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

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Back in the Game
Usual rehabilitation care
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Knee injuries, Anterior cruciate ligament injuries, Telemedicine

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eksjö Hospital
  • Capio Lundby
  • County Hospital Ryhov
  • Linköping University Hospital
  • Capio Artro Clinic
  • Praktikertjänst Orthopaedics
  • Värnamo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual care + Back in the Game

Usual care

Arm Description

Smartphone-delivered cognitive behavioural therapy to support confidence to return to sport + usual post-operative physiotherapy rehabilitation

Usual post-operative physiotherapy rehabilitation

Outcomes

Primary Outcome Measures

Return to sport rate
Rate of return to the preinjury sport and level of participation

Secondary Outcome Measures

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.
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.
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.
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: How certain are you that you can return to the same physical activity level as before the injury? How certain are you that you would not suffer any new injuries to your knee? How certain are you that your knee would not 'break'? 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.
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: How important is it for you to return to the same sport or recreation activity as before your knee injury? Do you think it is possible for you to return to the same sport or recreation activity as before your knee injury? How much time and effort are you willing to invest to return to the same sport or recreation activity as before your knee injury?
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.
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.
Thigh muscle strength
We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.
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.
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.
Adherence to smartphone intervention
We will count page views for different types of content (including Vimeo for video content, Soundcloud for audio content).
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.

Full Information

First Posted
May 20, 2019
Last Updated
October 2, 2023
Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council, Swedish Research Council for Sport Science, American Orthopaedic Society for Sports Medicine, Region Östergötland, Psykologpartners
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1. Study Identification

Unique Protocol Identification Number
NCT03959215
Brief Title
Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury
Acronym
BANG
Official Title
Back in the Game: a Smartphone Application to Support Athletes Returning to Sport After Serious Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
The Swedish Research Council, Swedish Research Council for Sport Science, American Orthopaedic Society for Sports Medicine, Region Östergötland, Psykologpartners

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
Knee injuries, Anterior cruciate ligament injuries, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care + Back in the Game
Arm Type
Experimental
Arm Description
Smartphone-delivered cognitive behavioural therapy to support confidence to return to sport + usual post-operative physiotherapy rehabilitation
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual post-operative physiotherapy rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Back in the Game
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual rehabilitation care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Return to sport rate
Description
Rate of return to the preinjury sport and level of participation
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Self-reported participation in leisure time physical activity
Description
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.
Time Frame
Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up
Title
New knee injuries
Description
We will use an 'all complaints' definition of injury - participants self-report any new knee problems that have occurred during the surveillance window.
Time Frame
Every 2 weeks from 10 weeks to 1-year follow-up; every month from 1 to 2 years follow-up
Title
ACL- Return to sport after injury scale score
Description
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.
Time Frame
3 months, 6 months, 9 months, 1 year, 2 years
Title
Knee Self-Efficacy Scale 'future' domain
Description
The 'future' domain of the knee self-efficacy scale comprises 4 questions to assess self-efficacy related to future knee function: How certain are you that you can return to the same physical activity level as before the injury? How certain are you that you would not suffer any new injuries to your knee? How certain are you that your knee would not 'break'? 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.
Time Frame
Before surgery, 1 year, 2 years
Title
Motivation to participate in leisure time physical activity
Description
We will use three questions all measured on a 1-10 scale, where higher scores represent higher motivation: How important is it for you to return to the same sport or recreation activity as before your knee injury? Do you think it is possible for you to return to the same sport or recreation activity as before your knee injury? How much time and effort are you willing to invest to return to the same sport or recreation activity as before your knee injury?
Time Frame
3 months, 6 months, 9 months
Title
ACL-Quality of Life scale score
Description
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.
Time Frame
1 year, 2 years
Title
Self-reported knee function (Single Assessment Numeric Evaluation (SANE) and International Knee Documentation Committee (IKDC) subjective knee form)
Description
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.
Time Frame
Before surgery, 6 months, 1 year, 2 years
Title
Thigh muscle strength
Description
We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.
Time Frame
1 year
Title
Hopping performance
Description
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.
Time Frame
1 year
Title
Adherence to physiotherapy
Description
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.
Time Frame
Every 2 weeks that the person is completing rehabilitation
Title
Adherence to smartphone intervention
Description
We will count page views for different types of content (including Vimeo for video content, Soundcloud for audio content).
Time Frame
At 6 months
Title
Hospital Anxiety and Depression Scale score
Description
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.
Time Frame
Before surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare L Ardern, PhD
Organizational Affiliation
Department of Family Practice, University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eksjö Hospital
City
Eksjö
ZIP/Postal Code
57533
Country
Sweden
Facility Name
Capio Lundby
City
Gothenburg
ZIP/Postal Code
40276
Country
Sweden
Facility Name
County Hospital Ryhov
City
Jönköping
ZIP/Postal Code
55305
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
58183
Country
Sweden
Facility Name
Capio Artro Clinic
City
Stockholm
ZIP/Postal Code
11428
Country
Sweden
Facility Name
Praktikertjänst Orthopaedics
City
Stockholm
ZIP/Postal Code
11763
Country
Sweden
Facility Name
Värnamo Hospital
City
Värnamo
ZIP/Postal Code
33152
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://snd.gu.se
Citations:
PubMed Identifier
32770983
Citation
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.
Results Reference
background
PubMed Identifier
35943769
Citation
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.
Results Reference
background

Learn more about this trial

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

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