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Evaluating implementation and clinical outcomes for the Murdoch Childrens Research Institute Concussion Centre

The Concussion Clinic Trial: Evaluating implementation and clinical outcomes of a digital health application and individualised multimodal interventions in children aged 8-17 years with persistent concussion symptoms

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001266550
Enrollment
325
Registered
2024-10-16
Start date
2024-10-17
Completion date
2026-02-28
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Clinical trial examining implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, implementation costs) and clinical outcomes of an intervention, delivered within a concussion clinic model. The trial will offer an innovative, integrated stepped-care model that provides individualised, evidence-based intervention and continuity of care for children and adolescents following the initial assessment and diagnosis of concussion in Emergency or Primary Care settings. Concussion Essentials is a proven effective intervention for treating concussion symptoms and can be implemented in routine clinical practice.

Interventions

Phase 1 (less than 2 weeks post-injury): Parents/participants who are less than 2 weeks at the time of recruitment/referral enrolment will: 1. Be asked to complete pre-treatment questionnaires and download the HeadCheck app. The HeadCheck app requires login details, which allows data entered in the app to be linked to the user. Parents/participants will be asked for consent to access their data from the HeadCheck app. Allowing the study to access this data will be optional. Data will be recorded

Phase 1 (less than 2 weeks post-injury): Parents/participants who are less than 2 weeks at the time of recruitment/referral enrolment will: 1. Be asked to complete pre-treatment questionnaires and download the HeadCheck app. The HeadCheck app requires login details, which allows data entered in the app to be linked to the user. Parents/participants will be asked for consent to access their data from the HeadCheck app. Allowing the study to access this data will be optional. Data will be recorded as missing for parents/participants who do not consent to study access of this data. 2. Complete a phone review with a study staff member at 2-3 weeks (14-21 days) post-injury to monitor symptoms, recovery, and activity participation. A phone review form on REDCap, with prompts will be used to guide this conversation and determine need for further clinical input. Any clinical issues will be escalated to a study clinician who may make additional phone contact with the participant if necessary. A phone review is completed in Phase 1 as it is expected that ~70% of children and adolescents will recover and return to usual activities in the 2-3 weeks post-injury. A phone review will help to distinguish between those who have recovered and those who may benefit from further clinical intervention (i.e., Phase 2). a. If the parent/guardian reports (i) a complete recovery, (ii) the participant has successfully returned to all usual activities without symptoms, and (iii) family have no concerns, they will be discharged from the service and sent completion questionnaires to complete via REDCap. If the questionnaires are not completed within 1-week of discharge from the service, they will receive two reminder emails/text messages and two reminder phone calls before being considered lost to follow up. REDCap is its own app/database which utilises easily accessible online surveys for research purposes. It is separate to HeadCheck b. If the parent/guardian reports persisting symptoms and/or does not meet the criteria outlined above, the participant will enter Phase 2. Phase 2 (>2 weeks to 3 months post-injury): Parents/participants who are >2 weeks to 3 months post-injury at the time of recruitment/referral enrolment will: 1. Book an initial appointment within the clinic. A link to complete pre-treatment questionnaires will be sent to participants with their appointment email. 2. Complete an initial appointment with the trial team (from 21-days post-injury). This initial appointment will be up to 1.5 hours long and may take up to 2 hours. 3. Continue with the CE/CE+ intervention (until symptom resolution, target discharge date by 8-weeks for those <3 months post-injury, target discharge date by 12-weeks for those >3 months post-injury). CE and CE+ refer to the names of a three-module intervention for early (CE) and chronic (CE+) persisting post-concussion symptoms. These interventions share the same three treatment modules (Education + Strategies - 'Concussion Essentials', Physiotherapy, Psychology). The key differences between these two interventions are (i) the length of time they were delivered (CE = up to 8 session intervention, CE+ = up to 12 session intervention), and (ii) the psychological treatment adopted (CE = Cognitive Behavioural Therapy, CE+ = Acceptance and Commitment Therapy). The CE/CE+ intervention provide individualised, symptom-targeted treatment. This means that the order and number of modules provided will differ from participant to participant. Every participant completes an initial session, which is interdisciplinary (physio and psychologist present) and includes an education + strategies module and physiotherapy module. Ongoing treatment decisions are made in weekly multi-disciplinary meetings, guided by clinician impression and symptom ratings. Participants and their families will largely complete intervention sessions via face-to-face consultations but where appropriate, will be provided the option to complete sessions via telehealth (e.g. Psychology modules). Education + Strategies - 'Concussion Essentials' module: Participants will receive education, strategies, and recommendations to manage various common symptoms following concussion, including headaches, fatigue, and sleep difficulties. Return to school and return to physical activity support is also provided within this module. Physiotherapy module: Participants will receive treatment targeting physiological, vestibular, ocular-motor, and cervicogenic systems, as required. This includes supported graded return to aerobic exercise. Participant may also receive a high-level return to play session dependent on the sport that they are returning to. This treatment is delivered by a physiotherapist and/or exercise physiologist with specific experience and training in concussion management. Physiotherapy exercises may include cervical, ocular, physiological, vestibular, or sport-specific drills/exercises. Treatment approaches of these physical systems are outlined below: • Physiological treatment: gradual increase in sub symptom cardiovascular exercise. A daily program of cardiovascular exercise (walk, run, bike, circuit etc.) may be prescribed at 85% of the treadmill sub-maximal test heart rate cut-off (monitored by heart rate monitors). Advice will be given on gradual exercise progression. • Cervicogenic treatment: Manual therapy may be administered at the clinic reviews. Home program may include sensorimotor training, strengthening, motor control exercises. • Ocular-motor treatment: Treatment involves ocular motor retraining. Daily home program may include the following ocular exercises: saccades, vergence, and smooth pursuit. • Vestibular treatment: Treatment will focus on simple vestibular exercises which will progress to more complex tasks. Daily home program may be prescribed which could include balance exercises, and motion sensitivity exercises. (NB. If participants have significant impairment in the cervical and ocular modules they will not be able to commence vestibular management until their other systems normalise.) • Return to sport: Specific return to sport drills incorporating the systems above may be prescribed to facilitate appropriate return to sport. Note that there will be slightly different protocols dependent on sports. Psychology module: Participants will receive evidence-based treatment based on principles of cognitive behaviour therapy (CBT) and/or Acceptance and Commitment Therapy (ACT). This module targets psychological symptoms (e.g., anxiety, depression, stress, avoidance) and is delivered by psychologists with specific experience and training in concussion management. a. Intervention sessions will be delivered weekly. b. Sessions may range from 30-to-90-minutes in length and include one or two of the available treatment modules. c. Specialist medical consultation will be available, if required (e.g., RCH rehab medicine, RCH psychiatry). d. Discharge - refer to discharge information. 4. Following discharge from the service, families will be sent completion questionnaires and complete an optional semi-structured interview.

Sponsors

Murdoch Childrens Research Institute
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

• Age between 8-17 years (or 18 year olds who are still in high school) • Diagnosis of concussion, confirmed by: o Evidence of a blow to the head or impulsive force transmitted to the head, and o 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 - 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) o No abnormalities on CT or MRI brain imaging, if performed

Exclusion criteria

The presence of any comorbidity that clinicians deem will be more appropriate for exclusive treatment within another health service/department (e.g., a patient with Functional Neurological Disorder (FND) may be referred to the FND team within the Victorian Paediatric Rehabilitation Service at Monash Health; or a patient with severe psychiatric diagnosis may be referred to RCH Psychiatry).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026