Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury

Study Overview
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Brief Summary
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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.

Official Title
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Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury

Conditions
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Anterior Cruciate Ligament Injury

Intervention / Treatment
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* Behavioral: Back in the Game
* Other: Usual rehabilitation care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual care + Back in the Game<br>Smartphone-delivered cognitive behavioural therapy to support confidence to return to sport + usual post-operative physiotherapy rehabilitation | Behavioral: Back in the Game<br>* A six-month programme of cognitive-behavioural therapy delivered by smartphone application. The intervention commences in the first week after ACL reconstruction. The smartphone app is delivered in parallel with usual rehabilitation care. Usual rehabilitation care: all participants will be referred to physiotherapy following ACL reconstruction. Overall treatment aims, content and progressions of rehabilitation will follow current clinical guidelines. The choice of specific therapies, exercises and the number of treatment sessions needed to achieve the treatment aims is at the clinical discretion of the treating physiotherapist.<br>|
| Active Comparator: Usual care<br>Usual post-operative physiotherapy rehabilitation | Other: Usual rehabilitation care<br>* Following ACL reconstruction, as per routine clinical practice, all participants will be referred to physiotherapy. Overall treatment aims, content and progressions of rehabilitation will follow current clinical guidelines. The choice of specific therapies, exercises and the number of treatment sessions needed to achieve the required treatment aims is at the clinical discretion of the treating physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to sport rate | Rate of return to the preinjury sport and level of participation | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported participation in leisure time physical activity | Every two weeks, participants will report the number of minutes spent in physical activity and the number of physical activity sessions including, but not limited to knee physiotherapy/rehabilitation sessions, active recreation, training and competitive sport. | Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up | 
| New knee injuries | We will use an 'all complaints' definition of injury - participants self-report any new knee problems that have occurred during the surveillance window. | Every 2 weeks from 10 weeks to 1-year follow-up; every month from 1 to 2 years follow-up | 
| ACL- Return to sport after injury scale score | The ACL-Return to sport after injury scale (ACL-RSI) is a 12-item scale designed to measure psychological readiness to return to sport after ACL injury. Scores range from 0 to 100; higher scores indicate greater psychological readiness to return to sport. | 3 months, 6 months, 9 months, 1 year, 2 years | 
| Knee Self-Efficacy Scale 'future' domain | The 'future' domain of the knee self-efficacy scale comprises 4 questions to assess self-efficacy related to future knee function: How certain are you that you can return to the same physical activity level as before the injury? How certain are you that you would not suffer any new injuries to your knee? How certain are you that your knee would not 'break'? How certain are you that your knee will not get worse than before surgery? Each question is scored on a 0-10 scale (higher scores represent greater self-efficacy). The domain score is the mean of responses to the four questions. | Before surgery, 1 year, 2 years | 
| Motivation to participate in leisure time physical activity | We will use three questions all measured on a 1-10 scale, where higher scores represent higher motivation: How important is it for you to return to the same sport or recreation activity as before your knee injury? Do you think it is possible for you to return to the same sport or recreation activity as before your knee injury? How much time and effort are you willing to invest to return to the same sport or recreation activity as before your knee injury? | 3 months, 6 months, 9 months | 
| ACL-Quality of Life scale score | The ACL-QoL is a 30-item scale to measure knee-related quality of life following ACL injury. Scores range from 0 to 100; higher scores indicate greater knee-related quality of life. | 1 year, 2 years | 
| Self-reported knee function (Single Assessment Numeric Evaluation (SANE) and International Knee Documentation Committee (IKDC) subjective knee form) | The item wording for SANE is: on a scale from 0-100, where 100 represents the best, how would you rate your knee today? The IKDC subjective knee form is a 19-item condition-specific measure. The IKDC is scored out of 100 points, with a higher score indicating superior self-reported knee function. | Before surgery, 6 months, 1 year, 2 years | 
| Thigh muscle strength | We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque. | 1 year | 
| Hopping performance | We will measure the single hop for distance, triple hop for distance and side hop test for the affected and unaffected sides. The single hop for distance is the maximum distance the person can hop from a stationary starting position. The triple hop for distance is the maximum distance the person can hop with three successive hops from a stationary starting position. The side hop test is the number of hops the person can complete side-to-side over a 40cm strip of tape, in a 30 second period. If the person steps on the tape, the test must stop and be repeated. | 1 year | 
| Adherence to physiotherapy | Participants will self-report the number of supervised physiotherapy sessions, number of home-based exercise sessions and the number of gym-based exercise sessions completed in the previous 2 weeks. | Every 2 weeks that the person is completing rehabilitation | 
| Adherence to smartphone intervention | We will count page views for different types of content (including Vimeo for video content, Soundcloud for audio content). | At 6 months | 
| Hospital Anxiety and Depression Scale score | The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale that measures psychological distress. Scores range from 0 to 21; higher scores indicate greater psychological distress. | Before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee injuries, Anterior cruciate ligament injuries, Telemedicine