UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The validity of spatiotemporal gait analysis using dual laser range sensors: a cross-sectional study
Title of the study (Brief title)	The validity of spatiotemporal gait analysis using dual laser range sensors: a cross-sectional study
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of present study was to investigate the validity of the proposed method using dual laser range sensors for spatiotemporal gait measurement by comparison to the reference system using a computer-based instrumented walkway system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency distributions of errors for Foot Contact and Foot Off times
Key secondary outcomes	Inter-class correlation coefficient (ICC(2,1) of six spatiotemporal gait parameters (Swing time, Stance time, Double support time, Stride time, Stride length, Step length)

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	Healthy adults
Key exclusion criteria	history of disease in orthopedic, neurophysiologic,and cardiovascular
Target sample size	10

Research contact person
Name of lead principal investigator	Masanobu Iwai
Organization	Kawamura Hospital
Division name	Department of Rehabilitation
Address	1-84 Daihannya, Akutami, Gifu, Gifu
TEL	058-241-3311
Email	masanobuiwai@gmail.com

Public contact
Name of contact person	Masanobu Iwai
Organization	Kawamura Hospital
Division name	Department of Rehabilitation
Address	1-84 Daihannya, Akutami, Gifu, Gifu
TEL	058-241-3311
Homepage URL
Email	kawamurareha@gmail.com

Sponsor
Institute	Kawamura Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fujita Health University
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	河村病院(Kawamura Hospital)，藤田保健衛生大学(Fujita Health University)

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 29 Day
Anticipated trial start date	2017 Year 08 Month 05 Day
Last follow-up date	2017 Year 10 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The detection times for Foot Contact and Foot Off estimated by the proposed method did not differ from those measured by the instrumented walkway reference system. In addition, histogram for Foot Contact and Foot Off showed monomodality. ICC(2,1) of the spatiotemporal parameters excluding swing time (0.15) were moderate (stance time: 0.74; double support time: 0.53; stride time: 0.89; stride length: 0.83; step length: 0.71). The mean errors of all spatiotemporal parameters were small.

Management information
Registered date	2018 Year 05 Month 24 Day
Last modified on	2018 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037300