The preventive effect of a football-specific ankle brace on acute lateral ankle sprains in girls amateur football players

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1 The preventive effect of a football-specific ankle brace on acute lateral ankle sprains in girls amateur football players Karin Thijs, Saskia Werner, Bionka Huisstede, Edwin Goedhart, Frank Backx Symposium Sportblessurepreventie november 2017

2 Content 1. Background Study Protocol Preliminary Results Discussion 4.

3 Conflict of Interest Disclosure Main funder: Co-funder: Providing Kicx ankle braces Additional funding to match the subsidy requirements No role in study design, data collection, analyses, decision to publish or preparation of the manuscripts

4 Acute lateral ankle sprains in female football Incidence 1.7/1000 hours of football 4 acute ankle sprains per team per season Especially girls aged are at risk High recurrence rate and frequent pain and/or functional limitations over time Emery et al., 2005; Van Rijn et al., 2008; Clausen et al., 2014; Kemler et al., 2016

Prevention of ankle sprains Compliance is the key

Bracing superior to neuromuscular training for

braces in football, compared to other team sports

5 Prevention of ankle sprains Compliance is the key component to success in preventive strategies Bracing superior to neuromuscular training for (secondary) prevention* Limited usage of ankle braces in football, compared to other team sports Consument en Veiligheid, 2005; TNO Rapport, 2007; *Janssen et al., 2015

Bracing Ankles in Girls Soccer What is the effect of the football-specific ankle brace (Push Sports Kicx) on the incidence and severity of primary and recurrent acute ankle injuries in population of

6 Bracing Ankles in Girls Soccer What is the effect of the football-specific ankle brace (Push Sports Kicx) on the incidence and severity of primary and recurrent acute ankle injuries in population of female amateur football players, aged years? Hypothesis: A football-specific ankle brace will reduce the incidence of acute ankle sprains among young female amateur football players by 50%. Push Sports Kicx, NEA International BV

7 Study design (1/2) Aug. 12 Oct Sept. 12 Oct Oct. 13 th 2016 Nov. 2016! Intervention group (Kicx ankle braces) Enrolment Via KNVB U19 / U17 teams Western district of the Netherlands Baseline measurements Player characteristics Length, weight Beighton score Single leg balance test FAAM-(sport) questionnaire Cluster randomisation Amateur football clubs as unit of cluster Control group (Practice as usual) See next slide Sept Start of football season Thijs et al. The preventive effect of a soccer-specific ankle brace on acute lateral ankle sprains in girls amateur soccer players: study protocol of a cluster-randomised controlled trial. Injury Prevention. July 2017.

Study design (2/2) Nov. 2016 June 2017 July 2017 April 2018 Dec.

8 Study design (2/2) Nov June 2017 July 2017 April 2018 Dec. 23 th 2017 Intervention group (Kicx ankle braces) Control group (Practice as usual) Weekly data collection (SMS/ ) Data collection in case of an ankle sprain Analysis Follow-up Ankle injury recording Individual exposure to football General injury recording Compliance ankle brace for intervention group Standardized telephonic intake interview Physical examination Standardized telephonic recovery interview Intention-to-treat Per-protocol analyse Retrospective registration of acute ankle injuries as from Sept Follow-up intervention Thijs et al., 2017

9 Study population 1. Enrolment Football Clubs assessed for eligibility (n=66) Football clubs declined to participate (n=36) Intervention Group 30 Football clubs randomised (n=30/ 716 players) N=716 Control Group Allocated to intervention (n=15/ 382players) 7 players excluded based on their age Received allocated intervention (n=375) N= Allocation N=324 Allocated to control group (n=15/ 334players) 10 players excluded based on their age Control group (n=324) 3. Follow-up Lost to follow-up (n=43), 11,5% Lost to follow-up (n=43), 13,3% Analysed (n=332) N= Analysis N=281 Analysed (n=281) N=613

10 Study population teams involved 1. Purmerland 2. Sporting DOVO 4. Desto 5. SCH De Meern 7. ADO OSV 9. Zuidvogels 10. Zwanenburg 11. Saestum 12. TOS Actief 13. HBC Heemstede 14. Roda Vreeswijk Teams involved 16. DSS 17. Soest 18. Maarssen 19. Kampong 20. Geuzenmiddenmeer 21. Hercules 22. Fortuna Wormerveer 23. Castricum 24. RKAV Volendam 25. Vriendenschaar 26. Jonathan 27. Focus HFC 29. Roda EVC

11 Study population Characteristics of Study population Intervention group Control group Age, yrs (range) 16.3 ( ) 16.2 ( ) Length, cm ± SD ± ± 6.5 Weight, kg ± SD 63.0 ± ± 9.1 Body Mass Index, kg/m 2 ± SD 22.5 ± ± 2.8 History with ankle injury*, % Hypermobility (Beighton > 4), % Football exposure, hrs ± SD 70.4 ± ± 21.0 * n=545 N=332 N=281

12 Primary outcome measures Incidence of acute lateral ankle sprains (primary and recurrent) Intervention group N=332 N=281 Control group Number of injuries Football exposure, hrs ± SD 70.4 ± ± 21.0 Incidence 1.41/ 1000 hrs 2.06/ 1000 hrs p=0.185 Incidence of recurrent acute lateral ankle sprains N=332 N=281 Intervention group Control group Incidence 2.75/ 1000 hrs 3.75/ 1000 hrs p=0.495

13 Injury incidence per 1000 hours of football Injury incidence Intervention Group Control Group 1 0 Incidence, first-time and recurrent ankle sprains Incidence, corrected for compliance p=0.185 p=0.495 p=0.05

14 Injury severity Injury severity* Intervention group N=332 N=281 Control group Mean, days (range) 21.5 (1-148) 22.4 (1-130) Slight = 1-3 days 11 (4) 6 Minor = 4-7 days 8 (1) 3 Moderate = 8-28 days 8 (2) 15 Major > 28 days 6 (2) 9 Total 33 (9 # ) 33 p=0.091 #9/33 injuries occured while wearing the Kicx ankle brace as prescribed * Definition of severity is the numbers of days between injury date and date of return to play not counting the day on which the injury occured (Fuller et al, 2006)

24 12 Intervention Group Control Group Total 0 Days

15 Injury burden = time-loss per 1000 hrs of football No. of days absent from football Severity & Incidence Intervention Group Control Group Total 0 Days absent from play / 1000 hrs football p=0.839 Bahr et al., 2017

16 Compliance Mean compliance = 53.9%, range 0-100% Percentage of players Primary Prevention Secondary Prevention Total % compliant 30% compliant 50% compliant 70% compliant 90% compliant Percentage compliant

Secondary outcome measures The value of generalized joint hypermobility, as measured with the Beighton score, in predicting the risk of acute lateral ankle sprains The value of the active (muscular)

17 Secondary outcome measures The value of generalized joint hypermobility, as measured with the Beighton score, in predicting the risk of acute lateral ankle sprains The value of the active (muscular) stability, in predicting the risk of acute lateral ankle sprains Influence of ankle braces on active (muscular) activity ( Does it weaken the ankle? ) Centre of pressure Time-to-stability Dynstable, MOTEK

Discussion (1/2) Compliance plays a crucial role in the results of the study Strengths Large study population First study examining the preventive effect of a football-specific ankle

18 Discussion (1/2) Compliance plays a crucial role in the results of the study Strengths Large study population First study examining the preventive effect of a football-specific ankle brace on acute ankle sprains in female players Limitations Study population (age, level of competition) Motivation for primary prevention Registration method (frequency, failure systems)

19 Discussion (2/2) Still preliminary results, next steps are Correlation with hypermobility Correlation with active (muscular) stability/ balance Evaluation of intervention: - elements for compliance - motivation for prevention strategies - possible discomfort/ perceived loss of performance of ankle braces Future Tailored prescription based on player preference/ injury risk

20 Thank you for the attention

Effectiveness of an injury prevention programme for adult male amateur soccer players: a cluster-randomised controlled trial

Effectiveness of an injury prevention programme for adult male amateur soccer players: a cluster-randomised controlled trial BJSM Online First, published on August 9, 2012 as 10.1136/bjsports-2012-091277 Original article 1 Department of Rehabilitation, Nursing Science and Sports, University Medical Centre Utrecht, Utrecht, The