Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Post Concussion Symptoms
研究概览
简要总结
The purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.
详细描述
There is a portion of youth who continue to experience persistent post-concussion symptoms beyond the first few weeks of injury. There is limited evidence with respect to the best ways to treat persistent post-concussion symptoms in youth following concussion. There is a small amount of literature that suggests active rehabilitation as a positive intervention for promotion of recovery of persistent post-concussion symptoms. However, this approach to rehabilitation has yet to be explored using a randomized control trial protocol.
Therefore, this study aims to answer the following question: Is a 6 week active rehabilitation program in combination with a comprehensive education intervention (standard care) effective in reducing post-concussive symptoms and improving functional recovery compared to receiving comprehensive education intervention alone among youth experiencing persistent post-concussion symptoms?
We hypothesize:
- youth ages 10 to 18 years who present with persistent self-reported post-concussion symptoms 4 weeks after the initial injury and receive the active rehabilitation intervention, will present with decreased post-concussion symptoms at the completion of the intervention.
- youth ages 10 to 18 years who receive the active rehabilitation intervention, will present with more complete functional recovery and increased participation in unrestricted physical activity at the completion of the active rehabilitation intervention compared to children receiving the comprehensive education intervention only
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
- •confirmed diagnosis of concussion
- •have at least one post-concussion symptom (as measured by the Post Concussion Symptom Inventory)
- •are at least 4 weeks post injury
- •between the ages of 10 and 18 years
- •ability to speak English
- •ability to demonstrate capacity to consent to study
排除标准
- •prior moderate or severe brain injury
- •neck pain/dysfunction or oculormotor/vestibular dysfunction, developmental delays, mental health disorders or chronic pain conditions that prevent participation in active rehabilitation, assessment of gait and balance, or participation in cognitive testing
- •participating in any other physical rehabilitation interventions for post-concussion symptoms (e.g., physiotherapy, massage therapy, chiropractic) at time of enrollment and throughout the duration of the study
研究组 & 干预措施
Active Rehabilitation
Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)
干预措施: Active Rehabilitation (Other)
Active Rehabilitation
Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)
干预措施: Comprehensive Education Intervention (Standard Care) (Other)
Comprehensive Education Intervention
Comprehensive Education Intervention (Standard Care) only
干预措施: Comprehensive Education Intervention (Standard Care) (Other)
结局指标
主要结局
Post Concussion Symptoms
时间窗: Week 6 (upon completion of intervention)
The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
Post-Concussion Symptoms
时间窗: Week 0 (Baseline)
The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
Post Concussion Symptoms
时间窗: Week 2
The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
次要结局
- Quality of Life Level(Week 6 (upon completion of the intervention))
- Balance(Week 6 (upon completion of intervention))
- Mood(Week 6 (upon completion of the intervention))
- Behavior(Week 6 (upon completion of the intervention))
- Energy Level(Week 6 (upon completion of the intervention))
- SCAT Balance(Week 0 (Baseline))
- Satisfaction Level(Week 6 (upon completion of the intervention))
- Anxiety(Week 6 (upon completion of the intervention))
- Neurocognitive(Week 6 (upon completion of the intervention))
- Activity Participation(Week 2)
- Acute Concussion Evaluation(Week 0 (Baseline))
- Occupational Performance(Week 6 (upon completion of the intervention))
- Mood(Week 0 (Baseline))
- Behavior(Week 0 (Baseline))
- Energy Level(Week 0 (Baseline))
- Quality of Life Level(Week 0 (Baseline))
- Balance(Week 0 (Baseline))
- Balance(Week 6 (upon completion of the intervention))
- Neurocognitive(Week 0 (Baseline))
- Anxiety(Week 0 (Baseline))
- Activity Participation(Week 0 (Baseline))
- Satisfaction Level(Week 0 (Baseline))
- Occupational Performance(Week 0 (Baseline))
- Activity Participation(Week 6 (upon completion of the intervention))