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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031379
Receipt No. 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 2018/02/20

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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
Middle name
Last name Ken Kadoya
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
Address Kita-21 Nishi-11 Kita-ku, Sapporo, Japan 001-0021
TEL 011-716-1161(5936)
Email kadoya@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Kadoya
Organization Graduate School of Medicine, Hokkaido University
Division name Department of Orthopaedic Surgery
Zip code
Address Kita-15 Nishi-7, Kita-ku, Sapporo, Japan 060-8638
TEL 011-716-1161(5936)
Homepage URL
Email hokudaiorthop@med.hokudai.ac.jp

Sponsor
Institute Graduate School of Medicine, Hokkaido University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 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
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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