R000047595
Scientific Title Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/05

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Basic information
Public title Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Acronym Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Scientific Title Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Scientific Title:Acronym Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Region
Japan

Condition
Condition spinal muscular atrophy
Classification by specialty
Neurology Pediatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To construct database of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Basic objectives2 Others
Basic objectives -Others To analyze the information of database of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes General condition, respiratory status, nutritional status, changes in motor function
Key secondary outcomes changes in motor function by drug administration

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria patient diagnosed as spinal muscular atrophy
Key exclusion criteria patient who is not diagnosed as spinal muscular atrophy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Toshio
Middle name
Last name Saito
Organization National Hospital Organization Osaka Toneyama Medical Center
Division name Neurology Department
Zip code 560-8552
Address 5-1-1 Toneyama, Toyonaka, Osaka
TEL 06-6853-2001
Email saito.toshio.cq@mail.hosp.go.jp

Public contact
Name of contact person
1st name Toshio
Middle name
Last name Saito
Organization National Hospital Organization Osaka Toneyama Medical Center
Division name Neurology Department
Zip code 560-8552
Address 5-1-1 Toneyama, Toyonaka, Osaka
TEL 06-6853-2001
Homepage URL
Email saito.toshio.cq@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Osaka Toneyama Medical Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Clinical Research, National Hospital Organization Osaka Toneyama Medical Center
Address 5-1-1 Toneyama, Toyonaka, Osaka
Tel 06-6853-2001
Email 410-chiken@mail.hosp.go.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
2020 Year 09 Month 07 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
2020 Year 06 Month 20 Day
Date of IRB
2020 Year 07 Month 27 Day
Anticipated trial start date
2020 Year 09 Month 07 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research object code, birth year and month, gender,Diagnostic basis, Motor milestone, etc.
Clinical information:
Height, body weight,
motor function (ambulant, wheel chair, bed ridden,etc)
Respiratory function (voluntary, non-invasive ventilation, invasive ventilation, time of introducing, etc)
Nutritional method (per oral, tube feeding, gastrostomy tube, time of introducing,etc)
Other complication (heart failure, etc)
Medication
Evaluation of rehabilitation:
Manual muscle test:MMT, Hammersmith Functional Motor Scale-Expanded:HFMSE for SMA, revised upper limb mudule: RULM, grip power, pinch power, 2-minute walk distance, 10-meter walking evaluation, VC,CPF,MIC, etc
Clinical laboratory test:
Blood analysis, blood chemistry, atrial blood gas analysis
Chest x-ray, spine x-ray, MRI(brain, muscle, etc), CT (brain, muscle, chest, etc), echocardiography, electrocardiography, respiratory function (FVC,%FVC, etc)

Management information
Registered date
2020 Year 09 Month 05 Day
Last modified on
2020 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047595

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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