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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034439
Receipt No. R000039269
Scientific Title Gait analysis using "Gait Judge System"; Reliability and factors affecting the measurement.
Date of disclosure of the study information 2018/10/10
Last modified on 2019/06/21

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Basic information
Public title Gait analysis using "Gait Judge System"; Reliability and factors affecting the measurement.
Acronym Reliability and factors affecting the measurement on Gait Judge System.
Scientific Title Gait analysis using "Gait Judge System"; Reliability and factors affecting the measurement.
Scientific Title:Acronym Reliability and factors affecting the measurement on Gait Judge System.
Region
Japan

Condition
Condition Cerebrovascular Diseases
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the reliability and factors affecting the measurement with varied conditions on "Gait Judge System".
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intra-rater reliability, inter-rater reliability, change in measurement values with varied conditions (gait speed, angle of the foot joint, and heel up)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Assessment of plantarflexion moment of the ankle joint by "Gait Judge System".
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteers
Key exclusion criteria Unsuited condition for investigation such as gait disorder
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikio Fujimoto
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Rehabilitation
Zip code
Address 1981 Kamoda Kawagoe Japan
TEL 049-228-3400
Email m_fujimo@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikio Fujimoto
Organization Saitama Medical Center, Saitama Medical university
Division name Department of Rehabilitation
Zip code
Address 1981 Kamoda Kawagoe Japan
TEL 049-228-3400
Homepage URL
Email m_fujimo@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization the Research Foundation for Rehabilitation Medicine
Organization
Division
Category of Funding Organization Non profit foundation
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 10 Month 10 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 30
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
2018 Year 10 Month 10 Day
Date of IRB
2018 Year 11 Month 12 Day
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
2020 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
2018 Year 10 Month 10 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039269

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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