A randomized controlled trial studying efficacy and tolerance of a knee-ankle-foot orthosis used to prevent equinus in children with spastic cerebral palsy

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 (4-16 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 ...