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

ABSTRACT

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.