Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious I… (NCT03959215) | Clinical Trial Compass
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Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury
Sweden169 participantsStarted 2019-06-05
Plain-language summary
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.
Who can participate
Age range
15 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.