UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the finger motion analysis device for carpal tunnel syndrome
Title of the study (Brief title)	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	Koji Fujita
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedics
Address	1-5-45 Yushima Bunkyoku Tokyo
TEL	0358035279
Email	fujiorth@tmd.ac.jp

Public contact
Name of contact person	Koji Fujita
Organization	Tokyo Medical and Dental University
Division name	Department of Orthopedics
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 01 Day
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

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Publication of results	Unpublished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