Developing an evidence-base for preventing and treating delayed symptoms of concussion in children and adolescents: a randomised controlled clinical trial

Prof Vicki Anderson0 个研究点目标入组 216 人开始时间: 2017年3月23日最近更新: 2019年8月26日

试验速览

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•Age between 8-18 years (at time of randomisation)
•History of concussion up to 10 days prior to ED presentation or referral
•Concussion diagnosis will be confirmed by;Evidence of a blow to the head or impulsive force transmitted to the head; One or more of the following:
•Somatic (e.g., headaches)
•Cognitive (e.g., feeling like in a fog)
•Emotional symptoms (e.g., lability)
•Physical signs
•Loss of consciousness
•Neurological deficit
•Balance impairment (e.g., gait unsteadiness)
•Behavioural changes (e.g., irritability)
•Cognitive impairment (e.g., slowed reaction times)
•Sleep/wake disturbance (e.g., somnolence, drowsiness)
•Glasgow Coma Score (GCS) 13-15
•PPCS at 2 (+ up to 7 days)weeks’ post-injury
•PPCS will be defined as endorsement >= 2 PCS on the PCSI, over and above those endorsed pre-injury at the baseline assessment

•Patients meeting any of the following criteria will be excluded from the study:
•Injury related:
•oUnknown time or mechanism of injury
•oNon-accidental injury
•oHead injury secondary to faint/collapse/seizure
•oStructural brain injury on conventional neuroimaging (CT or MRI)
•oMultiple trauma
•oCervical spine injury (clinical and/or radiological)
•Pre-existing conditions:
•oCongenital neuro-ophthalmological or vestibular dysfunction
•oCentral neurological conditions (e.g., stroke, uncontrolled or unmanaged epilepsy,
•moderate to severe brain injury)
•oSevere mental health history (e.g., actively suicidal, substance abuse, bipolar or
•psychotic disorders)
•Researcher judgement of inability to complete study program:
•oComplex psychosocial history (e.g., family violence, child protection involvement, etc.)
•oPre-existing developmental disorders (not in mainstream school, or in mainstream
•school with a teaching aide)
•oInsufficient English to complete study requirements
•oInability to attend on-site visits

发起方

Prof Vicki Anderson