Better and Safer Return to Sport (BEAST)
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|ClinicalTrials.gov Identifier: NCT04049292|
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injuries Sport Injury||Other: Better and safer return to sport (BEAST) Other: Usual care||Not Applicable|
Fewer than half of athletes with ACLR return to competitive sports, and, for those who return, 1 in 5 sustain reinjury. Insufficient functional recovery and poor psychological readiness to RTS are thought to contribute to these low RTS rates and high reinjury rates. Previous research has shown that return to sport (RTS) should be delayed until the athlete passes the criteria of a clinical decision-making tool for RTS. However, to successfully improve RTS and reinjury outcomes, it is imperative that a decision-making tool (1) guides RTS decisions at a specific point in time, and (2) directs the planning and execution of treatments that eventually enable the athlete to safely RTS.
Nonprofessional athletes are often discharged from rehabilitation prior to RTS, and most are treated by rehabilitation clinicians who do not have access to the sophisticated and expensive test equipment used in previous research on functional readiness for RTS. The RTS and rehabilitation tool is therefore designed in collaboration with athletes, coaches and primary care physical therapists as a low-cost intervention that is feasible to implement on a broad scale.
The athletes who follow the RTS and rehabilitation tool will be recruited from Oslo, Norway, while the control group that receives usual care will be recruited from multiple sites in Sweden.
Predefined adjustment factors for the comparative analyses are: age, sex, specific preinjury sport, family history of ACL injury, time from injury to surgery, meniscal and cartilage injury/surgery at ACLR, and ACL graft type. The analysis of reinjury will be adjusted for sports exposure.
- To compare 1 and 2-year sports participation, psychological readiness to RTS, knee function and reinjury outcomes between athletes with ACLR who follow a treatment algorithm with a RTS and rehabilitation tool and those who follow usual care
- To assess adherence and barriers to adherence in athletes with ACLR who follow a treatment algorithm with a RTS and rehabilitation tool
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction|
|Actual Study Start Date :||March 27, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||October 30, 2022|
Experimental: RTS and rehabilitation tool
Six months after ACLR, athletes will commence a standardized RTS assessment. The athlete will follow a standardized, sport-specific progression protocol designed to increase athletic confidence and trust in the knee during sports. Readiness to return to full, unrestricted practice will be determined based on 7 time-based, load-based, clinical and functional criteria. If the athlete fails any of the criteria, he or she will continue to participate in restricted practice. Depending on which of the specific criteria the athlete fails, a targeted treatment plan will be developed. Standardized protocols for effusion management, knee control and strength training will be triggered if the athlete fails the criteria for knee joint effusion, hopping and muscle strength, respectively. The RTS assessment and development of the targeted treatment plan will be repeated every 2 months until the athlete is cleared to RTS, up to a maximum of 12 months after ACLR.
Other: Better and safer return to sport (BEAST)
The RTS assessment includes a Lachman test, modified stroke test, side hop test, triple hop test, and quadriceps muscle power test. The sport-specific progression plans have 6 participation levels in practice and 6 participation levels in match play. A minimum of 2 weeks and 4 training sessions without pain or effusion must be completed before the athlete progresses to the next level. Criteria for full, unrestricted participation in practice: (1)at least 9 months from ACLR, (2)modified stroke test grade 0, (3)completed previous levels in the sport-specific progression plan, (4)negative Lachman test, (5)side hop test limb symmetry at least 90%, (6)triple hop test limb symmetry at least 90%, (7)quadriceps power symmetry at least 90%. The strength training and knee control exercise protocols each have 3-4 different exercises of 3-4 sets that are performed 3 days per week.
Active Comparator: Usual care
Athletes will receive usual care as determined by their treating health care professional
Other: Usual care
Usual care is determined by the treating health care professional
- Return to sport [ Time Frame: 2 years after ACLR ]Participation in preinjury sport (yes/no)
- Reinjury [ Time Frame: 2 years after ACLR ]Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)
- International knee documentation committee subjective knee form [ Time Frame: 2 years after ACLR ]Patient-reported measure of knee symptoms, function and activity level, scored 0-100
- Anterior cruciate ligament return to sport after injury [ Time Frame: 2 years after ACLR ]Patient-reported measure of emotions, confidence in performance, and risk appraisal in relation to RTS, scored 0-100
- Adherence/fidelity to the intervention [ Time Frame: Monthly self-report 7-14 months after ACLR ]Project-specific questionnaire
- Barriers and motivating factors for adherence to the intervention [ Time Frame: 14 months after ACLR ]Self-reported on a project-specific questionnaire
- Sports participation [ Time Frame: 2 years after ACLR ]Self-reported participation in all sports/physical activity
- OSTRC overuse injury questionnaire [ Time Frame: 2 years after ACLR ]Oslo Sport Trauma Research Center overuse injury questionnaire
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): NCT04049292
|Contact: Tone Øritslandemail@example.com|
|Norsk Idrettsmedisinsk Institutt||Recruiting|
|Oslo, Norway, 0806|
|Contact: Hege Grindem, PT PhD firstname.lastname@example.org|
|Principal Investigator: Hege Grindem, PT PhD|
|Contact: Håvard Moksnes, PT PhD email@example.com|
|Sub-Investigator: Håvard Moksnes, PT PhD|
|Principal Investigator:||Hege Grindem, PT PhD||Norwegian School of Sport Sciences|