|- candidate number||25266|
|- NTR Number||NTR6045|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-sep-2016|
|- Secondary IDs||METC protocol number 16/298|
|- Public Title||The preventive effect of an ankle brace, especially designed for soccer players, on acute ankle injuries in girls amateur soccer players.|
|- Scientific Title||The preventive effect of an ankle brace on acute ankle injuries in girls amateur soccer players: a cluster-randomized controlled trial.|
|- ACRONYM||Bracing Ankles in Girls Soccer (BAGS)|
|- hypothesis||We hypothesize that a semi-rigid ankle brace especially designed for soccer players, wil reduce the incidence of ankle sprain injuries among amateur girls soccer players by 50%.|
|- Healt Condition(s) or Problem(s) studied||Ankle, Injuries, Sports|
|- Inclusion criteria||The study will comprise soccer clubs from one geographically district affiliated with the KNVB (i.e. the Royal Netherlands Football Association). Clubs are eligible if they have at least one girls team participating in the U19 or U17 competition.
Players are eligible if they are aged 14 - 18 years.|
|- Exclusion criteria||Players will be excluded if they do not master the Dutch language.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-sep-2016|
|- planned closingdate||29-mei-2017|
|- Target number of participants||704|
|- Interventions||The intervention in this study is the Push Sports Kicx ankle brace, a semi-rigid ankle brace especially designed for soccer players. This brace will be used on both sides during all soccer-related activities (training and match).|
|- Primary outcome||Injury incidence (injuries per 1000 playing hours) and injury severity (soccer-absenteeism).|
|- Secondary outcome||- Brace effectivity in primary and secondary prevention of acute ankle injuries.|
- Prognostic value of generalized joint hypermobility on the risk of acute ankle injuries.
- Prognostic value of active (ankle)stability on the risk of acute ankle injuries.
- The effect of the PSB Sports Kick ankle brace on ankle-related functional limitation, experiences by the players during sport activities (e.g. running, jumping, turning).
- Compliance of the intervention group, wearing PSB Sports ankle braces
|- Timepoints||Weekly registration starts 05-09-2016|
Intervention starts 31-10-2016
Follow-up ends 29-05-2017
Baseline measurements (e.g. length, weight, single leg balance tests, Beighton score) and questionnaires (e.g. player characteristics and injury history) will be performed < 31-10-2016.
Weekly registration by SMS or e-mail, containing questions about ankle complaints, exposure hours, other injuries, compliance to intervention.
In case of ankle injury: information regarding diagnosis, etiology, injury date, contact vs non-contact, recovery date, medical treatment, absenteeism from school-/ work).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. K.M. Thijs|
|- CONTACT for SCIENTIFIC QUERIES||Drs. K.M. Thijs|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), department of Rehabilitation, Nursing Science & Sports|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, NEA International BV |
|- Brief summary||An ankle sprain, mainly of the inversion type, is one of the most common injuries in soccer and often results in time-loss from play. This disabling injury can cause residual complaints such as instability, chronic ankle pain and functional limitation over time and has a high proportion of recurrences. |
A number of measures reduce the incidence of ankle sprains in soccer players. These include neuromuscular (proprioceptive and coordination) training and/ or the use of an external support to decrease inversion and eversion range of movement of the ankle joint (like taping or a semi-rigid braces). The key element in the success of a preventive measure is compliance. We know that this element is higher for the use of ankle braces than the performance of neuromuscular training. Dutch soccer players do not often wear braces during their sport. A national survey in 2007 among Dutch soccer players reported that this is the result of a supposed lack of good fit of the available braces and pinching of the feet in the soccer shoes due to the thickness of the braces and the fear of reduced ball control. Using an ankle brace specifically developed for and in cooperation with soccer players to prevent (recurrent) ankle sprains (PSB Sports Kicx), may very likely contribute to the removal of the above-suggested barriers to wear braces during soccer play. We hypothesize that this brace will reduce the incidence of ankle sprain injuries among amateur girls’ soccer players by 50%.
|- Main changes (audit trail)|
|- RECORD||8-sep-2016 - 3-nov-2016|