UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031379 |
|---|---|
| Receipt number | R000035258 |
| Scientific Title | Development of a new gait analysis system to support diagnoses in locomotory system diseases |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2023/03/27 10:51:18 |
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Basic information
Public title
Development of a new gait analysis system to support diagnoses in locomotory system diseases
Acronym
Gait analysis system for locomotory system diseases
Scientific Title
Development of a new gait analysis system to support diagnoses in locomotory system diseases
Scientific Title:Acronym
Gait analysis system for locomotory system diseases
Region
| Japan |
Condition
Condition
Orthopedic disorders
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of new gait analysis systems using wearable devices and gait movies to evaluate orthopaedic disease conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Mean difference of calculated gait parameters between orthopaedic disease and healthy conditions.
Key secondary outcomes
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
Orthopaedic disease patients and healthy persons who can walk safely.
Key exclusion criteria
Person whom investigators determine not appropriate for the study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kedoya |
Organization
Department of Orthopaedic Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Advanced research for functional analysis and regulation of locomotor system
Zip code
060-8638
Address
Kita-21 Nishi-11 Kita-ku, Sapporo, Japan
TEL
011-716-1161(5936)
kadoya@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kadoya |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Orthopaedic Surgery
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Japan 060-8638
TEL
011-716-1161(5936)
Homepage URL
hokudaiorthop@med.hokudai.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hitachi High-Technologies
Hokuto Social Medical 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
Institutional Review Board, Hokkaido University Hospital
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Japan 060-8638
Tel
011-701-7636
crjimu@huhp.hokudai.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
| 2018 | Year | 02 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Nothing to report
Management information
Registered date
| 2018 | Year | 02 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035258
