UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056775 |
|---|---|
| Receipt number | R000064572 |
| Scientific Title | Prevention of anterior cruciate ligament injuries through virtual reality-based motor learning transfer. |
| Date of disclosure of the study information | 2025/02/08 |
| Last modified on | 2025/01/21 23:07:33 |
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Basic information
Public title
Prevention of anterior cruciate ligament injuries through virtual reality-based motor learning transfer.
Acronym
Prevention of anterior cruciate ligament injuries through virtual reality-based motor learning transfer.
Scientific Title
Prevention of anterior cruciate ligament injuries through virtual reality-based motor learning transfer.
Scientific Title:Acronym
Prevention of anterior cruciate ligament injuries through virtual reality-based motor learning transfer.
Region
| Japan |
Condition
Condition
anterior cruciate ligament injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether VR-based prevention training for anterior cruciate ligament injuries is capable of motor learning transfer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the lateral flexion angle of the trunk and the abduction moment of the knee joint.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform the 90 degree cutting task in a realistic environment. First, the participants are asked to run forward at 80% speed (to prevent the task from causing ACL injury) and then perform the task of cutting 90 degree to the right if the number is even or to the left if the number is odd, in relation to the number shown in the middle of the task. The numbers shown at this time are random. Perform this task 20 times.
Interventions/Control_2
The 90 degree cutting task is performed in a virtual reality environment. At the start of the training, the opponent starts to move forward to receive the ball and the participant follows him so that they do not move apart. The opponent then changes direction suddenly and randomly to the left and right, and the examinee performs cutting accordingly. The task is completed after the end of the cutting. This task is performed 20 times.
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
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
University students who are members of the American football team at Kyoto University, aged 18 or over, and who have not suffered any serious injuries such as broken bones or ligament injuries in the past six months.
Key exclusion criteria
Those that do not meet the above selection criteria.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Aoyama |
Organization
Kyoto University, Graduate School of Medicine, Department of Human Health Sciences
Division name
Course in Advanced Rehabilitation Science, Department of Advanced Physical Therapy
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3952
aoyama.tomoki.4e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Takahara |
Organization
Kyoto University, Graduate School of Medicine, Department of Human Health Sciences
Division name
Course in Advanced Rehabilitation Science, Department of Advanced Physical Therapy
Zip code
606-8357
Address
201, Shogoin Taniguchi Mansion Annex, 4-33 Rengezo-cho, Shogoin, Sakyo-ku, Kyoto-shi, Kyoto
TEL
08026900595
Homepage URL
takahara.wataru.85n@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Graduate School of Medicine, Department of Human Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2025 | Year | 02 | 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
| 2024 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064572
