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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030295
Receipt No. R000034598
Scientific Title A study about the improvement in effect of movement by walking assist instruments (part 1)
Date of disclosure of the study information 2017/12/12
Last modified on 2019/12/12

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Basic information
Public title A study about the improvement in effect of movement by walking assist instruments (part 1)
Acronym A study about the improvement in effect of movement by walking assist instruments (part 1)
Scientific Title A study about the improvement in effect of movement by walking assist instruments (part 1)
Scientific Title:Acronym A study about the improvement in effect of movement by walking assist instruments (part 1)
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect on gait by the presence or absence of walking assist instruments.
Basic objectives2 Others
Basic objectives -Others Comparison of walking movement with/without walking assist instruments
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation the presence or absence of walking assist instruments by kinematics and kinetics using three-dimensional motion analysis .
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 A gait for 15 minutes -> A gait by using walking assist instruments for 15 minutes -> A gait for 15 minutes
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
69 years-old >=
Gender Male and Female
Key inclusion criteria Experts of gait by using walking assist instruments.
Key exclusion criteria -Subjects with difficult for walking.
-Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Motoki
Middle name
Last name Sudo
Organization Kao Corporation
Division name R&D -Development Research- Personal Health Care Research Health Care Solutions.
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-3-5630-7486
Email sudo.motoki@kao.com

Public contact
Name of contact person
1st name Tomoya
Middle name
Last name Ueda
Organization Kao Corporation
Division name R&D -Development Research- Personal Health Care Research Health Care Solutions
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-3-5630-7486
Homepage URL
Email ueda.tomoya@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao 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 Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-9220
Email uesaka.toshio@kao.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 花王株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 12 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 15
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
2017 Year 11 Month 29 Day
Date of IRB
2017 Year 11 Month 29 Day
Anticipated trial start date
2017 Year 12 Month 13 Day
Last follow-up date
2019 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 07 Day
Last modified on
2019 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034598

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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