UMIN-CTR Clinical Trial

Basic information
Public title	Examination of differences due to differences in measurement conditions in a 6-minute walking distance test using an inertial sensor (StepLab)
Acronym	Examination of differences due to differences in measurement conditions in a 6-minute walking distance test using an inertial sensor (StepLab)
Scientific Title	Examination of differences due to differences in measurement conditions in a 6-minute walking distance test using an inertial sensor (StepLab)
Scientific Title:Acronym	Examination of differences due to differences in measurement conditions in a 6-minute walking distance test using an inertial sensor (StepLab)
Region	Japan

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

Objectives
Narrative objectives1	Examination of differences due to differences in measurement conditions in the 6-minute walking distance test
Basic objectives2	Others
Basic objectives -Others	Walking analysis by inertia sensor
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	6-min walk distance
Key secondary outcomes	PCI physical cost index Borg Various walking parameters

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Walking speed
Interventions/Control_2	Walking path
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	22 years-old >=
Gender	Male
Key inclusion criteria	Healthy adult
Key exclusion criteria	Those whose measurement task may affect their physical condition. Those whose measurement task may affect their physical condition.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name isao Middle name Last name ojima
Organization	Faculty of Rehabilitation, Kobe gakuin university
Division name	department of physical therapy
Zip code	6512180
Address	518 arise, ikawadani-cho, nishi-ku Kobe, hyogo
TEL	078-974-2198
Email	ojima@reha.kobegakuin.ac.jp

Public contact
Name of contact person	1st name isao Middle name Last name ojima
Organization	Kobe gakuin university
Division name	faculty of rehabilitation
Zip code	651-2180
Address	518 arise, ikawadani-cho, nishi-ku Kobe, Hyogo
TEL	09087563844
Homepage URL
Email	ojima@reha.kobegakuin.ac.jp

Sponsor
Institute	kobe gakuin university
Institute
Department

Funding Source
Organization	kobe gakuin university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Zero C Seven, Inc
Name of secondary funder(s)

IRB Contact (For public release)
Organization	kobe gakuin university
Address	518 arise, ikawadani-cho, nishi-ku Kobe, Hyogo
Tel	0789742198
Email	ojima@reha.kobegakuin.ac.jp

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 06 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	Preinitiation
Date of protocol fixation	2022 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 12 Day
Last modified on	2022 Year 05 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054180