Cervicovestibular Rehabilitation and Aerobic Exercise in Children and Youth With Persistent Symptoms Following a Sport-related Concussion: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 主要终点
- Pediatric Quality of Life
研究概览
简要总结
Sport concussions are among the most commonly occurring injuries in sport and recreation and pose significant public health implications for Canadians. Many individuals who sustain a concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may suffer from persistent symptoms. Little research is currently available evaluating the effects of treatment for individuals who are slower to recover following sport-related concussion. An initial RCT identified a significant treatment effect in individuals with persistent symptoms of dizziness, neck pain and/or headaches following sport-related concussion when treated with a combination of cervical and vestibular physiotherapy compared to a typical protocol of rest followed by graded exertion (Schneider et al, 2014). Low level aerobic exercise in combination with sport specific training may also be of benefit to facilitate recovery in children and youth following concussion (Gagnon et al, 2009, 2016). Further evaluation of these treatments is required to better understand the effects of each treatment in isolation and in combination. This trial will have the ability to inform future multifaceted clinical trials as well as clinical practice. Ultimately, identification of optimal treatment paradigms will lead to a decrease in persistent symptoms and functional alterations in children and youth from this commonly occurring injury.
详细描述
Although awareness regarding sport-related concussion is growing, rehabilitative strategies for this commonly occuring injury have been a focus of very little research. With the exception of our pilot RCT, no RCTs to date have evaluated the efficacy of cervical spine physiotherapy in combination with vestibular rehabilitation in sport-related concussion. Current evidence has suggested positive effects of low-level aerobic exercise in youth and adults who are slow to recover following a concussion (Gagnon et al, 2016). However, low-level aerobic exercise has not yet been compared to cervicovestibular physiotherapy. A shift in clinical practice (to implement cervicovestibular physiotherapy or low level aerobic exercise) is occurring, but a direct comparison of the effects of low level aerobic exercise and multimodal physiotherapy treatment has not yet been conducted. A combination of these two forms of treatment may be more beneficial than either in isolation. Thus, the combination of physiotherapy and low level aerobic exercise treatment also requires evaluation. Identification of management strategies for individuals with persistent symptoms following concussion is urgently required to inform practice and optimize treatment strategies in this commonly occuring health problem.
OBJECTIVES:
Primary Research Question:
- Does cervical and vestibular rehabilitation (CVPT) 1) result in a greater proportion of individuals medically cleared to return to sport (yes/no); 2) improve quality of life compared to a control group of low level aerobic exercise (LLAE) (following an 8-week intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches following concussion)?
Secondary Research Questions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Ages 10-18 years of age
- •Diagnosed by the study sport medicine physician with a sport related concussion as per the 4th International Consensus guidelines
- •Persistent symptoms of dizziness, neck pain and/or headaches (>10 days and less than one year post injury) reported on the Sport Concussion Assessment Tool 3 (SCAT3) at initial or follow-up visit to the study sport medicine physician
- •Clinical findings suggesting cervical spine and/or vestibular involvement (i.e. limitations in cervical range of motion, positive clinical tests suggesting cervicogenic headaches, altered patterns of neuromotor control, alterations on dynamic visual acuity, dynamic balance, motion sensitivity, positive test for BPPV, etc)
排除标准
- •• Inability to participate in physical activity for a reason other than sport related concussion
- •Inability to communicate in English language
- •Neurodevelopmental delays
- •Other orthopaedic injury affecting ability to participate
- •Medication known to affect neural adaptation as they may alter the response to treatment
结局指标
主要结局
Pediatric Quality of Life
时间窗: Change from Initial assessment to 8 weeks
Paediatric Quality of Life Inventory (Peds-QL): The Pediatric Quality of Life Scale (PedsQL) is a measure of quality of life that is specific to children and measures four health domains including: Physical, emotional, social and school functioning. It is a measure that has demonstrated reliability and validity in multiple disease types in children, including traumatic brain injury.
Medical Clearance to return to sport
时间窗: 8 weeks
The primary outcomes of interest will be: 1) Medical clearance to return to sport by 8-weeks (as per the 4th International Consensus Guidelines on Concussion in Sport). Medical clearance was selected because it is the most clinically relevant measure and will reflect not only symptom resolution but also functional improvement. We have chosen to further standardize this outcome as follows to minimize risk of bias: 1. Asymptomatic a rest 2. Able to complete all steps of the return to play protocol with no recurrence of symptoms 3. Able to return to school full time without accommodations 4. No other clinical findings suggesting an inability to return to play Some individuals may choose not to return to sport (i.e. retire) or to have coaching decisions influence their return to sport (i.e. may return prior to medical clearance). Therefore, medical clearance to return to sport (as opposed to actual return) is felt to most accurately reflect recovery.
次要结局
- Walk While Talking Test(Change from Initial assessment to 8 weeks)
- Numeric Pain Rating Scale (Headache)(Change from Initial assessment to 8 weeks)
- Numeric Pain Rating Scale (Neck Pain)(Change from Initial assessment to 8 weeks)
- Patient Specific Functional Scale (PSFS)(Change from Initial assessment to 8 weeks)
- Sport Multidimensional Perfectionism Scale-2(Change from Initial assessment to 8 weeks)
- Connor-Davidson Resilience Scale(Change from Initial assessment to 8 weeks)
- Numeric Dizziness Rating Scale(Change from Initial assessment to 8 weeks)
- Activities-specific Balance Confidence Scale(Change from Initial assessment to 8 weeks)
- Actigraphy(Change from Initial Assessment to 8 weeks)
- Global Rating of Change(Change from Initial assessment to 8 weeks)
- Dizziness Handicap Inventory(Change from Initial assessment to 8 weeks)
- Dynamic Visual Acuity(Change from Initial assessment to 8 weeks)
- Balance Error Scoring System(Change from Initial assessment to 8 weeks)
- Head Thrust Test(Change from Initial assessment to 8 weeks)
- Vestibular/Ocular Motor Screen (VOMS)(Change from Initial assessment to 8 weeks)
- Joint Position Error (JPE)(Change from Initial assessment to 8 weeks)
- K6 Scale(Change from Initial assessment to 8 weeks)
- Supplemental Questions (Mrazick)(Change from Initial assessment to 8 weeks)
- Self-efficacy questionnaire for children (Gagnon et al, 2009)(Change from Initial assessment to 8 weeks)
- Functional Gait Assessment(Change from Initial assessment to 8 weeks)
- Motion Sensitivity Test(Change from Initial assessment to 8 weeks)
- Cervical Flexor Endurance(Change from Initial assessment to 8 weeks)
- Cervical Flexion Rotation Test (CFRT)(Change from Initial assessment to 8 weeks)
- Manual Spinal Examination (MSE)(Change from Initial assessment to 8 weeks)
- Sport Concussion Assessment Tool 3(Change from Initial assessment to 8 weeks)
- Palpation for Segmental Tenderness (PST)(Change from Initial assessment to 8 weeks)
- Cervical Rotation Side Flexion Test(Change from Initial assessment to 8 weeks)
研究者
KSchneider
Assistant Professor
Sport Injury Prevention Research Centre