Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury (BANG)
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|ClinicalTrials.gov Identifier: NCT03959215|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : September 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injury||Behavioral: Back in the Game Other: Usual rehabilitation care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury|
|Actual Study Start Date :||June 5, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: Usual care + Back in the Game
Smartphone-delivered cognitive behavioural therapy to support confidence to return to sport + usual post-operative physiotherapy rehabilitation
Behavioral: Back in the Game
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.
Active Comparator: Usual care
Usual post-operative physiotherapy rehabilitation
Other: Usual rehabilitation care
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.
- Return to sport rate [ Time Frame: At 1 year ]Rate of return to the preinjury sport and level of participation
- Self-reported participation in leisure time physical activity [ Time Frame: Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up ]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.
- New knee injuries [ Time Frame: Every 2 weeks from 10 weeks to 1-year follow-up; every month from 1 to 2 years follow-up ]We will use an 'all complaints' definition of injury - participants self-report any new knee problems that have occurred during the surveillance window.
- ACL- Return to sport after injury scale score [ Time Frame: 3 months, 6 months, 9 months, 1 year, 2 years ]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.
- Knee Self-Efficacy Scale 'future' domain [ Time Frame: 1 year, 2 years ]
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.
- Motivation to participate in leisure time physical activity [ Time Frame: 3 months, 6 months, 9 months ]
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?
- ACL-Quality of Life scale score [ Time Frame: 1 year, 2 years ]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.
- Self-reported knee function (Single Assessment Numeric Evaluation and International Knee Documentation Committee subjective knee form) [ Time Frame: 6 months, 1 year, 2 years ]The item wording is: "on a scale from 0-100, where 100 represents the best, how would you rate your knee today?"
- Thigh muscle strength [ Time Frame: 1 year ]We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.
- Hopping performance [ Time Frame: 1 year ]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.
- Adherence to physiotherapy [ Time Frame: Every 2 weeks that the person is completing rehabilitation ]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.
- Adherence to smartphone intervention [ Time Frame: At 6 months ]We will count page views for different types of content (including Vimeo for video content, Soundcloud for audio content).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959215
|Contact: Clare L Ardern, PhD||+46 700 850 firstname.lastname@example.org|
|Contact: Joanna Kvist, PhD||+46 732 713 email@example.com|
|Eksjö, Sweden, 57533|
|Contact: Anne Fältström, PhD +46102426995 firstname.lastname@example.org|
|Gothenburg, Sweden, 40276|
|Contact: Stefan Pasula, PT +4631657179 email@example.com|
|Linköping University Hospital||Recruiting|
|Linköping, Sweden, 58183|
|Contact: Joanna Kvist, PhD +4613284664 firstname.lastname@example.org|
|Capio Artro Clinic||Recruiting|
|Stockholm, Sweden, 11428|
|Contact: Marita Harringe, PhD +46708838674 email@example.com|
|Värnamo, Sweden, 33152|
|Contact: Anne Fältström, PhD +46102426995 firstname.lastname@example.org|
|Principal Investigator:||Clare L Ardern, PhD||Division of Physiotherapy, Karolinska Institute|