UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054764 |
|---|---|
| Receipt number | R000062577 |
| Scientific Title | Development and clinical application of a quantitative real-time simple gait analysis system |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2025/09/14 16:23:52 |
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Basic information
Public title
Development and clinical application of a quantitative real-time simple gait analysis system
Acronym
Development and application of a simple gait analysis system
Scientific Title
Development and clinical application of a quantitative real-time simple gait analysis system
Scientific Title:Acronym
Development and application of a simple gait analysis system
Region
| Japan |
Condition
Condition
healthy subject
cerebrovascular disease, musculoskeletal disease, etc.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To devise a more clinically oriented gait analysis method by developing and verifying the reliability of a new gait analysis method, as well as generating grand average data from healthy subjects' data and examining its clinical application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic indices (time and distance factors, toe clearance and its breakdown) during gait obtained by instrument measurement will be the primary endpoints.
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
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Healthy subjects and patients will be asked to walk on a treadmill and the values will be measured simultaneously by a commercially available gait analysis device and a gait analysis device under development.
Duration of intervention: 1 day
Number of interventions: 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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subjects
Persons who have obtained written consent to participate in this study from the individual or a substitute consenter
Persons who are between 10 and 80 years old at the time of consent. 3.
Able to walk on a treadmill without using a handrail.
Patients
Persons who have obtained written consent to participate in this study from the patient or a surrogate.
Persons who are at least 20 years old and less than 85 years old at the time of obtaining consent.
Able to walk on a treadmill (use of handrails or orthotics is permitted)
Able to understand the tasks and follow the instructions.
Key exclusion criteria
Persons with diseases of the central nervous system or motor organs (healthy persons)
Pregnant women and those who may become pregnant
Patients requiring isolation due to infectious diseases
Other persons who are deemed inappropriate by the principal investigator or principal research scientist.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
yootaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
yootaka@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2024 | Year | 06 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
November 22, 2022: Version 2 Created; Implementation Permitted December 21, 2022
July 22, 2023: Version 3 Created; Implementation Permitted September 5, 2023
July 9, 2025: Version 4 Created; Implementation Permitted July 31, 2025
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062577
