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Anterior Cruciate Ligament InjuryBANGNCT03959215

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

A study testing Back in the Game and Usual rehabilitation care in people with Anterior Cruciate Ligament Injury, run by Karolinska Institutet at 7 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 15 to 30 years
Conditions the study is for
Anterior Cruciate Ligament Injury
What is being tested?
Back in the Game and Usual rehabilitation care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
7 sitesSweden
Study dates
5 Jun 2019to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Sweden7 sites

  • Eksjö Hospital

    Eksjö, 57533

  • Capio Lundby

    Gothenburg, 40276

  • County Hospital Ryhov

    Jönköping, 55305

  • Linköping University Hospital

    Linköping, 58183

  • Capio Artro Clinic

    Stockholm, 11428

  • Praktikertjänst Orthopaedics

    Stockholm, 11763

  • Värnamo Hospital

    Värnamo, 33152

Other trials in Sweden

About this study

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.

Being tested
Back in the Game, Usual rehabilitation care
Keywords
Knee injuries, Anterior cruciate ligament injuries, Telemedicine
Medical subject headings
Anterior Cruciate Ligament Injuries, Knee Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Back in the GameBehavioural

    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.

  • Usual rehabilitation careOther

    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.

Study groups in NCT03959215
Study groupRoleWhat they receive
Usual care + Back in the GameExperimentalSmartphone-delivered cognitive behavioural therapy to support confidence to return to sport + usual post-operative physiotherapy rehabilitation
Receives: Behavioral: Back in the Game
Usual careActive comparatorUsual post-operative physiotherapy rehabilitation
Receives: Other: Usual rehabilitation care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Return to sport rate

    Rate of return to the preinjury sport and level of participation

    Measured: At 1 year

Secondary outcomes (12)

  1. 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.

    Measured: Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up

  2. 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.

    Measured: Every 2 weeks from 10 weeks to 1-year follow-up; every month from 1 to 2 years follow-up

  3. 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.

    Measured: 3 months, 6 months, 9 months, 1 year, 2 years

  4. 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:

    1. How certain are you that you can return to the same physical activity level as before the injury?
    2. How certain are you that you would not suffer any new injuries to your knee?
    3. How certain are you that your knee would not 'break'?
    4. 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.

    Measured: Before surgery, 1 year, 2 years

  5. 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:

    1. How important is it for you to return to the same sport or recreation activity as before your knee injury?
    2. Do you think it is possible for you to return to the same sport or recreation activity as before your knee injury?
    3. How much time and effort are you willing to invest to return to the same sport or recreation activity as before your knee injury?

    Measured: 3 months, 6 months, 9 months

  6. 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.

    Measured: 1 year, 2 years

  7. 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.

    Measured: Before surgery, 6 months, 1 year, 2 years

  8. Thigh muscle strength

    We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.

    Measured: 1 year

  9. 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.

    Measured: 1 year

  10. 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.

    Measured: Every 2 weeks that the person is completing rehabilitation

  11. Adherence to smartphone intervention

    We will count page views for different types of content (including Vimeo for video content, Soundcloud for audio content).

    Measured: At 6 months

  12. 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.

    Measured: Before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start5 Jun 2019
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03959215
Sponsor's protocol ID
P2019-0174
Acronym
BANG
Status last verified
Oct 2023
First submitted
20 May 2019
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 32770983

  • 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.

    PubMed 35943769

  • Faltstrom A, Hedevik H, Ardern CL, Kvist J. Adding Self-directed Psychological Support to Usual Rehabilitation Following Anterior Cruciate Ligament Reconstruction Did Not Increase Return-to-Sport Rates at 12 Months. Results From the BAck iN the Game (BANG) Randomized Controlled Trial. J Orthop Sports Phys Ther. 2026 May;56(5):310-320. doi: 10.2519/jospt.2026.13749.

    PubMed 42063300

  • 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.

    PubMed 37726848

Questions about this trial

What is this clinical trial studying?

A study testing Back in the Game and Usual rehabilitation care in people with Anterior Cruciate Ligament Injury, run by Karolinska Institutet at 7 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return to sport rate (time frame: At 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03959215, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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