Clinical trial NCT03959215: Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury
Official title: Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: Knee injuries
Anterior cruciate ligament injuries
Telemedicine
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Swedish Research Council for Sport Science
name: American Orthopaedic Society for Sports Medicine
name: Region Östergötland
name: Psykologpartners
First posted: 2019-05-22
Enrollment: 169
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Return to sport rate
timeFrame: At 1 year
Secondary outcomes:
measure: Self-reported participation in leisure time physical activity
timeFrame: Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up
measure: New knee injuries
timeFrame: Every 2 weeks from 10 weeks to 1-year follow-up; every month from 1 to 2 years follow-up
measure: ACL- Return to sport after injury scale score
timeFrame: 3 months, 6 months, 9 months, 1 year, 2 years
measure: Knee Self-Efficacy Scale 'future' domain
timeFrame: Before surgery, 1 year, 2 years
measure: Motivation to participate in leisure time physical activity
timeFrame: 3 months, 6 months, 9 months
measure: ACL-Quality of Life scale score
timeFrame: 1 year, 2 years
measure: Self-reported knee function (Single Assessment Numeric Evaluation (SANE) and International Knee Documentation Committee (IKDC) subjective knee form)
timeFrame: Before surgery, 6 months, 1 year, 2 years
measure: Thigh muscle strength
timeFrame: 1 year
measure: Hopping performance
timeFrame: 1 year
measure: Adherence to physiotherapy
timeFrame: Every 2 weeks that the person is completing rehabilitation
measure: Adherence to smartphone intervention
timeFrame: At 6 months
measure: Hospital Anxiety and Depression Scale score
timeFrame: Before surgery
Other outcomes:
Locations:
city: Eksjö
country: Sweden
facility: Eksjö Hospital
city: Gothenburg
country: Sweden
facility: Capio Lundby
city: Jönköping
country: Sweden
facility: County Hospital Ryhov
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Stockholm
country: Sweden
facility: Capio Artro Clinic
city: Stockholm
country: Sweden
facility: Praktikertjänst Orthopaedics
city: Värnamo
country: Sweden
facility: Värnamo Hospital
Study officials:
affiliation: Department of Family Practice, University of British Columbia
name: Clare L Ardern, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.