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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
169
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.
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.
Eksjö Hospital
Eksjö, Sweden
Capio Lundby
Gothenburg, Sweden
County Hospital Ryhov
Jönköping, Sweden
Linköping University Hospital
Linköping, Sweden
Capio Artro Clinic
Stockholm, Sweden
Praktikertjänst Orthopaedics
Stockholm, Sweden
Värnamo Hospital
Värnamo, Sweden
Return to sport rate
Rate of return to the preinjury sport and level of participation
Time frame: At 1 year
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.
Time frame: Every two weeks to 1-year follow-up; every month from 1 to 2 years follow-up
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.
Time frame: 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
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
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.
Time frame: Before surgery, 1 year, 2 years
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?
Time frame: 3 months, 6 months, 9 months
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.
Time frame: 1 year, 2 years
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.
Time frame: Before surgery, 6 months, 1 year, 2 years
Thigh muscle strength
We will use an isokinetic dynamometer to measure quadriceps and hamstrings concentric and eccentric peak torque.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: Every 2 weeks that the person is completing rehabilitation
Adherence to smartphone intervention
We will count page views for different types of content (including Vimeo for video content, Soundcloud for audio content).
Time frame: At 6 months
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.
Time frame: Before surgery
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