UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042456 |
|---|---|
| Receipt number | R000048465 |
| Scientific Title | Effect of tilting condition on the outside of one side of the lower leg in a healthy person on the astringent process of steady walking from the beginning of walking |
| Date of disclosure of the study information | 2020/11/15 |
| Last modified on | 2020/11/15 11:29:12 |
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Basic information
Public title
Effect of tilting condition on the outside of one side of the lower leg in a healthy person on the astringent process of steady walking from the beginning of walking
Acronym
Effect of tilting condition on the outside of one side of the lower leg in a healthy person on the astringent process of steady walking from the beginning of walking
Scientific Title
Effect of tilting condition on the outside of one side of the lower leg in a healthy person on the astringent process of steady walking from the beginning of walking
Scientific Title:Acronym
Effect of tilting condition on the outside of one side of the lower leg in a healthy person on the astringent process of steady walking from the beginning of walking
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to compare walking and normal walking when the condition of lateral inclination of the lower leg on one side is changed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluation of kinematics and kinematic mechanics numerical indicators, and ease of walking in the process of walking 8 m from the start of walking
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Walking by changing the lateral inclination of the lower leg on one side. 1 time 8 sec. Period 1 day.
Interventions/Control_2
Walking without changing the lateral inclination of the lower leg on one side. 1 time 8 sec. Period 1 day.
Interventions/Control_3
Natural walking. 1 time 8 sec. Period 1 day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Cognitive disorders
Movement disorders
Sensory disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Miyasaka |
Organization
Hokkaido University of Science
Division name
Graduate School of Health Sciences The Division of Rehabilitation Sciences Master's course
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
TEL
011-688-2232
tmiyasaka-hus@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Miyasaka |
Organization
Hokkaido University of Science
Division name
Graduate School of Health Sciences The Division of Rehabilitation Sciences Master's course
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
TEL
011-688-2232
Homepage URL
tmiyasaka-hus@umin.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Health Sciences The Division of Rehabilitation Sciences Master's course
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
Hokkaido University of Science
Address
7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
Tel
011-688-2232
tmiyasaka-hus@umin.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
北海道科学大学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 15 | 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
| 2020 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2022 | 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 | 11 | Month | 15 | Day |
Last modified on
| 2020 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048465
