臨床研究等提出・公開システム

Date of registration	April. 02, 2019
Last modified on	May. 10, 2021
Trial ID	jRCTs032190004

Scientific Title	A novel system for designing orthosis for muscloskeletal system (A novel system for designing orthosis for muscloskeletal system)
Public Title	A novel system for designing orthosis (A novel system for designing orthosis)

Completion date	Mar. 07, 2019
Result actual enrolment	10
Baseline Characteristics	Patients with CM arthritis of the thumb, 9 female, 1 male, mean age 57
Participant flow	Observation end on March 7, 2019. Styd completed on January 15, 2020.
Adverse events	No side effects
Outcome measures	Two different Orthosis were evaluated, short and long. 4D CT revealed the effects of two Orthoses.
Brief summary	Two different Orthosis were evaluated, short and long. 4D CT revealed the effects of two Orthoses.
Date of posting of results summaries	Jan. 15, 2020

Plan to share IPD	No
Plan description	Not applicable
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs032190004

Contact for Scientific Queries	Name	Nagura Takeo
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku, Tokyo
	Telephone	+81-3-5363-3812
	E-mail	nagura@z8.keio.jp
Contact for Public Queries	Name	Nagura Takeo
	Affiliation	Keio University School of Medicine
	Address	35 Shinanomachi, Shinjuku-ku, Tokyo
	Telephone	+81-3-5363-3812
	E-mail	nagura@z8.keio.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 17, 2018
Actual date of first enrollment		May. 17, 2018
Target sample size		200
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with hand and foot disorder , aged over 20, and healthy male or female volunteers, aged from 30 to 70, who understand the purpose of this study
	Exclusion Criteria	1. Known or possible pregnancy 2. Unable to have CT scan 3. Patients aged under 20, healthy subjects aged under 20, or over 71. 4. Subjects with abnormality, past history in hand or foot 5. Not agree to join the project
	Age Minimum	over 20
	Age Maximum	under 71
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients and healthy volunteers
Intervention(s)		Fitting of Hand Orthosis and Foot insole
Primary Outcome(s)		Morphological parameters on images
Secondary Outcome(s)		Efficacy of the brace

Source of Monetary Support / Secondary Sponsor	JSR　Corporation
Secondary Sponsor	Not applicable

Source of Monetary Support	JSR　corporation
Secondary Sponsor	Not applicable

Name of Certified Review Board	Certified Review Board of Keio
Address	35 Shinanomachi Shinjuku, Tokyo
Telephone	+81-3-5363-3503
E-Mail	med-rinri-jimu@adst.keio.ac.jp
Approval Status	Approval
Date of approval	Mar. 12, 2019

Secondary ID(s)	UMIN000030378
Issuing Authority	University hospital Medical Information Network(UMIN)

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	May. 10, 2021	(this page)	Changes
2	Jan. 28, 2020	Detail	Changes
1	April. 02, 2019	Detail

List of change history