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

Abstract

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 decrease of ankle-foot dorsiflexion range of motion between the experimental and control groups (difference: -1.05°, 95% confidence interval: -4.71° - 2.61°). 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.

• Authors: Jc Maas, Aj Dallmeijer, Pa Huijing, Je Brunstrom-Hernandez, Pj van Kampen, Eam Bolster, C Dunn, K Herndon, Rt Jaspers, Jg Becher
• Journal: Clinical rehabilitation (Clin Rehabil) Vol. 28 Issue 10 Pg. 1025-38 (Oct 2014) ISSN: 1477-0873 [Electronic] England
• PMID: 25082956 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2014.

Topics

• Cerebral Palsy (complications, rehabilitation)
• Child
• Equinus Deformity (etiology, prevention & control)
• Female
• Gait Disorders, Neurologic (etiology, rehabilitation)
• Humans
• Lower Extremity (physiology, physiopathology)
• Male
• Multilevel Analysis
• Netherlands
• Orthotic Devices (adverse effects, statistics & numerical data)
• Range of Motion, Articular (physiology)
• Time Factors
• United States (ethnology)