UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017468
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tokuhiro@kibirihah.rofuku.go.jp

Sponsor
Institute Kibikogen Rehabilitation center for Employment Injuries
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020245

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.