UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025740 |
|---|---|
| Receipt number | R000029613 |
| Scientific Title | Actigraph monitoring for Fukuyama congenital muscular dystrophy |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/01/19 11:00:45 |
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Basic information
Public title
Actigraph monitoring for Fukuyama congenital muscular dystrophy
Acronym
Actigraph monitoring for Fukuyama congenital muscular dystrophy
Scientific Title
Actigraph monitoring for Fukuyama congenital muscular dystrophy
Scientific Title:Acronym
Actigraph monitoring for Fukuyama congenital muscular dystrophy
Region
| Japan |
Condition
Condition
Fukuyama congenital muscular dystrophy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess a validity for actigraph monitoring as a motor functional scale for Fukuyama congenital muscular dystrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between actigraph and gross motor function measure
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
We will assess actigraph monitoring every 6 month for 3 years for all recruited FCMD patients. Two types of actigraph will be tried for 3 days respectively in one assessment.
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
The patients who consent to our study recruitment.
Key exclusion criteria
The patients who cannot patient for this study.
The patients who are thought inappropriate by us.
Target sample size
15
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 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | 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 | 01 | Month | 19 | Day |
Last modified on
| 2017 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029613
