- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03959215
Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury (BANG)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clare L Ardern, PhD
- Phone Number: +46 700 850 959
- Email: clare.ardern@ki.se
Study Contact Backup
- Name: Joanna Kvist, PhD
- Phone Number: +46 732 713 077
- Email: joanna.kvist@ki.se
Study Locations
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-
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Eksjö, Sweden, 57533
- Eksjö Hospital
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Gothenburg, Sweden, 40276
- Capio Lundby
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Jönköping, Sweden, 55305
- County Hospital Ryhov
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Linköping, Sweden, 58183
- Linkoping University Hospital
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Stockholm, Sweden, 11428
- Capio Artro Clinic
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Stockholm, Sweden, 11763
- Praktikertjänst Orthopaedics
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Värnamo, Sweden, 33152
- Värnamo Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Usual care + Back in the Game
Smartphone-delivered cognitive behavioural therapy to support confidence to return to sport + usual post-operative physiotherapy rehabilitation
|
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
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Return to sport rate
Time Frame: At 1 year
|
Rate of return to the preinjury sport and level of participation
|
At 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up
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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
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We will use an 'all complaints' definition of injury - participants self-report any new knee problems that have occurred during the surveillance window.
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Every 2 weeks from 10 weeks to 1-year follow-up; every month from 1 to 2 years follow-up
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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.
|
3 months, 6 months, 9 months, 1 year, 2 years
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Knee Self-Efficacy Scale 'future' domain
Time Frame: Before surgery, 1 year, 2 years
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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
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Motivation to participate in leisure time physical activity
Time Frame: 3 months, 6 months, 9 months
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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
Time Frame: 1 year, 2 years
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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
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Self-reported knee function (Single Assessment Numeric Evaluation (SANE) and International Knee Documentation Committee (IKDC) subjective knee form)
Time Frame: Before surgery, 6 months, 1 year, 2 years
|
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.
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Before surgery, 6 months, 1 year, 2 years
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Thigh muscle strength
Time Frame: 1 year
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We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.
|
1 year
|
Hopping performance
Time Frame: 1 year
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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
Time Frame: Every 2 weeks that the person is completing rehabilitation
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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.
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Every 2 weeks that the person is completing rehabilitation
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Adherence to smartphone intervention
Time Frame: At 6 months
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We will count page views for different types of content (including Vimeo for video content, Soundcloud for audio content).
|
At 6 months
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Hospital Anxiety and Depression Scale score
Time Frame: Before surgery
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Clare L Ardern, PhD, Department of Family Practice, University of British Columbia
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2019-0174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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