|- candidate number||6530|
|- NTR Number||NTR2031|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-sep-2009|
|- Secondary IDs||WC2009-041 Wetenschapscommissie EMGO+ Instituut|
|- Public Title||Prevention of fall related sports and physical activity injuries in youth.|
|- Scientific Title||Evaluation of a school based fall related injury prevention training program.|
|- hypothesis||Reduction of number of fall related injuries in school children.|
|- Healt Condition(s) or Problem(s) studied||Fall injuries, Children|
|- Inclusion criteria||1. School children (group 5,6,7,8 of Dutch primary schools);|
2. Knowledge of the Dutch language;
3. Skilled in reading and writing.
|- Exclusion criteria||Participants have to be mentally and physically capable of completing the training program.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||10-jan-2009|
|- planned closingdate||7-jul-2010|
|- Target number of participants||3600|
|- Interventions||The intervention group will receive an eight week during fall-related injury prevention training program (titled: ‘Vallen is ook een sport’ © 2009 Consument en Veiligheid). The main purpose of this training is to teach children how to fall safely. This training course can be integrated in primary school gymnastic lessons and will be given by the children’s regular gymnastic teacher.|
The (gymnastic) teachers of the control group will execute their normal routine.
|- Primary outcome||Primary outcomes are incidence and severity of fall-related injuries. These outcomes will be monitored during the school year by the (gymnastic) teachers. Every week, the children will be asked about their injuries. When a child has suffered a severe injury (according to the definition of van Mechelen et al.), he or she fills in a form that questions the injury. The severity of the injury will be based on the time-loss of participation in physical activity. Because children will only fall if they take part in physical activity, the exposure will be questioned three times during the schoolyear. |
|- Secondary outcome||Two secondary outcomes will be measured in this study:|
1. Evaluation of the promoting and hindering factors for implementation of the program will be evaluated by questioning both children and teachers (process evaluation);
2. The effect of the training program on fall-coordination and fall-skills will be measured on three occasions during the school year with a physical fall-test. The test will only be executed in 10 classes.
|- Timepoints||0M = oct 2009;|
1M = jan 2010;
2M = may/june 2010.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Evert Verhagen|
|- CONTACT for SCIENTIFIC QUERIES|| Evert Verhagen|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|Consument en veiligheid|
|- Brief summary||In the Netherlands, an increase has been found in the number of sports related injuries in children. This increase mainly concerned wrist fractures due to fall-injuries in children aged 8-12 years. Because the increase in injuries does not show a relationship with sports participation, it is theorized that the injuries can be influenced by improving falling skills in school children. To improve these falling skills, Consument en Veilligheid has developed a training program in which children will learn how to fall more safely.
The main purpose of this study is to evaluate the effect of the training program on incidence and severity of fall-related injuries in primary school children. Furthermore the possibilities of implementing the training program in the gymnastic course will be evaluated, and fall-skills and fall-coordination will be measured.
|- Main changes (audit trail)|
|- RECORD||28-sep-2009 - 29-okt-2009|