Vanessa Xxx Mature

Vanessa Xxx Mature

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Ethics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.

Interim analyses are not planned for this trial. There are no stopping guidelines; individual participants from both groups are monitored by physiotherapists and psychologists throughout their participation in the study. Premature closure and extension of the trial will depend on funding and the number of adverse events. The decision to close or extend the trial will be made by the principal investigator or TSC. The principal investigator and trial statistician will have access to the final trial dataset.

Ethical approval was obtained through The RCH Human Research Ethics Committee (HREC: 37100). The RCH ethics committee will approve all protocol modifications. Participant confidentiality is strictly held in trust by the participating investigators, research staff and sponsoring institution. RAs obtain (1) electronic consent from parents for screening and recruitment and (2) informed written consent from parents for all participants at the start of the baseline assessment. Written consent is also obtained from participants aged 13 years and older at baseline, who are considered mature minors. The study poses little to no risk to participants and their families. Participation in the study is voluntary and does not interfere with typical care patients receive in the ED or in the community. Clinicians provide clinical treatment as part of the intervention and, if necessary, participants are referred for additional clinical care at the completion of their involvement in the study. Participants can withdraw consent at any time. Results from this study will be disseminated at regional and international conferences and in peer-reviewed journals. Findings may also result in changes to hospital or community policies and procedures regarding clinical concussion management. Authorship eligibility will be consistent with International Committee of Medical Journal Editors guidelines.

By using a sample and definition of concussion that is not sport specific, the findings are generalisable to a broad population of children. Furthermore, concussions may be downplayed or overlooked by parents and children. A study of high school footballers found that up to 50% of concussions went unreported, mainly due to unawareness of the seriousness of the injury, a desire to immediately return to play, and lack of awareness of concussion.56 Premature return to normal activity can heighten the risk of further injury, including repeat concussion.57 The current study will promote psychoeducation on concussion and graded return to aerobic activity, and encourage participants to monitor symptoms which may be non-specific and which they may not otherwise readily associate with the concussion. 59ce067264

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