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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000034767 |
Receipt No. | R000039577 |
Official scientific title of the study | Construction of new QOL evaluation method for hemophilia using accelerometer |
Date of disclosure of the study information | 2018/12/01 |
Last modified on | 2018/10/31 |
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 |
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Condition | |||||||
Condition | hemophilia | ||||||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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 | |
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 |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
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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 |
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Last modified on |
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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 |