Individualized orthotic alignment and footwear for balance and mobility in children with bilateral spastic cerebral palsy: A randomized trial.

AIM: To examine whether designed-to-be-rigid ankle-foot orthoses and footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD) would be more effective than designed-to-be-rigid AFO with non-individualized alignment and footwear designs (AFO-FC/NAFD) in children with cerebral palsy (CP). METHOD: Nineteen children with bilateral spastic CP were randomized to AFO-FC/NAFD (n = 10) or AFO-FC/IAFD (n = 9) groups. Fifteen were male, average age 6 years 11 months (range 4 years 2 months-9 years 11 months), classified in Gross Motor Function Classification System levels II (n = 15) and III (n = 4). The Pediatric Balance Scale (PBS), Gait Outcomes Assessment List (GOAL), Patient-Reported Outcomes Measurement Information System (PROMIS), and Orthotic and Prosthetic Users' Survey (OPUS) measures of satisfaction were collected at baseline and after 3 months' wear. RESULTS: Compared with the AFO-FC/NAFD group, those with AFO-FC/IAFD demonstrated greater change in PBS total scores (mean 12.8 [standard deviation 10.5] vs 3.5 [5.8]; p = 0.03) and GOAL total scores (3.5 [5.8] vs -0.44 [5.5]; p = 0.03). There were no significant changes in OPUS or PROMIS scores. INTERPRETATION: After 3 months, individualized orthosis alignment and footwear designs had a greater positive effect on balance and parent-reported mobility than a non-individualized approach. No effect was documented for the PROMIS and OPUS. Results may inform orthotic management for ambulatory children with bilateral spastic CP. WHAT THIS PAPER ADDS: Balance and parent-reported mobility increased more over time for the ankle-foot orthoses and footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD) group. Changes in balance over time suggest a therapeutic effect of the AFO-FC/IAFD approach.

Comparison of Sagittal Plane Stiffness of Nonarticulated Pediatric Ankle-Foot Orthoses Designed to be Rigid.

INTRODUCTION: When studying the effect of ankle-foot orthoses (AFOs) on gait, it is important to know their sagittal plane stiffness. However, there are no established thresholds for stiffness of non-articulated AFOs designed to be rigid. If wanting to implement published algorithms for ankle-foot orthosis-footwear combinations (AFO-FCs), the AFOs must be equally as stiff as those of the developer of the published AFO-FC algorithms. Hence, the aim of this work was to compare the sagittal plane stiffness of AFOs designed to be rigid, made for a clinical trial in the USA, and following algorithms for AFO-FC designs, to those made and used clinically in the UK by the developer of the AFO-FC algorithms. MATERIALS AND METHODS: Stiffness of 9 pediatric polypropylene AFOs was tested (UK: 6; USA: 3). A computer-controlled motorized device was used in which all AFOs were clamped with the calf shell in a fixed vertical component and the foot section in a rotating plate. Each AFO was tested for 3 trials, loading the foot plate 30 Nm towards dorsiflexion and 20 Nm towards plantarflexion. Torque-angle graphs were plotted and deflection and stiffness compared descriptively across AFOs. RESULTS: Average deflection of AFOs was UK: 3.42±0.83° and USA: 4.81±1.05°. Average stiffness of AFOs was UK: 14.34±3.34 Nm/° and USA: 10.30±1.92 Nm/°. CONCLUSIONS: All tested AFOs deflected only a few degrees in either direction (range: 2.59° to 6.02°), providing the first information reported for the stiffness of rigid pediatric non-articulated AFOs. Overall, the UK AFOs were stiffer and deflected less than the USA study AFOs. AFO design features should be carefully considered as they likely influence sagittal plane stiffness and deflection under load.