Effectiveness of personalized rehabilitation in adults suffering from persistent concussion symptoms as compared to usual care: a randomized control trial protocol

Abstract

Abstract Background Symptoms reported by patients who sustain a concussion are non-specific. As such, clinicians are better able to manage patients when a standardized clinical exam is performed to sub-type the driver(s) of symptoms. Aerobic exercise and multimodal rehabilitation have consistently shown to be a possibly effective means to manage this population; however, the optimal training prescription is unclear. Thus, 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. 50 participants will be recruited from out-patient University Health Network clinics and community-based clinical practices around the greater Toronto area. Participants will be randomized at baseline to Group A: a personalized care program followed by an active control or Group B: an active control followed by a personalized care program. Participants will be included should they be 21 years of age and older and have symptoms that have persisted beyond 4 weeks but less than 1 year. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6 weeks. At the end of 12 weeks, participants will undertake the endpoint examinations. The primary outcome will be the Rivermead Postconcussion Questionnaire (RPQ). The secondary outcomes will be changes in standardized clinical examination, Neck Disability Index (NDI), Patient Health Questionnaire (PHQ-9) and an electroencephalography (EEG) via NeuroCatch™. The statistical analysis to be performed is composed of 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.