UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017468 |
|---|---|
| Receipt number | R000020245 |
| Scientific Title | Development of myoelectric prosthetic hand fitting system |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2017/05/31 15:16:54 |
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Basic information
Public title
Development of myoelectric prosthetic hand fitting system
Acronym
myoelectric prosthetic hand fitting
Scientific Title
Development of myoelectric prosthetic hand fitting system
Scientific Title:Acronym
myoelectric prosthetic hand fitting
Region
| Japan |
Condition
Condition
trans-radial amputation
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
promotion of the myoelectric prosthetic hand
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
increase of myoelectric prosthetic hand prescribed case
Key secondary outcomes
effectiveness of the fitting manual
Base
Study type
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 | Maneuver |
Interventions/Control_1
3 years planning. 1st year : collect the data of upper extremity amputees. 2nd year : edit the provisional fitting manual, and fitting in actual case. 3rd year : verify the utility of the fitting manual.
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
trans-radial amputee due to work-related injury
Key exclusion criteria
trans-radial amputee without injury
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokuhiro Akihiro |
Organization
Kibikogen Rehabilitation center for Employment Injuries
Division name
Dept. of orthopedic surgery
Zip code
Address
7511 Yoshikawa Kibichuo-cho Kaga-gun Okayama
TEL
0866-56-7141
tokuhiro@kibirihah.rofuku.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokuhiro Akihiro |
Organization
Kibikogen Rehabilitation center for Employment Injuries
Division name
Dept. of orthopedic surgery
Zip code
Address
7511 Yoshikawa Kibichuo-cho Kaga-gun Okayama
TEL
0866-56-7141
Homepage URL
tokuhiro@kibirihah.rofuku.go.jp
Sponsor or person
Institute
Kibikogen Rehabilitation center for Employment Injuries
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 11 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020245
