UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Construction of new QOL evaluation method for hemophilia using accelerometer
Title of the study (Brief title)	New QOL evaluation method for hemophilia
Region	Japan

Condition
Condition	hemophilia
Classification by specialty	Hematology and clinical oncology Pediatrics Orthopedics Rehabilitation medicine Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measure activity level, impact degree, movement speed, distance are recorded by an activity meter, an impact meter, and a wrist watch type GPS device to examine whether new QOL can be evaluated.
Basic objectives2	Others
Basic objectives -Others	To acquire data for quality-of-life instrument
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	amount of activity, degree of impact, travel distance, transfer rate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The subjects are healthy volunteers and patients visiting the pediatric department in Nara medical university, persons who can walk and can wear devices for one week.
Key exclusion criteria	People who are difficult to walk and people who can not act in daily life and those who can not fit the machines are excluded.
Target sample size	150

Research contact person
Name of lead principal investigator	Midori Shima
Organization	Nara Medical University
Division name	Department of Pediatrics
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Email	mshima@naramed-u.ac.jp

Public contact
Name of contact person	Asuka Sakata
Organization	Nara Medical University
Division name	Medicinal biology of thrombosis and hemostasis
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-23-9961
Homepage URL
Email	asusaka@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Chugai pharmaceutical co., ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	奈良県立医科大学（奈良県）

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 19 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Measure activity level, impact degree, movement speed, distance are recorded by an activity meter, an impact meter, and a wrist watch type GPS device to examine whether new QOL can be evaluated. The subjects are healthy volunteers and patients visiting the pediatric department in Nara medical university, persons who can walk and can wear devices for one week. People who are difficult to walk and people who can not act in daily life and those who can not fit the machines are excluded.

Management information
Registered date	2018 Year 11 Month 05 Day
Last modified on	2018 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039577

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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