UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029500 |
|---|---|
| Receipt number | R000033700 |
| Scientific Title | Verification of validity of data measured using portable motion analysis device during gait in outdoor environment |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/10/25 20:37:11 |
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Basic information
Public title
Verification of validity of data measured using portable motion analysis device during gait in outdoor environment
Acronym
Verification of validity of data measured using portable motion analysis device
Scientific Title
Verification of validity of data measured using portable motion analysis device during gait in outdoor environment
Scientific Title:Acronym
Verification of validity of data measured using portable motion analysis device
Region
| Japan |
Condition
Condition
Healthy controls
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to verify the validity of data measured using portable motion analysis device during gait in outdoor environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
kinetic data measured using portable motion analysis device
kinetic data measured using 3D motion analysis system
Key secondary outcomes
kinematic data measured using portable motion analysis device
kinematic data measured using 3D motion analysis system
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consent to participant in the study is obtained.
Key exclusion criteria
The exclusion criteria is the following.(1)neurological disorder,(2) dimentia, and (3) orthopedic diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-Ichi Izumi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
Address
2-1, Seiryo-machi, Aoba-Ku, Sendai, Miyagi, Japan
TEL
022-717-7338
izumis@bme.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Sekiguchi |
Organization
Tohoku University Hospital
Division name
Department of Rehabilitation
Zip code
Address
1-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan
TEL
022-717-7677
Homepage URL
yusuke.sekiguchi.b2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
NEC 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
Address
Tel
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
| 2017 | Year | 11 | 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
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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects walk in the following outdoor enviroments.(1)wet surface path,(2)graveled path,(3)artifitial gross,(4)stairs,and (5)slope. We examined the coincidence between data measured using portable motion analysis device and using 3D motion analsyis system.
Management information
Registered date
| 2017 | Year | 10 | Month | 10 | Day |
Last modified on
| 2019 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033700
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
