The Lower-Extremity Orthosis (LEO) study (Evans, Gowland, et al.J is a randomized controlled trial assessing the efficacy of ankle-foot orthoses (AFOs) in treating preambulatory children with spastic diplegic cerebral palsy. The range of neuromuscular and skeletal presentations manifested by the cerebral palsy child created a challenge when attempting to standardize the orthotic prescription criteria and orthotic design for the study. The study was more difficult because of the differing approaches to cerebral palsy management and the variety of orthosis designs available. Consensus techniques were used to develop the standardized orthotic management protocol for the LEO study. Consensus methods have been used to define levels of agreement on controversial medical problems (1-3). A combination of the Delphi and Nominal Groups consensus methods was used to develop the orthotic management protocol for the LEO study. Current orthotic management techniques were collected through a survey sent to orthotists and therapists (CP Orthotic Management Survey), and this information was used to draft the protocol. Therapists, ortholists and researchers involved in the LEO study revised the draft. This article documents the development method of the orthotic management protocol as applied to orthotic management problems.
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Donald J. Weber (1994) studied this question.
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