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

Anterior Cruciate Ligament Injury Clinical Trial

— BANG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03959215
• Other study ID #: P2019-0174
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 5, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 169
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Wounds and Injuries

Intervention

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.

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.

Locations

Country	Name	City	State
Sweden	Eksjö Hospital	Eksjö
Sweden	Capio Lundby	Gothenburg
Sweden	County Hospital Ryhov	Jönköping
Sweden	Linköping University Hospital	Linköping
Sweden	Capio Artro Clinic	Stockholm
Sweden	Praktikertjänst Orthopaedics	Stockholm
Sweden	Värnamo Hospital	Värnamo

Sponsors (6)

Lead Sponsor	Collaborator
Karolinska Institutet	American Orthopaedic Society for Sports Medicine, Psykologpartners, Region Östergötland, Swedish Research Council for Sport Science, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Ardern CL, Hooper N, O'Halloran P, Webster KE, Kvist J. A Psychological Support Intervention to Help Injured Athletes "Get Back in the Game": Design and Development Study. JMIR Form Res. 2022 Aug 9;6(8):e28851. doi: 10.2196/28851. — View Citation

Ardern CL, Kvist J; BANG Trial Group. BAck iN the Game (BANG) - a smartphone application to help athletes return to sport following anterior cruciate ligament reconstruction: protocol for a multi-centre, randomised controlled trial. BMC Musculoskelet Disord. 2020 Aug 8;21(1):523. doi: 10.1186/s12891-020-03508-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to sport rate	Rate of return to the preinjury sport and level of participation	At 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Thigh muscle strength	We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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