UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032710 |
|---|---|
| Receipt number | R000037300 |
| Scientific Title | The validity of spatiotemporal gait analysis using dual laser range sensors: a cross-sectional study |
| Date of disclosure of the study information | 2018/05/24 |
| Last modified on | 2018/05/24 19:22:33 |
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Basic information
Public title
The validity of spatiotemporal gait analysis using dual laser range sensors: a cross-sectional study
Acronym
The validity of spatiotemporal gait analysis using dual laser range sensors: a cross-sectional study
Scientific Title
The validity of spatiotemporal gait analysis using dual laser range sensors: a cross-sectional study
Scientific Title:Acronym
The validity of spatiotemporal gait analysis using dual laser range sensors: a cross-sectional study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of present study was to investigate the validity of the proposed method using dual laser range sensors for spatiotemporal gait measurement by comparison to the reference system using a computer-based instrumented walkway system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency distributions of errors for Foot Contact and Foot Off times
Key secondary outcomes
Inter-class correlation coefficient (ICC(2,1) of six spatiotemporal gait parameters (Swing time, Stance time, Double support time, Stride time, Stride length, Step length)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
history of disease in orthopedic, neurophysiologic,and cardiovascular
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanobu Iwai |
Organization
Kawamura Hospital
Division name
Department of Rehabilitation
Zip code
Address
1-84 Daihannya, Akutami, Gifu, Gifu
TEL
058-241-3311
masanobuiwai@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanobu Iwai |
Organization
Kawamura Hospital
Division name
Department of Rehabilitation
Zip code
Address
1-84 Daihannya, Akutami, Gifu, Gifu
TEL
058-241-3311
Homepage URL
kawamurareha@gmail.com
Sponsor or person
Institute
Kawamura Hospital
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
Fujita Health University
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
河村病院(Kawamura Hospital)，藤田保健衛生大学(Fujita Health University)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 24 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 12 | Month | 21 | Day |
Other
Other related information
The detection times for Foot Contact and Foot Off estimated by the proposed method did not differ from those measured by the instrumented walkway reference system. In addition, histogram for Foot Contact and Foot Off showed monomodality.
ICC(2,1) of the spatiotemporal parameters excluding swing time (0.15) were moderate (stance time: 0.74; double support time: 0.53; stride time: 0.89; stride length: 0.83; step length: 0.71). The mean errors of all spatiotemporal parameters were small.
Management information
Registered date
| 2018 | Year | 05 | Month | 24 | Day |
Last modified on
| 2018 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037300
| 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 |
