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Better and Safer Return to Sport (BEAST)

Primary Purpose

Anterior Cruciate Ligament Injuries, Sport Injury

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Better and safer return to sport (BEAST)
Usual care
Sponsored by
Norwegian School of Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring anterior cruciate ligament, return to sport, anterior cruciate ligament reconstruction, rehabilitation

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norsk Idrettsmedisinsk InstituttRecruiting
  • Idrettens helsesenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RTS and rehabilitation tool

Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Return to sport
Participation in preinjury sport (yes/no)
Reinjury
Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)

Secondary Outcome Measures

International knee documentation committee subjective knee form
Patient-reported measure of knee symptoms, function and activity level, scored 0-100
Anterior cruciate ligament return to sport after injury
Patient-reported measure of emotions, confidence in performance, and risk appraisal in relation to RTS, scored 0-100
Adherence/fidelity to the intervention
Project-specific questionnaire
Barriers and motivating factors for adherence to the intervention
Self-reported on a project-specific questionnaire

Full Information

First Posted
August 2, 2019
Last Updated
March 21, 2023
Sponsor
Norwegian School of Sport Sciences
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy, International Olympic Committee, Swedish Research Council for Sport Science, Linkoeping University, Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04049292
Brief Title
Better and Safer Return to Sport
Acronym
BEAST
Official Title
Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian School of Sport Sciences
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy, International Olympic Committee, Swedish Research Council for Sport Science, Linkoeping University, Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Sport Injury
Keywords
anterior cruciate ligament, return to sport, anterior cruciate ligament reconstruction, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RTS and rehabilitation tool
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Athletes will receive usual care as determined by their treating health care professional
Intervention Type
Other
Intervention Name(s)
Better and safer return to sport (BEAST)
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Usual care is determined by the treating health care professional
Primary Outcome Measure Information:
Title
Return to sport
Description
Participation in preinjury sport (yes/no)
Time Frame
2 years after ACLR
Title
Reinjury
Description
Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)
Time Frame
2 years after ACLR
Secondary Outcome Measure Information:
Title
International knee documentation committee subjective knee form
Description
Patient-reported measure of knee symptoms, function and activity level, scored 0-100
Time Frame
2 years after ACLR
Title
Anterior cruciate ligament return to sport after injury
Description
Patient-reported measure of emotions, confidence in performance, and risk appraisal in relation to RTS, scored 0-100
Time Frame
2 years after ACLR
Title
Adherence/fidelity to the intervention
Description
Project-specific questionnaire
Time Frame
Monthly self-report 7-14 months after ACLR
Title
Barriers and motivating factors for adherence to the intervention
Description
Self-reported on a project-specific questionnaire
Time Frame
14 months after ACLR
Other Pre-specified Outcome Measures:
Title
Sports participation
Description
Self-reported participation in all sports/physical activity
Time Frame
2 years after ACLR
Title
OSTRC overuse injury questionnaire
Description
Oslo Sport Trauma Research Center overuse injury questionnaire
Time Frame
2 years after ACLR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tone Øritsland
Phone
+4723262367
Email
t.h.oritsland@nih.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hege Grindem, PT PhD
Organizational Affiliation
Norwegian School of Sport Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norsk Idrettsmedisinsk Institutt
City
Oslo
ZIP/Postal Code
0806
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hege Grindem, PT PhD
Email
hege.grindem@nimi.no
First Name & Middle Initial & Last Name & Degree
Hege Grindem, PT PhD
Facility Name
Idrettens helsesenter
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Håvard Moksnes, PT PhD
Email
havard.moksnes@idrettshelse.no
First Name & Middle Initial & Last Name & Degree
Håvard Moksnes, PT PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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