GRIN: " GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: An assessor-masked randomised comparison trial": Study protocol

Background: Cerebral palsy is the most common cause of physical disability in childhood. Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation. The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered (one on one) physiotherapy rehabilitation. With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework, it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes, encouraging providers to offer flexible models of physiotherapy delivery. This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years.Methods/Design: An assessor-masked, block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy. A sample size of 30 (15 in each study arm) will be recruited. Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities (three exercises to be performed three times a week). Study groups will be compared at baseline (T1), then at 10 weeks (T2, efficacy) and 26 weeks (T3, retention) post Botulinum Toxin-A injections. Primary outcomes will be caregiver/s perception of and satisfaction with their child's occupational performance goals (Canadian Occupational Performance Measure) and quality of gait (Edinburgh Visual Gait Score) with a range of secondary outcomes across domains of the International Classification of Disability, Functioning and Health.Discussion: This paper outlines the study protocol including theoretical basis, study hypotheses and outcome measures for this assessor-masked, randomised comparison trial comparing group versus individual models of physiotherapy following intramuscular injections of Botulinum Toxin-A to the lower limbs for ambulant children with cerebral palsy.Trial registration: ACTRN12611000454976

Soil solarization and sustainable agriculture

Pesticide treatments provide an effective control of soilborne pests in vegetable and fruit crops, but their toxicity to animals and people and residual toxicity in plants and soil, and high cost make their use hazardous and economically expensive. Moreover, actual environmental legislation is imposing severe restrictions on the use or the total withdrawal of most soil-applied pesticides. Therefore, an increasing emphasis has been placed on the use of nonchemical or pesticide-reduced control methods. Soil solarization is a nonpesticidal technique which kills a wide range of soil pathogens, nematodes, and weed seeds and seedlings through the high soil temperatures raised by placing plastic sheets on moist soil during periods of high ambient temperature. Direct thermal inactivation of target organisms was found to be the most important mechanism of solarization biocidal effect, contributed also by a heat-induced release of toxic volatile compounds and a shift of soil microflora to microorganisms antagonist of plant pathogens. Soil temperature and moisture are critical variables in solarization thermal effect, though the role of plastic film is also fundamental for the solarizing process, as it should increase soil temperature by allowing the passage of solar radiation while reducing energetic radiative and convective losses. Best solarizing properties were shown by low-density or vynilacetate- coextruded polyethylene formulations, but a wide range of plastic materials were documented as also suitable to soil solarization. Solar heating was normally reported to improve soil structure and increase soil content of soluble nutrients, particularly dissolved organic matter, inorganic nitrogen forms, and available cations, and shift composition and richness of soil microbial communities, with a marked increase of plant growth beneficial, plant pathogen antagonistic or root quick recolonizer microorganisms. As a consequence of these effects, soil solarization was largely documented to increase plant growth and crop yield and quality along more than two crop cycles. Most important fungal plant pathogenic species were found strongly suppressed by the solarizing treatment, as several studies documented an almost complete eradication of economically relevant pathogens, such as Fusarium spp., Phytophthora spp., Pythium spp., Sclerotium spp., Verticillium spp., and their related diseases in many vegetable and fruit crops and in different experimental conditions. Beneficial effects on fungal pathogens were stated to commonly last for about two growing seasons and also longer. Soil solarization demonstrated to be effective for the control of bacterial diseases caused by Agrobacterium spp., Clavibacter michiganensis and Erwinia amylovora, but failed to reduce incidence of tomato diseases caused by Pseudomonas solanacearum. Solarization was generally found less effective on phytoparasitic nematodes than on other organisms, due to their quicker soil recolonization compared to fungal pathogens and weeds, but field and greenhouse studies documented consistant reductions of root-knot severity and population densities of root-knot nematodes, Meloidogyne spp., as well as a satisfactory control of cyst-nematode species, such as Globodera rostochiensis and Heterodera carotae, and bulb nematode Ditylenchus dipsaci. Weeds were variously affected by solar heating, as annual species were generally found almost completely suppressed and perennial species more difficult to control, due to the occurrence deep propagules not exposed to lethal temperature. Residual effect of solarization on weeds was found much more pronounced than on nematodes and most fungal pathogens. Soil solarization may be perfect fit for all situations in which use of pesticides is restricted or completely banned, such as in organic production, or in farms located next to urban areas, or specialty crops with few labeled pesticides. Advantages of solarization also include economic convenience, as demonstrated by many comparative benefit/cost analyses, ease of use by growers, adaptability to many cropping systems, and a full integration with other control tools, which makes this technique perfectly compatible with principles of integrated pest management required by sustainable agriculture