UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of myoelectric prosthetic hand fitting system
Title of the study (Brief title)	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	Tokuhiro Akihiro
Organization	Kibikogen Rehabilitation center for Employment Injuries
Division name	Dept. of orthopedic surgery
Address	7511 Yoshikawa Kibichuo-cho Kaga-gun Okayama
TEL	0866-56-7141
Email	tokuhiro@kibirihah.rofuku.go.jp

Public contact
Name of contact person	Tokuhiro Akihiro
Organization	Kibikogen Rehabilitation center for Employment Injuries
Division name	Dept. of orthopedic surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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