UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033889 |
|---|---|
| Receipt number | R000038655 |
| Scientific Title | Actigraph assessment for Fukuyama congenital muscular dystrophy |
| Date of disclosure of the study information | 2018/08/25 |
| Last modified on | 2022/08/27 15:43:12 |
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Basic information
Public title
Actigraph assessment for Fukuyama congenital muscular dystrophy
Acronym
Actigraph assessment for Fukuyama congenital muscular dystrophy
Scientific Title
Actigraph assessment for Fukuyama congenital muscular dystrophy
Scientific Title:Acronym
Actigraph assessment for Fukuyama congenital muscular dystrophy
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 actigraph 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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Actigraph
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with Fukuyama congenital muscular dystrophy, which is genetically diagnosed
Key exclusion criteria
Patients who cannot put actigraph
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Nagata |
Organization
Tokyo Women's Medical University
Division name
Department of Pediatrics
Zip code
1628666
Address
8-1, Kawadacho, Shinjuku-ku, Tokyo 162-8666, JAPAN
TEL
03-3353-8111
nagata.satoru@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Sato |
Organization
Tokyo Women's Medical University
Division name
Department of Pediatrics
Zip code
1628666
Address
8-1, Kawadacho, Shinjuku-ku, Tokyo 162-8666, JAPAN
TEL
03-3353-8111
Homepage URL
sato.takatoshi@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Tokyo Women's Medical University
Address
8-1, Kawadacho, Shinjuku-ku, Tokyo 162-8666, JAPAN
Tel
03-3353-8111
sato.takatoshi@twmu.ac.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
| 2018 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000038655&flwp_key=1008fnTELm2
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000038655&flwp_key=1008fnTELm2
Number of participants that the trial has enrolled
6
Results
Activity count could be well correlated with GMFM-88 score.
Results date posted
| 2022 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with Fukuyama congenital muscular dystrophy followed by Tokyo Women's Medical University
Participant flow
Patients were recruited by written consent
Adverse events
Not in particular
Outcome measures
Activity score, GMFM-88 score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 08 | Month | 24 | Day |
Last modified on
| 2022 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038655
