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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025740
Receipt No. 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

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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
Email 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
Email takatoshi.sato@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029613

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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