UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056084 |
|---|---|
| Receipt number | R000064084 |
| Scientific Title | Research into the ideal system for providing prosthetic devices with technological innovation in mind: Comparison of plaster bandages and 3D scanning |
| Date of disclosure of the study information | 2024/11/07 |
| Last modified on | 2024/11/07 10:50:52 |
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Basic information
Public title
Research into the ideal system for providing prosthetic devices with technological innovation in mind: Comparison of plaster bandages and 3D scanning
Acronym
Research into the state of 3D technology in the prosthetic device subsidy system
Scientific Title
Research into the ideal system for providing prosthetic devices with technological innovation in mind: Comparison of plaster bandages and 3D scanning
Scientific Title:Acronym
Research into the ideal system for providing prosthetic devices with technological innovation in mind: Comparison of plaster bandages and 3D scanning
Region
| Japan |
Condition
Condition
Spinal disorders
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, 3D technology has been widely introduced in the field of prosthetics and orthotics, and has attracted a lot of attention within the industry. The reasons for this include "shortening the time required for taking molds and production," "no need to restore the original state by wiping or cleaning because plaster is not used," and "easy data accumulation," and there are an increasing number of companies that use 3D scanners to capture body shapes. However, there are few research reports both in Japan and overseas on whether the same reproducibility is guaranteed as with conventional plaster molds, and whether the same compatibility is obtained in terms of body compatibility, which is the most important, and there is no established evidence. Furthermore, there is an issue that the compatibility of the maker's technical ability and experience level can affect the production of prosthetics and orthotics.
Therefore, in this study, a mold is taken using plaster bandages, and the plaster negative model is 3D scanned with an insert camera and modeled into 3D CAD. On the other hand, the same part is scanned using a 3D scanner, and the shape of the 3D data of the plaster model is compared with the 3D data of the 3D scanner. Based on the obtained 3D data, the aim is to create trunk orthoses manufactured using conventional and 3D methods and evaluate and analyze their compatibility. By creating an evaluation sheet using a rubric for reproducibility and physical compatibility, which have not been clarified until now, and by scoring it, it will be possible to analyze the specific evaluations using the two methods, conventional and 3D, and clarify the usefulness of 3D technology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subjects were model subjects, and 10 experienced prosthetists were tasked with creating and fitting a trunk orthosis made using the conventional method of casting a plaster cast, as well as a trunk orthosis made using a 3D scan.
Analysis items included work time, cost, a questionnaire survey of the subjects, and a compatibility evaluation based on a rubric table.
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants must be healthy adults with no history of orthopedic or spinal disease.
Key exclusion criteria
People with a history of orthopedic or spinal disease, such as lower back pain.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | hironori |
| Middle name | |
| Last name | suda |
Organization
Niigata University of Health and Welfar
Division name
Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-City
TEL
025-257-4602
suda@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | hironori |
| Middle name | |
| Last name | suda |
Organization
Niigata University of Health and Welfare
Division name
Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
3198
Address
Niigata University of Health and Welfare
TEL
0252574602
Homepage URL
suda@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
hironori suda
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-City
Tel
0252574602
suda@nuhw.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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 07 | 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
| 2024 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064084
