Page 33 - Maximizing the efficacy of ankle foot orthoses in children with cerebral palsy

The AFO-CP protocol
1. To study the effect of an FRO optimised for ankle stiffness on walking energy cost
in children with SCP walking with excessive knee flexion, compared to walking with shoes alone.
2. To identify the possible working mechanisms of an FRO, and the predictors for suc- cess of FRO treatment in children with spastic CP, walking with excessive knee flexion.
MethodS Design
II
A pre-post experimental study consisting of two repeated measurements, i.e. at baseline, T0, walking with shoes only (control) and at 12-20 weeks follow-up, T2, walking with an optimised FRO (case) will be performed to evaluate FRO efficacy in children with spastic CP (see Figure 2.1). The study protocol has been approved by the Medical Ethics Committee of the VU University medical center in Amsterdam.
Following completion of study enrolment, baseline measurements (T0) will be per- formed barefoot, with shoes only and with the subject’s current orthoses (if applicable). Stiffness (K) of the new FRO will be varied into three configurations: rigid, stiff, and flex- ible. A balanced block randomisation will be applied for six possible sequences of stiff- ness configurations, to ensure that the same number of patients is allocated to each se- quence. Every configuration will be worn for an accommodation period of four to eight weeks, after which FRO efficacy will be evaluated (T1K1,T1K2 and T1K3). An analysis of the evaluation of all FRO configurations will allow the selection of the stiffness with the maximal benefit for a particular subject, referred to as the subject’s optimal FRO (the selection procedure is explained further below). Following this selection, the optimal FRO will be worn for twelve to twenty weeks, after which the follow-up measurements (T2) will be taken.
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