Page 43 - Maximizing the efficacy of ankle foot orthoses in children with cerebral palsy
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The AFO-CP protocol
(ANOVA) will be performed to determine which factors are significantly associated with FRO treatment outcomes (p≤0.1). Significant factors (p≤.05) will then be included in a multivariate regression model. Model analysis will include factors such as level of physi- cal fitness, baseline disease characteristics, gait pattern, level of functional mobility, en- vironmental factors and FRO characteristics.
dIScUSSIon
II
This study will evaluate the effects of varying degrees of FRO ankle stiffness on dif- ferent aspects of gait. Based on earlier studies, an optimal match is expected between specific patient characteristics and FRO stiffness. Assuming that there is an optimal FRO stiffness for each subject, this study might lead directly to an optimised FRO treatment for these patients. In addition, the study will evaluate FRO efficacy, using outcome mea- sures that are relevant in the patient’s daily life (i.e. walking energy cost and daily activ- ity), thereby emphasising clinical relevance.
Because the stiffness of an FRO should be based on the specific gait deviations of the child, the inclusion criteria of this study will be specifically defined. This will result in a relatively homogeneous study population, enabling a fair comparison of subjects. On the other hand, these strict criteria may make it difficult to generalise results to the wider treatment and prescription of FROs, also because the design of the investigational FRO design differs from conventional FROs. Nonetheless, it is expected that the results of the study will allow an optimal FRO treatment to be defined in this specific patient group.
This study will be the first to investigate broadly the efficacy of an individually op- timised FRO, including evaluation of effects on multiple ICF levels. This will result in a unique data set with which to assess mutual relations between outcome measures. We anticipate that this analysis will aid in identifying both the underlying working mecha- nisms of FRO and the factors important to treatment success. In conclusion, the data generated by this study may provide not only novel insights, but may also contribute to improved FRO treatment in spastic CP in the (near) term.
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