UMIN-CTR Clinical Trial

Basic information
Public title	Estimation of gait independence using an inertial sensor
Acronym	Estimation of gait independence
Scientific Title	Estimation of gait independence using an inertial sensor
Scientific Title:Acronym	Estimation of gait independence
Region	Japan Europe

Condition
Condition	Stroke, Respiratory disease, Neuromuscular disease, Cardiovascular disease
Classification by specialty	Cardiology Pneumology Neurology Vascular surgery Chest surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify whether a gait analysis using an accelerometer could estimate gait independence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Trunk acceleration during walking
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	the ability to walk 10 m with or without assistance
Key exclusion criteria	with cognitive disfunction
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Osaka
Organization	Kawasaki University of Medical Welfare
Division name	Department of Physical Therapy
Zip code	7010193
Address	288, Matsushima, Kurashiki, Okayama, Japan
TEL	0864621111
Email	osaka@mw.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Osaka
Organization	Kawasaki University of Medical Welfare
Division name	Department of Physical Therapy
Zip code	7010193
Address	288, Matsushima, Kurashiki, Okayama, Japan
TEL	0864621111
Homepage URL
Email	osaka@mw.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki University of Medical Welfare
Institute
Department

Funding Source
Organization	Kawasaki University of Medical Welfare
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	Kawasaki University of Medical Welfare
Address	288, Matsushima, Kurashiki, Okayama, Japan
Tel	0864621111
Email	osaka@mw.kawasaki-m.ac.lp

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	2018 Year 11 Month 11 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	Open public recruiting
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 12 Month 28 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Gait analysis, grip, muscle strength(Knee extension), Timed up and go test, FIM

Management information
Registered date	2018 Year 11 Month 09 Day
Last modified on	2021 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039721