UMIN-CTR Clinical Trial

Basic information
Public title	Study on muscle activity and energy consumption due to difference in walking speed
Acronym	Study on muscle activity and energy consumption due to difference in walking speed
Scientific Title	Study on muscle activity and energy consumption due to difference in walking speed
Scientific Title:Acronym	Study on muscle activity and energy consumption due to difference in walking speed
Region	Japan

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

Objectives
Narrative objectives1	To clarify the relationship between the amount of muscle activity and energy efficiency and help to obtain useful information for the analysis of gait disturbance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Surface electromyogram
Key secondary outcomes	Physiological Cost Index : PCI

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Walking speed(very fast)
Interventions/Control_2	Walking speed(fast)
Interventions/Control_3	Walking speed(comfortable)
Interventions/Control_4	Walking speed(slow)
Interventions/Control_5	Walking speed(very slow)
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	There is consent to participate in research, there is no orthopedic and neurological disability.
Key exclusion criteria	There is Orthopedic and neurological disability.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Yumi Middle name Last name Okayama
Organization	International University of Health and Welfare
Division name	Graduate school
Zip code	250-8588
Address	1-2-25 Siroyama Odawara Kanagawa, 250-8588 Japan
TEL	0465-21-0361
Email	yumi.okayama27@gmail.com

Public contact
1st name of contact person	1st name Yumi Middle name Last name Okayama
Organization	International University of Health and Welfare
Division name	Graduate school
Zip code	250-8588
Address	1-2-25 Siroyama Odawara Kanagawa, 250-8588 Japan
TEL	0465-21-0361
Homepage URL
Email	yumi.okayama27@gmail.com

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	Osaka University of Human Sciences
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	International University of Health and Welfare
Address	1-2-25 Siroyama Odawara Kanagawa, 250-8588 Japan
Tel	0465-21-0361
Email	yumi.okayama27@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	大阪人間科学大学（大阪府）

Other administrative information
Date of disclosure of the study information	2018 Year 04 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	35
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	Completed
Date of protocol fixation	2018 Year 02 Month 08 Day
Date of IRB	2017 Year 12 Month 18 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 12 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036182