UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050013 |
|---|---|
| Receipt number | R000056966 |
| Scientific Title | Assessment of pathophysiology of haemophilia patients by pressure distribution sensor |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2023/06/08 09:16:28 |
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Basic information
Public title
Assessment of pathophysiology of haemophilia patients by pressure distribution sensor
Acronym
Assessment of pathophysiology of haemophilia patients by pressure distribution sensor
Scientific Title
Assessment of pathophysiology of haemophilia patients by pressure distribution sensor
Scientific Title:Acronym
Assessment of pathophysiology of haemophilia patients by pressure distribution sensor
Region
| Japan |
Condition
Condition
haemophilia
Classification by specialty
| Pediatrics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the performance of a treadmill-type pressure distribution sensor in detecting joint disorders and gait abnormalities in hemophiliacs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stance and gait parameters extracted from Zebris FDM-T treadmill
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
| 5 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria of PwH are the ability to ambulate independently
Key exclusion criteria
The exclusion criteria of PwH are complications of orthopaedic disease other than haemophilic arthropathy and diseases affecting movement such as neuromuscular diseases.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Shima |
Organization
Nara Medical University
Division name
Department of Pediatrics
Zip code
634-8521
Address
840 Shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
mshima@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Mawarikado |
Organization
Nara Medical University
Division name
Medicinal biology of thrombosis and hemostasis
Zip code
634-8521
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-23-9961
Homepage URL
ymawarikado@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744-23-9961
ymawarikado@naramed-u.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
| 2023 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
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
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2023 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056966
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| Registered date | File name |
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