UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008665 |
|---|---|
| Receipt number | R000010186 |
| Scientific Title | Research and development of a myoelectric prosthetic hand for below-elbow amputation |
| Date of disclosure of the study information | 2012/08/10 |
| Last modified on | 2023/09/08 09:05:55 |
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Basic information
Public title
Research and development of a myoelectric prosthetic hand for below-elbow amputation
Acronym
Research and development of a myoelectric prosthetic hand for below-elbow amputation
Scientific Title
Research and development of a myoelectric prosthetic hand for below-elbow amputation
Scientific Title:Acronym
Research and development of a myoelectric prosthetic hand for below-elbow amputation
Region
| Japan |
Condition
Condition
below-elbow amputation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating a myoelectric prosthetic hand for below-elbow amputation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Generating more than eight patterns using surface electromyogram
Key secondary outcomes
Getting basis data for restructuring motion of hands and fingers
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
Using myoelectric prosthetic hand
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
below-elbow amputation
Key exclusion criteria
Congenital below-elbow amputation, patient with disability except for below-elbow amputation, patient with pacemaker, gravida, patient with mental disorder, patient with dementia, patient whom an attending physician diagnoses as inadequacy, and so on.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Mouri |
Organization
Gifu University
Division name
Faculty of Engineering
Zip code
501-1193
Address
1-1 Yanagido, Gifu
TEL
058-293-2548
mouri@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Mouri |
Organization
Gifu University
Division name
Faculty of Engineering
Zip code
501-1193
Address
1-1 Yanagido, Gifu
TEL
058-293-2548
Homepage URL
mouri@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Review Board of Gifu University of Medical Science
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
rinri@gifu-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
岐阜大学（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 10 | 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
1
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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2012 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010186
