UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028882 |
|---|---|
| Receipt number | R000033055 |
| Scientific Title | Modified gross motor function measure for Fukuyama congenital muscular dystrophy |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2017/08/29 14:54:45 |
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Basic information
Public title
Modified gross motor function measure for Fukuyama congenital muscular dystrophy
Acronym
Modified GMFM for FCMD
Scientific Title
Modified gross motor function measure for Fukuyama congenital muscular dystrophy
Scientific Title:Acronym
Modified GMFM for FCMD
Region
| Japan |
Condition
Condition
Fukuyama congenital muscular dystrophy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess a validity of modified gross motor function measure for Fukuyama congenital muscular dystrophy
Basic objectives2
Others
Basic objectives -Others
Quantitative measure for motor function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inter-rater validity
Key secondary outcomes
Difference of assessment time between by modified GMFM and by GMFM-88
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Physical therapists will assess at least once the patients by modified GMFM or GMFM-88
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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients examined at Tokyo Women's Medical University
Key exclusion criteria
Patients who receive NPPV or TIV
Patients who were thought as inappropriate by us
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi NAGATA |
Organization
Tokyo Women's Medical University
Division name
Department of Pediatrics
Zip code
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo 162-8666
TEL
03-3353-8111
takatoshi.sato@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatoshi SATO |
Organization
Tokyo Women's Medical University
Division name
Department of Pediatrics
Zip code
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo 162-8666
TEL
03-3353-8111
Homepage URL
takatoshi.sato@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical 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
Address
Tel
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 | 09 | 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
| 2017 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | 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
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2017 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033055
