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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
| Swedish Research Council for Sport Science | OTHER |
| American Orthopaedic Society for Sports Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care + Back in the Game | Experimental | Smartphone-delivered cognitive behavioural therapy to support confidence to return to sport + usual post-operative physiotherapy rehabilitation |
|
| Usual care | Active Comparator | Usual post-operative physiotherapy rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Back in the Game | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Return to sport rate | Rate of return to the preinjury sport and level of participation | At 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare L Ardern, PhD | Department of Family Practice, University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eksjö Hospital | Eksjö | 57533 | Sweden | |||
| Capio Lundby |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32770983 | Background | 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. | |
| 35943769 | Background |
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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.
Data must be requested through the Swedish National Data Service. Data will be available within 6 months of study completion and are available indefinitely.
Requestors will be required to sign a Data Access Agreement.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2020 | May 5, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Region Östergötland |
| OTHER |
| Psykologpartners | UNKNOWN |
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| Usual rehabilitation care | Other | 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. |
|
| 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:
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:
| 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 |
| 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 |
| 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. |
| 37726848 | Derived | Ringberg 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. |