Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury
BANG
1 other identifier
interventional
169
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedOctober 3, 2023
October 1, 2023
4.2 years
May 20, 2019
October 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Return to sport rate
Rate of return to the preinjury sport and level of participation
At 1 year
Secondary Outcomes (12)
Self-reported participation in leisure time physical activity
Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up
New knee injuries
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
3 months, 6 months, 9 months, 1 year, 2 years
Knee Self-Efficacy Scale 'future' domain
Before surgery, 1 year, 2 years
Motivation to participate in leisure time physical activity
3 months, 6 months, 9 months
- +7 more secondary outcomes
Study Arms (2)
Usual care + Back in the Game
EXPERIMENTALSmartphone-delivered cognitive behavioural therapy to support confidence to return to sport + usual post-operative physiotherapy rehabilitation
Usual care
ACTIVE COMPARATORUsual post-operative physiotherapy rehabilitation
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- The Swedish Research Councilcollaborator
- Swedish Research Council for Sport Sciencecollaborator
- American Orthopaedic Society for Sports Medicinecollaborator
- Region Östergötlandcollaborator
- Psykologpartnerscollaborator
Study Sites (7)
Eksjö Hospital
Eksjö, 57533, Sweden
Capio Lundby
Gothenburg, 40276, Sweden
County Hospital Ryhov
Jönköping, 55305, Sweden
Linköping University Hospital
Linköping, 58183, Sweden
Capio Artro Clinic
Stockholm, 11428, Sweden
Praktikertjänst Orthopaedics
Stockholm, 11763, Sweden
Värnamo Hospital
Värnamo, 33152, Sweden
Related Publications (3)
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.
PMID: 32770983BACKGROUNDArdern 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.
PMID: 35943769BACKGROUNDRingberg M, Eldh AC, Ardern CL, Kvist J. Athletes' experiences of using a self-directed psychological support, the BAck iN the Game (BANG) smartphone application, during rehabilitation for return to sports following anterior cruciate ligament reconstruction. BMC Sports Sci Med Rehabil. 2023 Sep 19;15(1):113. doi: 10.1186/s13102-023-00731-2.
PMID: 37726848DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clare L Ardern, PhD
Department of Family Practice, University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
May 20, 2019
First Posted
May 22, 2019
Study Start
June 5, 2019
Primary Completion
July 31, 2023
Study Completion
July 31, 2024
Last Updated
October 3, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data must be requested through the Swedish National Data Service. Data will be available within 6 months of study completion and are available indefinitely.
- Access Criteria
- Requestors will be required to sign a Data Access Agreement.
Deidentified individual participant data for the primary and secondary outcomes will be shared with researchers whose proposed use has been approved by an independent review committee, for individual participant data meta-analysis.