Better and Safer Return to Sport

NCT ID: NCT04049292

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2024-05-31

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.

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 the Swedish Knee Ligament register (SPARX study Dnr 2019-04546).

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 at ACLR, meniscal repair, 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

Conditions

Anterior Cruciate Ligament Injuries; Sport Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Better and safer return to sport (BEAST)

Intervention Type: OTHER

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.

Usual care

Athletes will receive usual care as determined by their treating health care professional

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Usual care is determined by the treating health care professional

Interventions

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.

Intervention Type: OTHER

Usual care

Usual care is determined by the treating health care professional

Intervention Type: OTHER

Eligibility 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
• contralateral ACL tear
• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role: collaborator

International Olympic Committee

UNKNOWN

Sponsor Role: collaborator

Swedish Research Council for Sport Science

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Norwegian School of Sport Sciences

OTHER

Sponsor Role: lead

Responsible Party

Hege Grindem

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hege Grindem, PT PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian School of Sport Sciences

Locations

Norsk Idrettsmedisinsk Institutt

Oslo, , Norway

Site Status: RECRUITING

Idrettens helsesenter

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Tone Øritsland

Role: CONTACT

t.h.oritsland@nih.no

+4723262367

Facility Contacts

Hege Grindem, PT PhD

Role: primary

hege.grindem@nimi.no

Håvard Moksnes, PT PhD

Role: primary

havard.moksnes@idrettshelse.no

Other Identifiers

2018/1886

Identifier Type: -

Identifier Source: org_study_id