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

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ClinicalTrials.gov Identifier: NCT03959215
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : August 31, 2021
Sponsor:
Collaborators:
The Swedish Research Council
Swedish Research Council for Sport Science
American Orthopaedic Society for Sports Medicine
Region Östergötland
Psykologpartners
Information provided by (Responsible Party):
Clare Ardern, Karolinska Institutet

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Behavioral: Back in the Game Other: Usual rehabilitation care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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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
 Behavioral: Back in the Game

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
 Other: Usual rehabilitation care
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.


Outcome Measures
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Primary Outcome Measures :
  1. Return to sport rate [ Time Frame: At 1 year ]
    Rate of return to the preinjury sport and level of participation


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    We will use an 'all complaints' definition of injury - participants self-report any new knee problems that have occurred during the surveillance window.

  3. 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.

  4. Knee Self-Efficacy Scale 'future' domain [ Time Frame: Before surgery, 1 year, 2 years ]

    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.


  5. Motivation to participate in leisure time physical activity [ Time Frame: 3 months, 6 months, 9 months ]

    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?

  6. ACL-Quality of Life scale score [ Time Frame: 1 year, 2 years ]
    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.

  7. 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.

  8. Thigh muscle strength [ Time Frame: 1 year ]
    We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.

  9. Hopping performance [ Time Frame: 1 year ]
    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.

  10. Adherence to physiotherapy [ Time Frame: Every 2 weeks that the person is completing rehabilitation ]
    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.

  11. Adherence to smartphone intervention [ Time Frame: At 6 months ]
    We will count page views for different types of content (including Vimeo for video content, Soundcloud for audio content).

  12. Hospital Anxiety and Depression Scale score [ Time Frame: Before surgery ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959215


Contacts
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Contact: Clare L Ardern, PhD +46 700 850 959 clare.ardern@ki.se
Contact: Joanna Kvist, PhD +46 732 713 077 joanna.kvist@ki.se

Locations
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Sweden
Eksjö Hospital Recruiting
Eksjö, Sweden, 57533
Contact: Anne Fältström, PhD    +46102426995    anne.faltstrom@rjl.se   
Capio Lundby Recruiting
Gothenburg, Sweden, 40276
Contact: Stefan Pasula, PT    +4631657179    stefan.pasula@capio.se   
County Hospital Ryhov Recruiting
Jönköping, Sweden, 55305
Contact: Anne Fältström, PhD    +46102426995    anne.faltstrom@rjl.se   
Linköping University Hospital Recruiting
Linköping, Sweden, 58183
Contact: Joanna Kvist, PhD    +4613284664    joanna.kvist@liu.se   
Capio Artro Clinic Recruiting
Stockholm, Sweden, 11428
Contact: Marita Harringe, PhD    +46708838674    marita.harringe@ki.se   
Praktikertjänst Orthopaedics Recruiting
Stockholm, Sweden, 11763
Contact: Marita Harringe, PhD    +46708838674    marita.harringe@ki.se   
Värnamo Hospital Recruiting
Värnamo, Sweden, 33152
Contact: Anne Fältström, PhD    +46102426995    anne.faltstrom@rjl.se   
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Swedish Research Council for Sport Science
American Orthopaedic Society for Sports Medicine
Region Östergötland
Psykologpartners
Investigators
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Principal Investigator: Clare L Ardern, PhD Division of Physiotherapy, Karolinska Institute
  Study Documents (Full-Text)

Documents provided by Clare Ardern, Karolinska Institutet:
Informed Consent Form  [PDF] April 25, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clare Ardern, Senior Researcher, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03959215    
Other Study ID Numbers: P2019-0174
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: http://snd.gu.se

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clare Ardern, Karolinska Institutet:
Knee injuries
Anterior cruciate ligament injuries
Telemedicine
Additional relevant MeSH terms:
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Wounds and Injuries
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries