UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046815 |
|---|---|
| Receipt number | R000053393 |
| Scientific Title | Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health |
| Date of disclosure of the study information | 2022/03/08 |
| Last modified on | 2022/03/08 21:49:39 |
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Basic information
Public title
Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health
Acronym
Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health
Scientific Title
Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health
Scientific Title:Acronym
Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health
Region
| Japan |
Condition
Condition
LCS
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is aimed for the construction of the rating system of the claudicatio intermittens which is objective, and is scientific and exact based on the actual value with the wearable sensor.
Basic objectives2
Others
Basic objectives -Others
Effect measurement of the surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Locomotor observation data (video, accelerometer, statistical analysis, and the like)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who accept claudicatio intermittens because of lumbar spinal canal stenosis
Key exclusion criteria
Independence difficulty in walking person
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Musha |
Organization
Toho university
Division name
Orthopedics
Zip code
153-8515
Address
ohashi meguro tokyo 2-22-36
TEL
03-3468-1251
toho-yishimi@gmail.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Ishimine |
Organization
Toho university
Division name
Orthopedics
Zip code
153-8515
Address
ohashi meguro tokyo 2-22-36
TEL
03-3468-1251
Homepage URL
toho-yishimi@gmail.com
Sponsor or person
Institute
Toho universyty
Institute
Department
Personal name
Funding Source
Organization
none
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
Toho universyty
Address
ohashi meguro tokyo 2-22-36
Tel
03-3468-1251
toho-yishimi@gmail.com
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
| 2022 | Year | 03 | Month | 08 | 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
19
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053393
