The osteogenic potential of short durations of low-level mechanical stimuli was examined in children with disabling conditions. The mean change in tibia vTBMD was ؉6.3% in the intervention group compared with ؊11.9% in the control group. This pilot randomized controlled trial provides preliminary evidence that low-level mechanical stimuli represent a noninvasive, non-pharmacological treatment of low BMD in children with disabling conditions. Introduction: Recent animal studies have demonstrated the anabolic potential of low-magnitude, high-frequency mechanical stimuli to the trabecular bone of weight-bearing regions of the skeleton. The main aim of this prospective, double-blind, randomized placebo-controlled pilot trial (RCT) was to examine whether these signals could effectively increase tibial and spinal volumetric trabecular BMD (vTBMD; mg/ml) in children with disabling conditions. Materials and Methods: Twenty pre-or postpubertal disabled, ambulant, children (14 males, 6 females; mean age, 9.1 Ϯ 4.3 years; range, 4 -19 years) were randomized to standing on active (n ϭ 10; 0.3g, 90 Hz) or placebo (n ϭ 10) devices for 10 minutes/day, 5 days/week for 6 months. The primary outcomes of the trial were proximal tibial and spinal (L 2 ) vTBMD (mg/ml), measured using 3-D QCT. Posthoc analyses were performed to determine whether the treatment had an effect on diaphyseal cortical bone and muscle parameters. Results and Conclusions: Compliance was 44% (4.4 minutes per day), as determined by mean time on treatment (567.9 minutes) compared with expected time on treatment over the 6 months (1300 minutes). After 6 months, the mean change in proximal tibial vTBMD in children who stood on active devices was 6.27 mg/ml (ϩ6.3%); in children who stood on placebo devices, vTBMD decreased by Ϫ9.45 mg/ml (Ϫ11.9%). Thus, the net benefit of treatment was ϩ15.72 mg/ml (17.7%; p ϭ 0.0033). In the spine, the net benefit of treatment, compared with placebo, was ϩ6.72 mg/ml, (p ϭ 0.14). Diaphyseal bone and muscle parameters did not show a response to treatment. The results of this pilot RCT have shown for the first time that low-magnitude, high-frequency mechanical stimuli are anabolic to trabecular bone in children, possibly by providing a surrogate for suppressed muscular activity in the disabled. Over the course of a longer treatment period, harnessing bone's sensitivity to these stimuli may provide a non-pharmacological treatment for bone fragility in children.
Background: Severely disabled children with cerebral palsy (CP) are prone to low trauma fractures, which are associated with reduced bone mineral density. Aims: To determine whether participation in 50% longer periods of standing (in either upright or semiprone standing frames) would lead to an increase in the vertebral and proximal tibial volumetric trabecular bone mineral density (vTBMD) of non-ambulant children with CP. Methods: A heterogeneous group of 26 pre-pubertal children with CP (14 boys, 12 girls; age 4.3-10.8 years) participated in this randomised controlled trial. Subjects were matched into pairs using baseline vertebral vTBMD standard deviation scores. Children within the pairs were randomly allocated to either intervention (50% increase in the regular standing duration) or control (no increase in the regular standing duration) groups. Pre-and post-trial vertebral and proximal tibial vTBMD was measured by quantitative computed tomography (QCT). Results: The median standing duration was 80.5% (9.5-102%) and 140.6% (108.7-152.2%) of the baseline standing duration in the control group and intervention group respectively. The mean vertebral vTBMD in the intervention group showed an increase of 8.16 mg/cm 3 representing a 6% mean increase in vertebral vTBMD. No change was observed in the mean proximal tibial vTBMD. Conclusion: A longer period of standing in non-ambulant children with CP improves vertebral but not proximal tibial vTBMD. Such an intervention might reduce the risk of vertebral fractures but is unlikely to reduce the risk of lower limb fractures in children with CP.
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