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Day versus day-night use of ankle-foot orthoses in young children with spastic diplegia: a randomized controlled study
Zhao X, Xiao N, Li H, Du S
American Journal of Physical Medicine & Rehabilitation 2013 Oct;92(10):905-911
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: The aim of this study was to compare the effectiveness of treatment with hinged ankle-foot orthoses (AFOs) during the day versus 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 weeks. 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.

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