UMIN-CTR Clinical Trial

Basic information
Public title	Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health
Acronym	Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health
Scientific Title	Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health
Scientific Title:Acronym	Diagnosis of the orthopedics region disease by patient-generated health data using the mobile health
Region	Japan

Condition
Condition	LCS
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is aimed for the construction of the rating system of the claudicatio intermittens which is objective, and is scientific and exact based on the actual value with the wearable sensor.
Basic objectives2	Others
Basic objectives -Others	Effect measurement of the surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Locomotor observation data (video, accelerometer, statistical analysis, and the like)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who accept claudicatio intermittens because of lumbar spinal canal stenosis
Key exclusion criteria	Independence difficulty in walking person
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoshiro Middle name Last name Musha
Organization	Toho university
Division name	Orthopedics
Zip code	153-8515
Address	ohashi meguro tokyo 2-22-36
TEL	03-3468-1251
Email	toho-yishimi@gmail.com

Public contact
Name of contact person	1st name Yohei Middle name Last name Ishimine
Organization	Toho university
Division name	Orthopedics
Zip code	153-8515
Address	ohashi meguro tokyo 2-22-36
TEL	03-3468-1251
Homepage URL
Email	toho-yishimi@gmail.com

Sponsor
Institute	Toho universyty
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)

IRB Contact (For public release)
Organization	Toho universyty
Address	ohashi meguro tokyo 2-22-36
Tel	03-3468-1251
Email	toho-yishimi@gmail.com

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	2022 Year 03 Month 08 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	19
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	No longer recruiting
Date of protocol fixation	2019 Year 01 Month 01 Day
Date of IRB	2019 Year 01 Month 23 Day
Anticipated trial start date	2022 Year 01 Month 01 Day
Last follow-up date	2023 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 02 Month 03 Day
Last modified on	2022 Year 03 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053393