UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Evaluation of Rehabilitation by using Child Prothesis made by the 3D Printer
Title of the study (Brief title)	Clinical Evaluation of Child Prothesis
Region	Japan

Condition
Condition	a person who needs myoelectric upper limb prosthesis training
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of a compact, lightweight, suitable sized and inexpensive hands for training myogenic hand prosthesis. A feasibility study with the developed hand in rehabilitation therapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Verification of the applicability of a child hand system made by the 3D printer, which is designed for myoelectric hand prosthesis training
Key secondary outcomes	Adverse events accompanying the installation of the device (safety confirmation and validity evaluation)

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	Use of the child's prosthesis hand which is made by the 3D printer
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	12 years-old >
Gender	Male and Female
Key inclusion criteria	A person who needs myoelectric prosthesis hand training
Key exclusion criteria	- Any patients with spasticity and solid contraction interfere with keeping sitting posture, or patient with dizziness or blood pressure drop problems during the training
Target sample size	1

Research contact person
Name of lead principal investigator	Yasushi Hada
Organization	University of Tsukuba
Division name	Faculty of Medicine
Address	2-1-1 Amakubo, Tsukuba
TEL	029-853-3219
Email	y-hada@md.tsukuba.ac.jp

Public contact
Name of contact person	Kenji Suzuki
Organization	University of Tsukuba
Division name	Center for Cybernics Research
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-5761
Homepage URL
Email	kenji@ieee.org

Sponsor
Institute	University of Tsukuba Hospital
Institute
Department

Funding Source
Organization	Center for Cybernics Research, University of Tsukuba
Organization
Division
Category of Funding Organization	Other
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	2018 Year 03 Month 09 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 03 Month 09 Day
Last modified on	2018 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036159