UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062355 |
|---|---|
| Receipt number | R000071366 |
| Scientific Title | Validity of SPLYZA Motion for Lower Limb Biomechanical Assessment During the Forward Lunge: A Comparison with Three-Dimensional Motion Capture |
| Date of disclosure of the study information | 2026/07/27 |
| Last modified on | 2026/07/27 21:08:35 |
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Basic information
Public title
study examining whether a motion-analysis app can accurately measure leg movement during the forward lunge
Acronym
SPLYZA-Lunge Validity Study
Scientific Title
Validity of SPLYZA Motion for Lower Limb Biomechanical Assessment During the Forward Lunge: A Comparison with Three-Dimensional Motion Capture
Scientific Title:Acronym
SPLYZA-Lunge Validity Study
Region
| Japan |
Condition
Condition
Healthy volunteers (no target disease)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the validity of joint angle measurements obtained by the video-based motion analysis application SPLYZA Motion during forward lunge movement in healthy adults, by comparing hip, knee, and ankle joint angles against a laboratory-based three-dimensional motion capture system (VICON) as the reference standard.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The agreement between SPLYZA Motion and a three-dimensional motion capture system (VICON) for hip, knee, and ankle joint angles during forward lunge movement. The primary outcome measure is the intraclass correlation coefficient, ICC(2,1).
Key secondary outcomes
Mean absolute error (MAE), root mean square error (RMSE), systematic error assessed by Bland-Altman analysis (bias, 95% limits of agreement, and proportional bias), and between-trial reproducibility (ICC(3,1)).
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who can safely perform the forward lunge task and who provide informed consent
Key exclusion criteria
Individuals with a history of lower limb injury within the past six months; orthopedic disorders of the trunk or lower limbs, or a history of fracture or surgery of the hip, knee, or ankle joints; neurological or muscular diseases, peripheral neuropathy, or sensory impairment affecting daily living or sports activities; or those unable to perform the task movement.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nakanishi |
| Middle name | |
| Last name | Taku |
Organization
Kio University Graduate School
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
f6938080@kio.ac.jp
Public contact
Name of contact person
| 1st name | Nakanishi |
| Middle name | |
| Last name | Taku |
Organization
Kio University Graduate School
Division name
Graduate School of Health Sciences, Masters Program, Kio University
Zip code
635-0832,
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
f6938080@kio.ac.jp
Sponsor or person
Institute
Kio univercity
Institute
Department
Personal name
NakanishiTaku
Funding Source
Organization
Kio univercity
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
Graduate School, Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
f6938080@kio.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
畿央大学校内
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 27 | 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
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional observational study to validate the video-based motion analysis application SPLYZA Motion against a three-dimensional motion capture system for measuring lower limb joint angles during forward lunge movement. Healthy adults are assessed, and the agreement of hip, knee, and ankle joint angles measured simultaneously by both systems is evaluated using intraclass correlation coefficients and Bland-Altman analysis.
Management information
Registered date
| 2026 | Year | 07 | Month | 27 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071366
