UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062523 |
|---|---|
| Receipt number | R000071571 |
| Scientific Title | Association between AI based motion analysis indices and the onset of low back pain with participation restriction in youth baseball players: a prospective observational study |
| Date of disclosure of the study information | 2026/08/08 |
| Last modified on | 2026/08/08 15:39:44 |
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Basic information
Public title
AI based motion analysis in youth baseball players with low back pain
Acronym
AI motion analysis in youth baseball players with LBP
Scientific Title
Association between AI based motion analysis indices and the onset of low back pain with participation restriction in youth baseball players: a prospective observational study
Scientific Title:Acronym
AI motion analysis in youth baseball players with LBP
Region
| Japan |
Condition
Condition
Low back pain, Lumber spondylolysis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the association between kinematic indices obtained using AI based motion analysis during pitching and basic movement tasks and the onset of low back pain with participation restriction knowledge for developing a simple movement assessment method for future prevention of low back pain.
Basic objectives2
Others
Basic objectives -Others
This is an observational study examining the association between kinematic indices obtained using AI based motion analysis and the onset of low back pain with participation restriction.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the time to the first onset of a low back pain event with participation restriction during the follow up period.
Key secondary outcomes
Presence or absence of low back pain during the follow up period
Severity of low back pain symptoms
Duration of participation restriction due to a low back pain event with participation restriction
Type of participation restriction
Medical consultation
Diagnosis made by a doctor
Presence and intensity of injuries or pain in body regions other than the low back
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Junior high school or high school students who belongs to a community baseball team or a school baseball club.
2. Participants who have received an explanation of the study and for whom consent has been obtained from both the participant and their guardian.
3. Participants pf any sex.
Key exclusion criteria
1. Participants who have difficulty performing the movement tasks due to injury or pain in the low back pain, shoulder, elbow, lower extremity, or other body regions at the time of measurement.
2. Participants who are judged by a physician or researcher to be unsuitable for preforming the movement tasks for safety reasons.
3. Participants from whom the data required for video recording or motion analysis cannot be obtained.
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University
Division name
Professor, Department of Physical Therapy, Faculty of Health and Medical Care
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-295-1001
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University
Division name
Professor, Department of Physical Therapy, Faculty of Health and Medical Care
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-295-1001
Homepage URL
akasaka-smc@umin.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Miyoshi Kohei
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
049-276-1111
rinri@saitama-med.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
| 2026 | Year | 08 | Month | 08 | 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 | 08 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 09 | 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 prospective observational study of youth baseball players. At baseline, pitching motion, standing forward flexion, standing extension and quadruped thoracic rotation will be recorded and analyzed using smartphone-based AI motion analysis. Kinematic indices of the trunk, lumber spine, thoracic spine, and hip joint will be obtained. During the follow-up period, weekly questionnaires will be used to prospectively investigate the onset of low back pain events with participation restriction.
The primary outcome is the time to the first onset of a low back pain event with participation restriction during the follow up period.
The explanatory valuables are maximum lumber extension angle and maximum lumber rotation angle during pitching motion.
This study will examine the association between these AI-based motion analysis indices and the time to the first onset of low back disorder events with participation restriction.
Management information
Registered date
| 2026 | Year | 08 | Month | 08 | Day |
Last modified on
| 2026 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071571
