Randomised Controlled Trial of a Therapeutic Playgroup for Children with Developmental Delays.

A single-blind randomised control trial investigated the effectiveness of the Learn, Engage and Play (LEaP) playgroup. Seventy-one children with developmental delay were randomly allocated to an 8-week LEaP playgroup or control group and followed up at 12 and 28 weeks. On the primary outcome measure, LEaP demonstrated significant within group changes at 28 weeks (parenting distress p = 0.018) but no between group changes. On secondary outcome measures, at 12 weeks LEaP produced significantly better outcomes than control in goal achievement (performance p = 0.022; function p = 0.008) and family-support (p = 0.024), with LEaP continuing to demonstrate significantly better goal achievement (child performance p = 0.042; function p = 0.012) at 28 weeks. Findings indicate LEaP may assist in improving family-support and goal achievement outcomes for children with developmental delays.

Direct infant UV light exposure is associated with eczema and immune development.

BACKGROUND: Suboptimal vitamin D levels during critical periods of immune development have emerged as an explanation for higher rates of allergic diseases associated with industrialization and residing at higher latitudes. OBJECTIVE: We sought to determine the effects of early postnatal vitamin D supplementation on infant eczema and immune development. METHODS: By using a double-blind randomized controlled trial, newborn infants were randomized to receive vitamin D supplementation (400 IU/d) or a placebo until 6 months of age. Some infants also wore personal UV dosimeters to measure direct UV light (290-380 nm) exposure. Infant vitamin D levels were measured at 3 and 6 months of age. Eczema, wheeze, and immune function outcomes were assessed at 6 months of age. RESULTS: At 3 (P < .01) and 6 (P = .02) months of age, vitamin D levels were greater for the vitamin D-supplemented group than the placebo group, but there was no difference in eczema incidence between groups. Infants with eczema were found to have had less UV light exposure (median, 555 Joules per square meter [J/m2; interquartile range, 322-1210 J/m2]) compared with those without eczema (median, 998 J/m2 [interquartile range, 676-1577 J/m2]; P = .02). UV light exposure was also inversely correlated with IL-2, GM-CSF, and eotaxin production to Toll-like receptor ligands. CONCLUSION: This study is the first to demonstrate an association between greater direct UV light exposures in early infancy with lower incidence of eczema and proinflammatory immune markers by 6 months of age. Our findings indicate that UV light exposure appears more beneficial than vitamin D supplementation as an allergy prevention strategy in early life.

Neuromuscular electrical stimulation-assisted gait increases muscle strength and volume in children with unilateral spastic cerebral palsy.

AIM: To determine if neuromuscular electrical stimulation (NMES) applied to the ankle dorsiflexors during gait improves muscle volume and strength in children with unilateral spastic cerebral palsy (CP). METHOD: Thirty-two children (15 females, 17 males; mean age 10y 8mo, age range 5y 5mo-18y 1mo) with unilateral spastic CP and a Gross Motor Function Classification System of level I or level II were randomly assigned to either the 8-week daily NMES treatment group or control group (usual or conventional treatments). Outcomes at week 8 (post-NMES) and week 14 (carryover) included magnetic resonance imaging for muscle volumes (tibialis anterior, anterior compartment, and gastrocnemius), strength (hand-held dynamometry for isometric dorsiflexion strength and heel raises for functional strength), and clinical measures for lower limb selective motor control. RESULTS: At week 8, the treatment group demonstrated significantly (p<0.05) increased muscle volumes for tibialis anterior, anterior compartment, medial and lateral gastrocnemius, and dorsiflexion strength not only when compared to their baseline values but also when compared to the control group at week 8. At week 14, both tibialis anterior and lateral gastrocnemius volumes in the treatment group remained significantly increased when compared to their baseline values. However, only lateral gastrocnemius volumes had significantly greater values when compared to the control group at week 14. There were no between group differences in the clinical measures for lower limb selective motor control at week 8 and 14. INTERPRETATION: Eight weeks of daily NMES-assisted gait increases muscle volume and strength of the stimulated ankle dorsiflexors in children with unilateral spastic CP. These changes are use-dependent and do not carry over after the 8-week treatment period. Gastrocnemius volume also increased post-treatment with carryover at week 14.

The orthotic and therapeutic effects following daily community applied functional electrical stimulation in children with unilateral spastic cerebral palsy: a randomised controlled trial.

BACKGROUND: The purpose of this study was to determine the orthotic and therapeutic effects of daily community applied FES to the ankle dorsiflexors in a randomized controlled trial. We hypothesized that children receiving the eight-week FES treatment would demonstrate orthotic and therapeutic effects in gait and spasticity as well as better community mobility and balance skills compared to controls not receiving FES. METHODS: This randomized controlled trial involved 32 children (mean age 10 yrs 3 mo, SD 3 yrs 3 mo; 15 females, 17 males) with unilateral spastic cerebral palsy and a Gross Motor Function Classification System of I or II randomly assigned to a FES treatment group (n = 16) or control group (n = 16). The treatment group received eight weeks of daily FES (four hours per day, six days per week) and the control group received usual orthotic and therapy treatment. Children were assessed at baseline, post FES treatment (eight weeks) and follow-up (six weeks after post FES treatment). Outcome measures included lower limb gait mechanics, clinical measures of gastrocnemius spasticity and community mobility balance skills. RESULTS: Participants used the FES for a mean daily use of 6.2 (SD 3.2) hours over the eight-week intervention period. With FES, the treatment group demonstrated a significant (p < 0.05) increase in initial contact ankle angle (mean difference 11.9° 95% CI 6.8° to 17.1°), maximum dorsiflexion ankle angle in swing (mean difference 8.1° 95% CI 1.8° to 14.4°) normalized time in stance (mean difference 0.27 95% CI 0.05 to 0.49) and normalized step length (mean difference 0.06 95% CI 0.003 to 0.126) post treatment compared to the control group. Without FES, the treatment group significantly increased community mobility balance scores at post treatment (mean difference 8.3 units 95% CI 3.2 to 13.4 units) and at follow-up (mean difference 8.9 units 95% CI 3.8 to 13.9 units) compared to the control group. The treatment group also had significantly reduced gastrocnemius spasticity at post treatment (p = 0.038) and at follow-up (dynamic range of motion mean difference 6.9°, 95% CI 0.4° to 13.6°; p = 0.035) compared to the control group. CONCLUSION: This study documents an orthotic effect with improvement in lower limb mechanics during gait. Therapeutic effects i.e. without FES were observed in clinical measures of gastrocnemius spasticity, community mobility and balance skills in the treatment group at post treatment and follow-up. This study supports the use of FES applied during daily walking activities to improve gait mechanics as well as to address community mobility issues among children with unilateral spastic cerebral palsy. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Register ACTRN12614000949684 . Registered 4 September 2014.

Effects of short-term daily community walk aide use on children with unilateral spastic cerebral palsy.

PURPOSE: To determine the effects of functional electrical stimulation (FES) on the main impairments affecting gait in children with unilateral spastic cerebral palsy. METHODS: A 20-week, multiple single-subject A-B-A design included a 6-week pre-FES phase, an 8-week FES phase, and a 6-week post-FES phase. Twelve children, aged 5 to 16 years, wore an FES device (the Walk Aide) daily for 8 weeks. Weekly measures included ankle range of motion, selective motor control, dorsiflexion and plantar flexion strength, gastrocnemius spasticity, single-limb balance, Observational Gait Scale (OGS) score, and self-reported toe drag and falls in the community. RESULTS: Compared with the pre-FES phase, the FES phase showed significant improvements in ankle range of motion, selective motor control and strength, and reductions in spasticity, toe drag, and falls, but no change in OGS score. These improvements were maintained during the post-FES phase. CONCLUSIONS: Intermittent, short-term use of FES is potentially effective for reducing impairments affecting gait in children with unilateral spastic cerebral palsy.