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

NCT ID: NCT03959215

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual care + Back in the Game

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

Group Type EXPERIMENTAL

Back in the Game

Intervention Type BEHAVIORAL

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 care

Usual post-operative physiotherapy rehabilitation

Group Type ACTIVE_COMPARATOR

Usual rehabilitation care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Swedish Research Council for Sport Science

OTHER

Sponsor Role collaborator

American Orthopaedic Society for Sports Medicine

OTHER

Sponsor Role collaborator

Region Östergötland

OTHER

Sponsor Role collaborator

Psykologpartners

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Clare Ardern

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clare L Ardern, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Family Practice, University of British Columbia

Locations

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Eksjö Hospital

Eksjö, , Sweden

Site Status

Capio Lundby

Gothenburg, , Sweden

Site Status

County Hospital Ryhov

Jönköping, , Sweden

Site Status

Linköping University Hospital

Linköping, , Sweden

Site Status

Capio Artro Clinic

Stockholm, , Sweden

Site Status

Praktikertjänst Orthopaedics

Stockholm, , Sweden

Site Status

Värnamo Hospital

Värnamo, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 32770983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35943769 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37726848 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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P2019-0174

Identifier Type: -

Identifier Source: org_study_id

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