UMIN-CTR Clinical Trial

Basic information
Public title	Verification of validity of data measured using portable motion analysis device during gait in outdoor environment
Acronym	Verification of validity of data measured using portable motion analysis device
Scientific Title	Verification of validity of data measured using portable motion analysis device during gait in outdoor environment
Scientific Title:Acronym	Verification of validity of data measured using portable motion analysis device
Region	Japan

Condition
Condition	Healthy controls
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to verify the validity of data measured using portable motion analysis device during gait in outdoor environment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	kinetic data measured using portable motion analysis device kinetic data measured using 3D motion analysis system
Key secondary outcomes	kinematic data measured using portable motion analysis device kinematic data measured using 3D motion analysis system

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Consent to participant in the study is obtained.
Key exclusion criteria	The exclusion criteria is the following.(1)neurological disorder,(2) dimentia, and (3) orthopedic diseases
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shin-Ichi Izumi
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code
Address	2-1, Seiryo-machi, Aoba-Ku, Sendai, Miyagi, Japan
TEL	022-717-7338
Email	izumis@bme.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Sekiguchi
Organization	Tohoku University Hospital
Division name	Department of Rehabilitation
Zip code
Address	1-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan
TEL	022-717-7677
Homepage URL
Email	yusuke.sekiguchi.b2@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	NEC Corporation
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

Other administrative information
Date of disclosure of the study information	2017 Year 11 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	Main results already published
Date of protocol fixation	2017 Year 10 Month 10 Day
Date of IRB	2017 Year 10 Month 16 Day
Anticipated trial start date	2017 Year 10 Month 11 Day
Last follow-up date	2018 Year 10 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Subjects walk in the following outdoor enviroments.(1)wet surface path,(2)graveled path,(3)artifitial gross,(4)stairs,and (5)slope. We examined the coincidence between data measured using portable motion analysis device and using 3D motion analsyis system.

Management information
Registered date	2017 Year 10 Month 10 Day
Last modified on	2019 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033700