OBJECTIVE: To examine whether using a knee-ankle-foot orthosis helps maintain ankle-foot dorsiflexion range of motion over time. DESIGN: A multicentre randomized controlled trial. SETTING: Two hospitals and one rehabilitation centre in the Netherlands and the USA. SUBJECTS: Children (4 to 16 years old) with spastic cerebral palsy who were able to walk. INTERVENTION: Use of a knee-ankle-foot orthosis, equipped with an Ultraflex ankle power unit, for at least 6 hours every other night for one year. MAIN MEASURES: Primary outcome measure: ankle-foot dorsiflexion range of motion. Secondary outcome measures: ankle-foot and knee angle in gait and gross motor function. Wearing time was also measured. Measurements were taken at baseline and at 3, 6, 9 and 12 months. RESULTS: 28 children (experimental group n = 15, control group n = 13) participated in the study. 11 participants (experimental n = 4, control n = 7) did not complete all five measurements, as they needed additional treatment. No significant difference was found in the decrease of ankle-foot dorsiflexion range of motion between the experimental and control groups (difference -1.05 degrees, 95% confidence interval -4.71 degrees to 2.61 degrees). In addition, secondary outcome measures did not show differences between groups. Despite good motivation, knee-ankle-foot orthosis wearing time was limited to a mean +/- SD of 3.2 +/- 1.9 hours per prescribed night due to discomfort. CONCLUSIONS: Knee-ankle-foot orthosis with dynamic ankle and fixed knee are poorly tolerated and are not beneficial in preventing a reduction in ankle-foot dorsiflexion range of motion in children with spastic cerebral palsy, at least with limited use.

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