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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((R)) 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 - 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.
CI - (c) The Author(s) 2014.

Langue : ANGLAIS

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