UMIN-CTR Clinical Trial

Basic information
Public title	Change in gait and perception of walking due to guidance of pole working for adults
Acronym	effect of PW guidance
Scientific Title	Change in gait and perception of walking due to guidance of pole working for adults
Scientific Title:Acronym	effect of PW guidance
Region	Japan

Condition
Condition	Lifestyle-related diseases
Classification by specialty	Medicine in general Orthopedics Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify how the gait and perception of walking of healthy adults changes under the guidance of Paul Walking.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	walking speed pace root mean square step symmetry stride regularity harmonic ratio
Key secondary outcomes	the first step grounding time the first step grounding distance

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	lecture and practical guidance on Paul Walking for about 2 hours once
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	18 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy adults
Key exclusion criteria	serious illness currently going to hospital / medical treatment
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shota Middle name Last name Kagawa
Organization	Tohto University
Division name	Faculty of Human Care at Makuhari
Zip code	261-0021
Address	1-1, Hibino, Mihama-ward, Chiba-city, Chiba-prefecture
TEL	043-273-1111
Email	shota.kagawa@tohto.ac.jp

Public contact
Name of contact person	1st name Shota Middle name Last name Kagawa
Organization	Tohto University
Division name	Faculty of Human Care at Makuhari
Zip code	261-0021
Address	1-1, Hibino, Mihama-ward, Chiba-city, Chiba-prefecture
TEL	043-273-1111
Homepage URL
Email	shota.kagawa@tohto.ac.jp

Sponsor
Institute	Tohto University
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohto University
Address	4-2-11, Kamishiba-cho-nishi, Fukaya-city, Saitama-prefecture
Tel	048-574-2500
Email	meng.zhao@tohto.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	2020 Year 03 Month 05 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	Terminated
Date of protocol fixation	2019 Year 08 Month 31 Day
Date of IRB	2019 Year 08 Month 31 Day
Anticipated trial start date	2020 Year 02 Month 13 Day
Last follow-up date	2020 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	2020 Year 03 Month 05 Day
Last modified on	2022 Year 03 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045294