UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040356 |
|---|---|
| Receipt number | R000046054 |
| Scientific Title | Knee wobbling phenomenon to predict ACL injury risk in young female basketball athletes. |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2024/11/19 09:49:39 |
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Basic information
Public title
Knee wobbling phenomenon to predict ACL injury risk in young female basketball athletes.
Acronym
Knee wobbling to predict ACL injury
Scientific Title
Knee wobbling phenomenon to predict ACL injury risk in young female basketball athletes.
Scientific Title:Acronym
Knee wobbling to predict ACL injury
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the association between ACL inury and knee wobbling phenomenon
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee wobbling phenomenon
ACL injury occurrence
Key secondary outcomes
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy joining in sports activity less than 3 days per a week
Key exclusion criteria
previous ACL injury, previous bone fracture of lower extremity, abarticulation, pain during exercises, disability in balance, psychiatric disorder, who has problems with communication and understanding this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Gamada |
Organization
Hiroshima International University
Division name
Graduate School of Medical Technology and Health Welfare Sciences
Zip code
7392695
Address
555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan
TEL
0823704510
kazgamada@ortho-pt.com
Public contact
Name of contact person
| 1st name | Akino |
| Middle name | |
| Last name | Aoki |
Organization
Hiroshima International University
Division name
Graduate School of Medical Technology and Health Welfare Sciences
Zip code
7392695
Address
555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan
TEL
0823704510
Homepage URL
aj.spman154@gmail.com
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
None
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
Hiroshima International University
Address
555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan
Tel
0823704510
aj.spman154@gmail.com
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
| 2020 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Partially published
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
272
Results
There were no significant differences in knee kinematics and KW between those with and without subsequent ACL injuries. However, athletes who later suffered ACL injuries differed when classified by valgus or varus KW during slow single-leg squats compared to single-leg standing. Maximum knee valgus angle and varus KW were correlated (p = 0.025), as were varus KW and varus excursion angle (p=0.005).
Results date posted
| 2024 | Year | 05 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Young female basketball players
Participant flow
After recruitment for basketball team,
Adverse events
None
Outcome measures
Knee kinematics and characteristics of KW, which were classified into valgus and varus movement, were analyzed. KW was calculated as the ratio of knee frontal angular velocity to knee sagittal angular velocity. Participants with and without subsequent ACL injuries were compared after a three-year period.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Knee wobbling
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046054
