Objective: The aim of this study was to compare the effectiveness of treatment with hinged ankle-foot orthoses (AFOs) during the day vs. during both the day and the night in young ambulant children with spastic diplegia.
Design: In this prospective randomized controlled trial, 112 ambulatory children (70 boys and 42 girls; mean age, 2 yrs 6.93 mos; range, 1 yr 1 mo to 4 yrs 0 mo) with spastic diplegia participated. Forty-eight were classified at level I of the Gross Motor Function Classification System; the remaining 64 were at level II. Using stratified randomization, all children were assigned to either the day AFO-wearing group (n = 56, wearing AFOs all day) or the day-night AFO-wearing group (n = 56, wearing AFOs all day and all night). The two groups underwent conventional rehabilitative treatments five times a week for 8 wks. The primary outcomes measured were passive ankle dorsiflexion angle and sections D and E of the 66-item Gross Motor Function Measure; the root mean square of surface electromyography in the ventral and dorsal lower limb muscles was compared in a subgroup (ten from each group).
Results: Seven children did not complete the full intervention: three in the day AFO-wearing group and four in the day-night AFO-wearing group. Significant baseline-postintervention improvements were found for passive ankle dorsiflexion angle and the 66-item Gross Motor Function Measure in both groups (P < 0.05). On the basis of the score changes, there was no significant difference between these two groups with respect to passive ankle dorsiflexion angle; however, the improvements in the 66-item Gross Motor Function Measure were significantly better in the day AFO-wearing group (P < 0.01). A significant root mean square decrease in gastrocnemius (P < 0.05) was present after the intervention in the day AFO-wearing group, whereas the muscles affected in the day-night AFO-wearing group were the gastrocnemius (P < 0.05) and the tibialis anterior (P < 0.001).
Conclusions: The results demonstrate that the daytime use of AFOs was more effective in improving Gross Motor Function Measure scores than the day-night use. In addition, the prolonged wearing of AFOs may influence muscle activity, which should be monitored in the clinic.