UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050572 |
|---|---|
| Receipt number | R000057604 |
| Scientific Title | Previous concussion and postural changes due to tackle height in college rugby players |
| Date of disclosure of the study information | 2023/04/12 |
| Last modified on | 2024/09/15 07:40:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Previous concussion and postural changes due to tackle height in college rugby players
Acronym
Previous concussion and postural changes due to tackle height in college rugby players
Scientific Title
Previous concussion and postural changes due to tackle height in college rugby players
Scientific Title:Acronym
Previous concussion and postural changes due to tackle height in college rugby players
Region
| Japan |
Condition
Condition
nothng
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of a history of concussion in college rugby players on head acceleration and tackle posture at different tackle heights.
Basic objectives2
Others
Basic objectives -Others
To determine the effect of a history of concussion in college rugby players on head acceleration and tackle posture at different tackle heights.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of Tackle Motion by 3-Dimensional Motion Analyzer
Key secondary outcomes
questionnaire
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
The tackle dummy is assisted from 4.5m away and three different heights optimal,high,and low are used to tackle the tackle dummy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
college rugby player
Key exclusion criteria
(1) Persons who cannot give their consent to participate in this study.
(2) Those who are currently absent from club activities due to injury.
(3) Those with orthopedic conditions that are currently under treatment.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Graduate school of Saitama Medical University
Division name
Department of Medicine
Zip code
350-0436
Address
981 Kawakado, Moroyama, Saitama, Japan
TEL
049-295-1001
northriver12537@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kitagawa |
Organization
Graduate school of Saitama Medical University
Division name
Department of Medicine
Zip code
350-0436
Address
981 Kawakado, Moroyama, Saitama, Japan
TEL
049-295-1001
Homepage URL
northriver12537@gmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
Saitama Medical University Ethics Review Committee
Address
38. Morohongou. Moroyama. Iruma. Saitama.
Tel
049-276-2143
ethics@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
| 2023 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
Not applicable.
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable.
Number of participants that the trial has enrolled
19
Results
Head angular acceleration showed no interaction with the presence or absence of a concussion history and tackle height (p>0.05). There was a main effect of tackle height on the rotational direction (p<0.05). There was no interaction between lower limb joint flexion angles (hip, knee, and ankle joints), concussion history, and tackle height (p>0.05). However, hip and knee joint flexion angles showed a main effect of tackle height (p<0.05).
Results date posted
| 2024 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were male rugby players affiliated with the university, as markers for the three-dimensional motion analysis system needed to be attached to their entire bodies, and consent was obtained for measurements conducted by male assessors. Exclusion criteria included individuals who did not consent to participate, those who were currently resting from activities due to injuries, and those with ongoing orthopedic conditions under treatment.
Participant flow
Materials for the study were sent to university rugby teams in Saitama Prefecture, and 19 individuals who provided consent were included in the study. A questionnaire was administered to group participants based on the presence or absence of a concussion history (hereafter referred to as the 'history group' and 'no history group'). Subsequently, measurements were taken using a three-dimensional motion analysis system to assess head angular acceleration and lower limb joint angles during tackles at two different heights.
Adverse events
Not applicable.
Outcome measures
The three-dimensional motion analysis system (Vicon MX System, Vicon Motion Systems, Oxford, UK) was used for the study. Participants tackled a stationary tackle dummy (SUZUKI RUGBY Hard Tackle Dummy SD-903) from a distance of 4.5 meters with maximum effort. Tackles were classified as high if they were between 83 cm and 136 cm from the ground, and low if they were between 45 cm and 83 cm. Each participant performed tackles at both heights in a randomized order, with five repetitions for each height. The tackle dummy was marked at positions 110 cm and 64 cm, and participants were instructed to aim for these positions. Tackles that did not meet the defined criteria, tackles involving a diving motion, or cases where the tackle dummy did not fall in the direction of the tackle were excluded from the analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057604
