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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028582
Receipt No. R000032711
Scientific Title Development of the finger motion analysis device for carpal tunnel syndrome
Date of disclosure of the study information 2017/10/01
Last modified on 2017/08/25

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Basic information
Public title Development of the finger motion analysis device for carpal tunnel syndrome
Acronym Development of the finger motion analysis device
Scientific Title Development of the finger motion analysis device for carpal tunnel syndrome
Scientific Title:Acronym Development of the finger motion analysis device
Region
Japan

Condition
Condition Carpal tunnel syndrome
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 device development
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Motion analysis of thumb
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Measurement by device
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Diagnosis of carpal tunnel syndrome
Key exclusion criteria Dementia
Traffic accident
History of upper extremity injury
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Fujita
Organization Tokyo Medical and Dental University
Division name Department of Orthopedics
Zip code
Address 1-5-45 Yushima Bunkyoku Tokyo
TEL 0358035279
Email fujiorth@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Fujita
Organization Tokyo Medical and Dental University
Division name Department of Orthopedics
Zip code
Address 1-5-45 Yushima Bunkyoku Tokyo
TEL 0358035279
Homepage URL
Email fujiorth@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization YAMAHA
Organization
Division
Category of Funding Organization Profit 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 東京医科歯科大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 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 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 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
2017 Year 08 Month 08 Day
Last modified on
2017 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032711

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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