UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061714 |
|---|---|
| Receipt number | R000070622 |
| Scientific Title | Myoelectric hand prosthesis for congenital transverse failure |
| Date of disclosure of the study information | 2026/05/28 |
| Last modified on | 2026/05/28 07:18:32 |
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Basic information
Public title
Prosthesis for congenital transverse failure
Acronym
Prosthesis research
Scientific Title
Myoelectric hand prosthesis for congenital transverse failure
Scientific Title:Acronym
Hand prosthesis research
Region
| Japan |
Condition
Condition
Congenital transverse failure
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Congenital transverse failure causes not only cosmetic problems but also functional, postural, and skeletal impairments, including scoliosis and limitations in daily and cultural activities. Because regeneration of a normal upper limb is currently impossible, myoelectric prostheses are considered a promising means of replacing lost motor and sensory functions.
Therefore, this study aims to establish non-invasive measurement and signal-processing technologies for myoelectric prostheses controlled by surface electromyographic signals, thereby providing a technological foundation for future functional upper-limb replacement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional assessment performed every six months after myoelectric prosthesis applying (number of blocks transferred in the Box and Block Test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For patients with congenital transverse failure, individualized prostheses will be fabricated and fitted according to each case. Functional evaluations will be performed during the initial period after fitting and then every six months for approximately three years.
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
| 1 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with congenital transverse failure (including transradial and transhumeral deficiencies) who provide written informed consent for participation in this study.
Key exclusion criteria
Patients with intellectual or developmental disabilities, as well as those deemed unsuitable for participation at the discretion of the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takehiko |
| Middle name | |
| Last name | Takagi |
Organization
National Center for Child Health and Development
Division name
Division of Orthopaedic Surgery
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo
TEL
0334160181
takagi-t@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Takagi |
Organization
National Center for Child Health and Development
Division name
Division of Orthopaedic Surgery
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo
TEL
0334160181
Homepage URL
takagi-t@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
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
National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo
Tel
0334160181
takagi-t@ncchd.go.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070622
