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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031660
Receipt No. R000036159
Scientific Title Clinical Evaluation of Rehabilitation by using Child Prothesis made by the 3D Printer
Date of disclosure of the study information 2018/03/09
Last modified on 2018/03/09

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Basic information
Public title Clinical Evaluation of Rehabilitation by using Child Prothesis made by the 3D Printer
Acronym Clinical Evaluation of Child Prothesis
Scientific Title Clinical Evaluation of Rehabilitation by using Child Prothesis made by the 3D Printer
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasushi Hada
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 2-1-1 Amakubo, Tsukuba
TEL 029-853-3219
Email y-hada@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Suzuki
Organization University of Tsukuba
Division name Center for Cybernics Research
Zip code
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)

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
2018 Year 03 Month 09 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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