PDF(Pubmed)
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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov ID: NCT06069700.
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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov ID: NCT06069700.
摘要：
背景：脑震荡患者报告的症状是非特异性的。因此，当进行标准化临床检查以区分症状的驱动因素时，临床医生能够更好地管理患者。有氧运动和多模式康复一直被证明是管理这一人群的可能有效的手段；然而，最佳训练处方尚不清楚.因此，有必要进一步检查个性化康复治疗的有效性。我们的主要目的是评估个性化治疗对康复的反应，通过Rivermead脑震荡后症状问卷（RPQ）与主动对照进行比较。
方法：我们将进行一项为期12周的多中心病例交叉随机对照试验。将从大多伦多地区的大学健康网络门诊诊所和社区临床实践中招募50名参与者。参与者将在基线时随机分配到A组：个性化护理计划，然后是主动对照或B组：主动对照，然后是个性化护理计划。如果参与者年龄在21岁及以上，并且症状持续超过4周但少于1年，则将包括在内。参与者将在各自的流中接受6周的护理。6周后,参与者将接受重新检查。然后他们将交叉并进行6周的替代治疗。在12周结束时，参与者将进行终点检查。主要结果将是Rivermead脑震荡后问卷（RPQ）。次要结果将是标准化临床检查的变化，颈部残疾指数(NDI)患者健康问卷(PHQ-9)和通过NeuroCatch™的脑电图(EEG)。要执行的统计分析由使用方差分析的调整模型组成，特别是使用非配对t检验来检验变量和结果之间的关联。
结论：鉴于有关患有持续性脑震荡症状的成年人康复的评论建议，我们正在进行对照试验.与当前的护理标准相比，为寻求持续症状护理的患者所记录的高成本需要评估个性化康复计划的有效性。
背景：ClinicalTrials.govID：NCT06069700。
方法：我们将进行一项为期12周的多中心病例交叉随机对照试验。将从大多伦多地区的大学健康网络门诊诊所和社区临床实践中招募50名参与者。参与者将在基线时随机分配到A组：个性化护理计划，然后是主动对照或B组：主动对照，然后是个性化护理计划。如果参与者年龄在21岁及以上，并且症状持续超过4周但少于1年，则将包括在内。参与者将在各自的流中接受6周的护理。6周后,参与者将接受重新检查。然后他们将交叉并进行6周的替代治疗。在12周结束时，参与者将进行终点检查。主要结果将是Rivermead脑震荡后问卷（RPQ）。次要结果将是标准化临床检查的变化，颈部残疾指数(NDI)患者健康问卷(PHQ-9)和通过NeuroCatch™的脑电图(EEG)。要执行的统计分析由使用方差分析的调整模型组成，特别是使用非配对t检验来检验变量和结果之间的关联。
结论：鉴于有关患有持续性脑震荡症状的成年人康复的评论建议，我们正在进行对照试验.与当前的护理标准相比，为寻求持续症状护理的患者所记录的高成本需要评估个性化康复计划的有效性。
背景：ClinicalTrials.govID：NCT06069700。
