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

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 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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name