UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054085 |
|---|---|
| Receipt number | R000061673 |
| Scientific Title | Investigation into the Evolution of Continuous Tackling Posture Among Amateur Rugby Players for Injury Mitigation |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/02/04 21:01:30 |
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Basic information
Public title
Investigation into the Evolution of Continuous Tackling Posture Among Amateur Rugby Players for Injury Mitigation
Acronym
Investigation into the Evolution of Continuous Tackling Posture Among Amateur Rugby Players for Injury Mitigation
Scientific Title
Investigation into the Evolution of Continuous Tackling Posture Among Amateur Rugby Players for Injury Mitigation
Scientific Title:Acronym
Investigation into the Evolution of Continuous Tackling Posture Among Amateur Rugby Players for Injury Mitigation
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of temporal changes in tackle posture and height during consecutive tackles among amateur rugby players
Basic objectives2
Others
Basic objectives -Others
Verification of temporal changes in lower limb joint angles, muscle strength, head acceleration, and fatigue
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measurements taken by the three-dimensional motion analysis system include trunk and lower limb joint angles (hip, knee, ankle), tackling posture, and tackling height
Key secondary outcomes
Measurement of surveys, lower limb muscle strength(Countermovement Jump), and fatigue(Visual Analog Scale)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We will conduct measurements three times before the intervention and three times at the end of a total of 12 tackle movements: 10, 20, and 30 tackles. Tackles will be performed at maximum effort with a two-minute interval between each tackle. This protocol allows us to assess temporal changes in the measured variables.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A person with over one year of rugby experience
Key exclusion criteria
Individuals who do not consent to participate in the study, those unable to perform tackles due to injury, individuals undergoing treatment for medical or surgical conditions, and those who have experienced a previous concussion with a prolonged recovery time (21 days or more)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University
Division name
Department of Physical Therapy
Zip code
350-0496
Address
981 Kawakaku, Moroyama-cho, Iruma-gun, Saitama Prefecture.
TEL
0492951001
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
Department of Physical Therapy
Zip code
350-0496
Address
981 Kawakaku, Moroyama-cho, Iruma-gun, Saitama Prefecture.
TEL
0492951001
Homepage URL
akasaka-smc@umin.ac.jp
Sponsor or person
Institute
Saitama Medical University Department of Physical Therapy
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Department of Physical Therapy
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
Ethical Committee of Saitama Medical University
Address
38, Hongo, Moroyama-machi, Saitama
Tel
0492762143
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
| 2024 | Year | 05 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061673
