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

October 2, 2023 updated by: Clare Ardern, Karolinska Institutet

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

Active, not recruiting

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Eksjö, Sweden, 57533
        • Eksjö Hospital
      • Gothenburg, Sweden, 40276
        • Capio Lundby
      • Jönköping, Sweden, 55305
        • County Hospital Ryhov
      • Linköping, Sweden, 58183
        • Linkoping University Hospital
      • Stockholm, Sweden, 11428
        • Capio Artro Clinic
      • Stockholm, Sweden, 11763
        • Praktikertjänst Orthopaedics
      • Värnamo, Sweden, 33152
        • Värnamo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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
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
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.
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
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
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.

Before surgery, 1 year, 2 years
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?
3 months, 6 months, 9 months
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.
1 year, 2 years
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.
Before surgery, 6 months, 1 year, 2 years
Thigh muscle strength
Time Frame: 1 year
We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.
1 year
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.
1 year
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.
Every 2 weeks that the person is completing rehabilitation
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).
At 6 months
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.
Before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Clare L Ardern, PhD, Department of Family Practice, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2019

Primary Completion (Actual)

July 31, 2023

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing Access Criteria

Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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