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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035388
Receipt No. R000038499
Official scientific title of the study Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.
Date of disclosure of the study information 2019/01/04
Last modified on 2018/12/28

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Basic information
Official scientific title of the study Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.
Title of the study (Brief title) Development of the arms sprint using the elbow joint manufactured with the 3D printer for the neurologic intractable disease.
Region
Japan

Condition
Condition neurologic intractable disease
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of the arms sprint using the elbow joint manufactured with the 3D printer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Activities of daily living
Key secondary outcomes

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 Other
Interventions/Control_1 Development of the arms sprint using the elbow joint manufactured with 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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patient whose daily living behavior is restricted due to upper limb tremor and ataxia.
Key exclusion criteria Patient who can not obtain consent of this research participation.
Target sample size 3

Research contact person
Name of lead principal investigator Wakana Togami
Organization Kunmamoto University Hospital
Division name Physical Medicine and Rehabilitation
Address 1-1-1 Honjo Chuo-ku Kumamoto-city
TEL 096-373-5226
Email wakana.desu@kuh.kumamoto-u.ac.jp

Public contact
Name of contact person Wakana Togami
Organization Kunmamoto University Hospital
Division name Physical Medicine and Rehabilitation
Address 1-1-1 Honjo Chuo-ku Kumamoto-city
TEL 096-373-5226
Homepage URL
Email wakana.desu@kuh.kumamoto-u.ac.jp

Sponsor
Institute Kunmamoto University Hospital
Institute
Department

Funding Source
Organization None
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
2019 Year 01 Month 04 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 20 Day
Anticipated trial start date
2018 Year 12 Month 20 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 12 Month 28 Day
Last modified on
2018 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038499

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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