UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039712 |
|---|---|
| Receipt number | R000045294 |
| Scientific Title | Change in gait and perception of walking due to guidance of pole working for adults |
| Date of disclosure of the study information | 2020/03/05 |
| Last modified on | 2022/03/17 16:53:38 |
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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
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
shota.kagawa@tohto.ac.jp
Sponsor or person
Institute
Tohto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045294
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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