UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053062 |
|---|---|
| Receipt number | R000060548 |
| Scientific Title | Reliability and validity of limb volume measurements using a 3D handheld scanner |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2023/12/11 18:32:47 |
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Basic information
Public title
Accuracy of arm volume measurements with 3D handheld scanners
Acronym
Measurement accuracy of 3D handheld scanners
Scientific Title
Reliability and validity of limb volume measurements using a 3D handheld scanner
Scientific Title:Acronym
Accuracy of limb volume measurements using a 3D handheld scanner
Region
| Japan |
Condition
Condition
Healthy young subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the inter-tater reliability, concurrent validity, and presence of systematic errors in limb volume measurements using a 3D handheld scanner.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cross-sectional differences in volumes of the hand (2 cm above the sternum to distal end of upper limb), forearm (elbow fossa to distal end of upper limb) and upper arm (2 cm below axilla to distal end of upper limb) using the 3D handheld scanner and water displacement method.
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
(1) Students currently enrolled in the Faculty of Health Sciences of Saitama Medical University (regardless of gender)
(2) Those who wish to participate in the research
Key exclusion criteria
Persons with skin diseases, trauma or deformities of the upper limb.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Natsuki |
| Middle name | |
| Last name | Shimizu |
Organization
Saitama Medical University
Division name
Facluty of Health and Care
Zip code
3500496
Address
981, Kawakado, Moroyama-town, Saitama prefecture
TEL
+81-49-295-1001
natsuki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Shimizu |
Organization
Saitama Medical University
Division name
Facluty of Health and Care
Zip code
3500496
Address
981, Kawakado, Moroyama-town, Saitama prefecture
TEL
+81-49-295-1001
Homepage URL
natsuki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama 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
Ethical Committee of Saitama Medical University
Address
38, Moro Hongo, Moroyama-cho, Iruma-gun, Saitama, Japan
Tel
+81-49-276-2143
rinri@saitama-med.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 | 12 | Month | 20 | 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
| 2023 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure the upper limb volume of the subject by means of the 3D Handy Scanner and the water displacement method. Validate the measurements of the 3D Handy Scanner using the volume measurements from the water displacement method as a reference. Check for allergies to the skin markers used to mark the measurement in advance.
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060548
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
