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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
Sponsor:
Collaborators:
Norwegian Fund for Postgraduate Training in Physiotherapy
International Olympic Committee
Swedish Research Council for Sport Science
Linkoeping University
Karolinska Institutet
Information provided by (Responsible Party):
Hege Grindem, Norwegian School of Sport Sciences

Brief Summary:
A prospective cohort design will be used to assess differences in outcomes between pivoting sport athletes with anterior cruciate ligament reconstruction (ACLR) who follow usual care and those who follow a treatment algorithm with a RTS and rehabilitation tool. Athletes aged 15-40 at injury with primary ACLR who express a goal to return to sports with frequent pivoting are eligible. The RTS and rehabilitation tool includes standardized clinical, functional and muscle strength testing 6, 8, 10, and 12 months after surgery. Individual test results guide progression in sports participation and the content of further rehabilitation according to a standardized algorithm.

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

Detailed Description:

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.

Objectives

  • 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Return to sport [ Time Frame: 2 years after ACLR ]
    Participation in preinjury sport (yes/no)

  2. Reinjury [ Time Frame: 2 years after ACLR ]
    Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Adherence/fidelity to the intervention [ Time Frame: Monthly self-report 7-14 months after ACLR ]
    Project-specific questionnaire

  4. Barriers and motivating factors for adherence to the intervention [ Time Frame: 14 months after ACLR ]
    Self-reported on a project-specific questionnaire


Other Outcome Measures:
  1. Sports participation [ Time Frame: 2 years after ACLR ]
    Self-reported participation in all sports/physical activity

  2. OSTRC overuse injury questionnaire [ Time Frame: 2 years after ACLR ]
    Oslo Sport Trauma Research Center overuse injury questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary anterior cruciate ligament reconstruction 6 months ago (+- 2 weeks)
  • age 15-40 years at the time of anterior cruciate ligament injury
  • preinjury participation in level I pivoting sport at least 2 times per week
  • expressed goal to return to level I sport

Exclusion Criteria:

  • grade 3 injury to the medial collateral ligament, lateral collateral ligament, or posterior cruciate ligament
  • inability to understand the native language in the country of recruitment
  • other serious injury or illness that impairs function
  • has access to specialist sports medicine care (e.g., health support from national team) not accessible to all athletes
  • derives primary income from sports participation
  • member of sports health team present at the majority of the team's training sessions

Information from the National Library of Medicine

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


Contacts
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Contact: Tone Øritsland +4723262367 t.h.oritsland@nih.no

Locations
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Norway
Norsk Idrettsmedisinsk Institutt Recruiting
Oslo, Norway, 0806
Contact: Hege Grindem, PT PhD       hege.grindem@nimi.no   
Principal Investigator: Hege Grindem, PT PhD         
Idrettens helsesenter Recruiting
Oslo, Norway
Contact: Håvard Moksnes, PT PhD       havard.moksnes@idrettshelse.no   
Sub-Investigator: Håvard Moksnes, PT PhD         
Sponsors and Collaborators
Norwegian School of Sport Sciences
Norwegian Fund for Postgraduate Training in Physiotherapy
International Olympic Committee
Swedish Research Council for Sport Science
Linkoeping University
Karolinska Institutet
Investigators
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Principal Investigator: Hege Grindem, PT PhD Norwegian School of Sport Sciences

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Responsible Party: Hege Grindem, Senior researcher, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT04049292     History of Changes
Other Study ID Numbers: 2018/1886
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hege Grindem, Norwegian School of Sport Sciences:
anterior cruciate ligament
return to sport
anterior cruciate ligament reconstruction
rehabilitation

Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Athletic Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries