UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060111 |
|---|---|
| Receipt number | R000068467 |
| Scientific Title | Validation of Gait Spatiotemporal Parameters and Sagittal Joint Angles Derived from an IMU Sensor Using a 3D Motion Capture System |
| Date of disclosure of the study information | 2026/01/25 |
| Last modified on | 2025/12/18 09:24:39 |
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Basic information
Public title
Comparative Study of Gait Measurement Using an IMU Sensor and a 3D Motion Capture System
Acronym
Gait Measurement Comparison Study
Scientific Title
Validation of Gait Spatiotemporal Parameters and Sagittal Joint Angles Derived from an IMU Sensor Using a 3D Motion Capture System
Scientific Title:Acronym
GIAS: Gait IMU Analysis Study
Region
| Japan |
Condition
Condition
Healthy adults (no specific disease condition)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate gait measurements obtained from an IMU sensor by comparing spatiotemporal parameters (e.g., gait speed and stride length) and sagittal lower limb joint angles with those measured by a 3D motion capture system during walking.
Basic objectives2
Others
Basic objectives -Others
This study is a fundamental validation research that evaluates the applicability and reliability of an IMU sensor for gait measurement. It does not aim to assess clinical diagnosis or therapeutic effects. By comparing IMU-derived gait data with those from a 3D motion capture system, this study aims to clarify the use of the IMU sensor for quantitative gait analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validation of the agreement between gait spatiotemporal parameters (e.g., gait speed, stride length, gait cycle duration) and sagittal lower limb joint angles measured by an IMU sensor and those measured by a 3D motion capture system, using RMSE, ICC, and Bland-Altman analysis.
Key secondary outcomes
Evaluation of differences in sagittal lower limb joint angle waveforms throughout the gait cycle using Statistical Parametric Mapping (SPM) to identify agreement and error regions between the IMU sensor and the 3D motion capture system. In addition, exploratory analyses will be conducted to assess variations in measurement errors under different walking speeds.
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male students aged 18-25 enrolled in this university
No orthopedic or neurological disorders affecting gait
Provided written informed consent after receiving a full explanation of the study
Key exclusion criteria
Presence of orthopedic or neurological disorders, or pain that affects gait
Individuals who do not provide consent or withdraw consent during the study
Individuals judged by the investigator to be unable to safely perform gait measurements
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Soji |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Prosthetics, Orthotics and Assistive Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigatacity, Niigata, Japan
TEL
0252574579
soji-tanaka@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Soji |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation, Dept. of Prosthetics, Orthotics and Assistive Technology
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigatacity, Niigata, Japan
TEL
0252574579
Homepage URL
soji-tanaka@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Soji Tanaka
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan
Tel
025-257-4455
rinri@nuhw.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
Niigata
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an investigator-initiated clinical research study and is not intended as a clinical trial for regulatory approval of drugs or medical devices.
The study will be conducted after approval by the Ethics Committee of Niigata University of Health and Welfare and in accordance with the Declaration of Helsinki and relevant ethical guidelines.
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068467
