Effectiveness of personalized rehabilitation in adults suffering from persistent concussion symptoms as compared to usual care: a randomized control trial protocol
ABSTRACT
Symptoms reported by patients who sustain a concussion are non-specific. Clinicians can better manage patients by performing a standardized clinical exam to identify the underlying causes of symptoms. Aerobic exercise and multimodal rehabilitation have shown promise in managing this population, but the optimal training prescription is unclear. Therefore, there is a need to further examine the effectiveness of personalized rehabilitative treatments. Our primary aim is to evaluate the response to personalized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) when compared to an active control.
METHODS
We will conduct a multi-center 12-week case-crossover randomized controlled trial with 50 participants recruited from outpatient University Health Network clinics and community-based clinical practices around the greater Toronto area. Participants will be randomized to receive either a personalized care program followed by an active control or an active control followed by a personalized care program. The primary outcome will be the Rivermead Post-concussion Questionnaire (RPQ), with secondary outcomes including changes in standardized clinical examination, Neck Disability Index (NDI), Patient Health Questionnaire (PHQ-9), and electroencephalography (EEG) via NeuroCatch. Statistical analysis will be performed using an adjusted model using an analysis of variance, specifically using an unpaired t-test to test for associations between variables and outcomes.
DISCUSSION
Given the recommendations from reviews on the topic of rehabilitation for adults with persistent concussion symptoms, we are undertaking a controlled trial. The documented high costs for patients seeking care for persistent symptoms necessitate the need to evaluate the effectiveness of a personalized rehabilitative program compared to the current standard of care.
TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT06069700.
PMID:38987676 | DOI:10.1186/s12883-024-03700-5
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