Active intervention to treat persistent post-concussion symptoms in children and adolescents

Not Applicable

• Conditions: Concussion; Injuries and Accidents - Other injuries and accidents; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12617000418370
• Lead Sponsor: Prof Vicki Anderson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-23
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

•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:
Symptoms
•Somatic (e.g., headaches)
•Cognitive (e.g., feeling like in a fog)
•Emotional symptoms (e.g., lability)
Physical signs
•Loss of consciousness
•Amnesia
•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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post concussion symptoms as measured by the Post Concussion Symptom Inventory (PCSI), [Recruitment (presentation to the ED or via a referral network), screening (10 days post-injury), baseline (2 weeks + up to 7 days post-injury), the post-intervention assessment (3 months post-injury), and monitored every week during the intervention. ]