Active Rehabilitation for Slow to Recover Adolescents Following Sport-Related Concussion: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Symptom Report
研究概览
简要总结
To test the safety and feasibility of a new treatment for adolescents who are slow to recover from a sport-related concussion, the investigators are conducting a randomised controlled trial comparing treatment as usual with an active rehabilitation program that involves sub-symptom threshold cardiac exertion, sport-specific coordination activities, and positive visualisation techniques.
详细描述
Most adolescents recover within the first month following a sport-related concussion. However, some do not. Little is known about how to best facilitate recovery when symptoms do not resolve spontaneously and swiftly. Although active rehabilitation has been recently suggested as a promising means of promoting recovery, current literature does not provide adequate evidence for safe adaptation into clinical practice.
Objective: The purpose of this project is to evaluate an active rehabilitation protocol for adolescents who are slow to recover following sport-related concussion. Primary aims: to confirm the tolerability and safety of the active rehabilitation protocol as compared to treatment as usual controls. Secondary aims: 1) to document the impact of active rehabilitation on post-concussion symptoms and return to activity; 2) to explore the intervention effects on quality of life, mood, energy level, balance, cognitive functioning, and return to pre-injury activities.
Study design: A parallel group open label randomized comparison trial of 30 adolescents who are slow to recover following sport-related concussion. After initial screening and assessment, both groups will receive treatment as usual. Participants in the experimental group will also participate in sub-symptom threshold exercise, sport-specific coordination practice, and positive visualisation daily.
Outcome measures: The investigators will monitor for adverse events and assess post-concussion symptoms throughout the study as a primary marker of recovery. The investigators will also report secondary outcomes such as quality of life, mood, energy level, balance and cognitive functioning. Finally the investigators will record rates of return to school (full time, part time) and rates of return to sport (regular pre-injury vs. modified level). As a result, clinicians will be able to follow a new rehabilitation protocol in a safe and meaningful way. Lastly, research findings will be disseminated in the form of a publication, at conferences, and via in-services.
Hypotheses:
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
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents referred to G. F. Strong Rehabilitation Centre (GFS) for atypical recovery preventing them from entering standard return to activities protocols will be recruited on a voluntary basis to participate in this study.
- •Eligibility criteria for study entry are as follows:
- •sustained an injury in sports,
- •are 4 weeks post injury,
- •report 2+ persistent post-concussion symptoms with no significant improvement over the past week,
- •are between the ages of 14 and 18,
- •have no developmental, congenital, or cognitive diagnoses,
- •have no active mental health disorders,
- •are able to attend at GFS,
- •speak English as their dominant language,
- •have no prior moderate or severe TBI,
- •have no concussion in the 6 months before the present injury, and
- •medical clearance by the study physician.
排除标准
- 未提供
研究组 & 干预措施
Treatment-as-usual (TAU)
The TAU program will be implemented after the initial assessment. It will consist of 2 components:
- An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms
- A school consultation to provide teacher education, recommend accommodations, and facilitate return to school
干预措施: Treatment-as-usual (TAU) (Behavioral)
Behavioral:Active Rehabilitation Program
The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below:
- Sub-maximal aerobic training for up to 15 minutes
- Light coordination and sport-specific exercises for up to 10 minutes
- Visualization and imagery techniques
- Home program.
A physiotherapist will supervise the rehabilitation.
干预措施: Active Rehabilitation Program (Behavioral)
结局指标
主要结局
Symptom Report
时间窗: At 8 weeks (end-of-treatment)
Symptom Report
时间窗: Baseline
The Post-Concussion Scale consists of 22 subjectively-experienced symptoms (e.g., headache, dizziness, concentration problems, and fogginess). A total score is derived from this 22-item scale. Athletes report symptoms based on the severity of each symptom that day, allowing tracking of symptoms over very short intervals
次要结局
- Return to School and Sport(At 8 weeks (end-of-treatment))
- Mood(At 8 weeks (end-of-treatment))
- Energy level(At 8 weeks (end-of-treatment))
- Neurocognitive Testing(At 8 weeks (end-of-treatment))
- Balance Testing(At 8 weeks (end-of-treatment))
- Mood(Baseline)
- Energy level(Baseline)
- Balance Testing(Baseline)
- Neurocognitive Testing(Baseline)
- Return to School and Sport(Baseline)