Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia
School of Psychological Sciences, University of Melbourne, Parkville, Victoria, Australia.
BMJ Open. 2021 Feb 11;11(2):e041458. doi: 10.1136/bmjopen-2020-041458.
While most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.
In this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8-18 years will be recruited from The Royal Children's Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child's PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.
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.
ACTRN12617000418370; pre-results.
虽然大多数儿童在受伤后不久就能从脑震荡中恢复，但仍有约 30%的儿童在受伤后 1 个月以上持续出现脑震荡后症状（pPCS）。现有的 pPCS 治疗研究评估了单一模式的方法，尽管有证据表明 pPCS 可能代表了各种症状群之间的相互作用。本研究的主要目的是评估一种多模式、症状针对性干预措施的有效性，以加速症状恢复，并增加 3 个月时症状缓解的儿童比例。
这是一项开放标签、评估者盲法、随机临床试验，将从 The Royal Children's Hospital（RCH）急诊科招募年龄在 8-18 岁的脑震荡儿童，或由临床医生在受伤后 17 天内转介。根据父母在受伤后约 10 天对孩子的 pPCS 评分，有症状的儿童（≥2 个症状，至少比受伤前高 1 分）将在受伤后 3 周进行基线评估，并随机分为脑震荡基础治疗（CE，n=108）或常规护理（UC，n=108）组。CE 组参与者将每周接受 1 小时的干预，最多 8 周或直到 pPCS 缓解。所有参与者将在受伤后 3 个月进行方案后评估。CE 干预的有效性将通过方案后评估时 pPCS 缓解的参与者比例来确定（主要结局）与 UC 组相比。次要结局分析将检查接受 CE 的儿童是否更有可能缓解 pPCS，更早恢复正常活动，更高的生活质量，以及使用卫生服务的比率更低，与 UC 组相比。
该研究已获得 RCH 人类研究伦理委员会（HREC：37100）的批准。在试验开始前，将获得家长的同意（对于成熟的未成年人，还需获得参与者的同意）。研究结果将在国际会议和国际同行评议期刊上发表。
ACTRN12617000418370；预结果。
