Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 169
- 试验地点
- 14
- 主要终点
- Return to sport rate
研究概览
简要总结
Returning to sport is one of the primary concerns of athletes following injury. Yet, after serious injury, up to 50% of athletes do not return to competitive sport. Psychological factors play an important role in the athlete's return to sport after anterior cruciate ligament (ACL) reconstruction, and physical and psychological readiness to return to sport often do not coincide. There are currently no easily accessible programs for non-professional athletes to help address the psychological factors that impact on their return to sport after injury.
The aim of this trial is to test whether a smartphone application (app) delivering cognitive-behavioural therapy to address psychological factors including fear, confidence and recovery expectations, is effective for improving the number of people who return sport following ACL reconstruction.
We hypothesise that patients who use the app in addition to receiving usual rehabilitation care after ACL reconstruction will return to sport in greater numbers than patients who receive usual rehabilitation care 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
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral primary anterior cruciate ligament rupture
- •Time between injury and anterior cruciate ligament reconstruction not greater than 12 months
- •Playing contact pivoting or non-contact pivoting sport at least twice per week prior to anterior cruciate ligament injury
- •Intend to return to sport following anterior cruciate ligament reconstruction
- •Age 15 to 30 years at anterior cruciate ligament injury
- •Normal/healthy contralateral knee
排除标准
- •Collateral ligament injury requiring surgery
- •Posterior cruciate ligament injury
- •Meniscus injury/treatment that requires alteration to usual rehabilitation programme
- •Articular cartilage injury/treatment that requires alteration to usual rehabilitation programme
- •Previous anterior cruciate ligament injury to either knee
- •Injury to either leg that required medical care during the previous 12 months
- •Other injury or illness that could affect knee rehabilitation
- •Taking medication for mental health problems
结局指标
主要结局
Return to sport rate
时间窗: At 1 year
Rate of return to the preinjury sport and level of participation
次要结局
- Motivation to participate in leisure time physical activity(3 months, 6 months, 9 months)
- Hopping performance(1 year)
- Adherence to physiotherapy(Every 2 weeks that the person is completing rehabilitation)
- Self-reported participation in leisure time physical activity(Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up)
- ACL- Return to sport after injury scale score(3 months, 6 months, 9 months, 1 year, 2 years)
- New knee injuries(Every 2 weeks from 10 weeks to 1-year follow-up; every month from 1 to 2 years follow-up)
- Knee Self-Efficacy Scale 'future' domain(Before surgery, 1 year, 2 years)
- ACL-Quality of Life scale score(1 year, 2 years)
- Self-reported knee function (Single Assessment Numeric Evaluation (SANE) and International Knee Documentation Committee (IKDC) subjective knee form)(Before surgery, 6 months, 1 year, 2 years)
- Hospital Anxiety and Depression Scale score(Before surgery)
- Thigh muscle strength(1 year)
- Adherence to smartphone intervention(At 6 months)
研究者
Clare Ardern
Senior Researcher
University of British Columbia