Relationship between early infant motor repertoire and neurodevelopment on the hammersmith infant neurological examination in a developmentally vulnerable First Nations cohort.

AIM: To implement a culturally-adapted screening program aimed to determine the ability of infant motor repertoire to predict early neurodevelopment on the Hammersmith Infant Neurological Examination (HINE) and improve Australian First Nations families' engagement with neonatal screening. METHODS: A prospective cohort of 156 infants (55 % male, mean (standard deviation [SD]) gestational age 33.8 (4.6) weeks) with early life risk factors for adverse neurodevelopmental outcomes (ad-NDO) participated in a culturally-adapted screening program. Infant motor repertoire was assessed using Motor Optimality Score-revised (MOS-R), captured over two videos, 11-13+6 weeks (V1; <14 weeks) and 14-18 weeks (V2; ≥14 weeks) corrected age (CA). At 4-9 months CA neurodevelopment was assessed on the HINE and classified according to age-specific cut-off and optimality scores as; developmentally 'on track' or high chance of either adverse neurodevelopmental outcome (ad-NDO) or cerebral palsy (CP). RESULTS: Families were highly engaged, 139/148 (94 %) eligible infants completing MOS-R, 136/150 (91 %), HINE and 123 (83 %) both. Lower MOS-R at V2 was associated with reduced HINE scores (ß = 1.73, 95 % confidence interval [CI] = 1.03-2.42) and high chance of CP (OR = 2.63, 95%CI = 1.21-5.69) or ad-NDO (OR = 1.38, 95%CI = 1.10-1.74). The MOS-R sub-category 'observed movement patterns' best predicted HINE, infants who score '4' had mean HINE 19.4 points higher than score '1' (95%CI = 12.0-26.9). Receiver-operator curve analyses determined a MOS-R cut-off of <23 was best for identifying mild to severely reduced HINE scores, with diagnostic accuracy 0.69 (sensitivity 0.86, 95%CI 0.76-0.94 and specificity 0.40, 95 % CI 0.25-0.57). A trajectory of improvement on MOS-R (≥2 point increase in MOS-R from 1st to 2nd video) significantly increased odds of scoring optimally on HINE (OR = 5.91, 95%CI 1.16-29.89) and may be a key biomarker of 'on track' development. INTERPRETATION: Implementation of a culturally-adapted program using evidence-based assessments demonstrates high retention. Infant motor repertoire is associated with HINE scores and the early neurodevelopmental status of developmentally vulnerable First Nations infants.

ACTIVE STRIDES-CP: protocol for a randomised trial of intensive rehabilitation (combined intensive gait and cycling training) for children with moderate-to-severe bilateral cerebral palsy.

INTRODUCTION: For children with cerebral palsy (CP), who are marginally ambulant, gross motor capacity peaks between 6 and 7 years of age with a subsequent clinical decline, impacting their ability to engage in physical activity. Active Strides-CP is a novel package of physiotherapy targeting body functions, activity and participation outcomes for children with bilateral CP. This study will compare Active Strides-CP to usual care in a multisite randomised waitlist-controlled trial. METHODS AND ANALYSIS: 150 children with bilateral CP (5-15 years), classified in Gross Motor Function Classification System (GMFCS) levels III and IV will be stratified (GMFCS III vs IV, age 5-10 years; 11-15 years and trial site) and randomised to receive either (1) 8 weeks of Active Strides-CP two times/week for 1.5 hours in clinic and one time/week for 1 hour alternating home visits and telehealth (total dose=32 hours) or (2) usual care. Active Strides-CP comprises functional electrical stimulation cycling, partial body weight support treadmill training, overground walking, adapted community cycling and goal-directed training. Outcomes will be measured at baseline, immediately post-intervention at 9 weeks primary endpoint and at 26 weeks post-baseline for retention. The primary outcome is the Gross Motor Function Measure-66. Secondary outcomes include habitual physical activity, cardiorespiratory fitness, walking speed and distance, frequency/involvement of community participation, mobility, goal attainment and quality of life. Analyses will follow standard principles for randomised controlled trials using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models. A within-trial cost utility analysis will be performed. ETHICS AND DISSEMINATION: The Children's Health Queensland Hospital and Health Service, The University of Queensland, The University of Melbourne and Curtin University Human Research Ethics Committees have approved this study. Results will be disseminated as conference abstracts and presentations, peer-reviewed articles in scientific journals, and institution newsletters and media releases. TRIAL REGISTRATION NUMBER: ACTRN12621001133820.

Maintenance of Functional Gains Following a Goal-Directed and FES-Assisted Cycling Program for Children With Cerebral Palsy.

PURPOSE: This study investigated whether the functional improvements associated with functional electrical stimulation-assisted cycling, goal-directed training, and adapted cycling in children with cerebral palsy were maintained 8 weeks after the intervention ceased. METHODS: The intervention (2 × 1-hour supervised sessions and 1-hour home program/week) ran for 8 weeks. Primary outcomes were the Gross Motor Function Measure (GMFM-88) and the Canadian Occupational Performance Measure (COPM). Secondary outcomes included the GMFM-66 and goal scores, 5 times sit-to-stand test (FTSTS), Participation and Environment Measure-Children and Youth (PEM-CY), Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT), and cycling power output (PO). Outcomes were assessed at baseline, 8 and 16 weeks. RESULTS: Twenty children participated (mean age = 10 years 3 months; SD = 2 years 11 months; Gross Motor Function Classification System II = 5, III = 6, and IV = 9). Improvements were retained above baseline at 16 weeks on the GMFM and COPM. Improvements in cycling PO, PEDI-CAT scores, PEM-CY environmental barriers and FTSTS were also retained. CONCLUSION: Functional improvements in children with cerebral palsy were retained 8 weeks post-intervention.

Australian hip surveillance guidelines at 10 years: New evidence and implementation.

Optimum management of hip displacement in children with cerebral palsy (CP) is facilitated by an approach that focuses on anticipatory and preventive measures. Hip surveillance programs for children with CP were developed at the beginning of the new millennium, with the purpose of identifying hip displacement sufficiently early to permit a choice of effective management options. In the early years, hip surveillance was guided by epidemiological analysis of population-based studies of prevalence. In Australia, a National Hip Surveillance in CP Working Group was first convened in 2005. This resulted in a 2008 Consensus Statement of recommendations published and endorsed by Australasian Academy of Cerebral Palsy and Developmental Medicine (AusACPDM). The group undertook that the recommendations should be reviewed every 5 years to ensure currency and congruency with the emerging evidence base. As new evidence became available, hip surveillance guidelines developed, with the most recent 2020 Australian Hip Surveillance Guidelines endorsed by the AusACPDM. Implementing comprehensive hip surveillance programs has now been shown to improve the natural history of hip dislocations and improve quality of life. Standardised hip surveillance programs can also facilitate planning for multicentre research through harmonisation of data collection. This, in turn, can help with the identification of robust new evidence that is based on large cohort or population studies. Here a review of evidence informing the updated 2020 Hip Surveillance Guidelines is presented.

A qualitative analysis of the experiences of children with cerebral palsy and their caregivers in a goal-directed cycling programme.

PURPOSE: This qualitative thematic analysis aimed to capture the experiences of children with cerebral palsy (CP) and caregivers who completed an 8-week goal-directed cycling programme, to provide insights on engagement and programme feasibility. METHODS: Children with CP (6-18 years, Gross Motor Function Classification Scale (GMFCS) levels II-IV) and caregivers completed semi-structured interviews at the end of the training programme. Interview transcripts were coded by two investigators and systematically organised into themes. A third investigator reviewed the final thematic map. RESULTS: 17 interviews were conducted with 29 participants (11 children: 7-14 years). Four themes emerged: facilitators and challenges to programme engagement; perceived outcomes; the functional-electrical stimulation (FES) cycling experience; and previous cycling participation. Engagement was facilitated by the "therapist's connection," "cycling is fun" and "participant driven goal setting," while "getting there" and "time off school" were identified as challenges. Participants positively linked improved physical function to greater independence. The FES-experience was "fun and challenging," and participants had mixed feelings about electrode "stickiness." Previous cycling participation was limited by access to adapted bikes. CONCLUSIONS: Children with CP enjoy riding bikes. Facilitators and challenges to engagement were identified that hold practical relevance for clinicians. Environmental and personal factors should be carefully considered when developing future programs, to maximise opportunities for success. CLINICAL TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry - ACTRN12617000644369pIMPLICATIONS FOR REHABILITATIONAdapted cycling is a fun and engaging activity for young people with cerebral palsy.Environmental and personal factors should be carefully considered when prescribing adapted or FES cycling programs to this group.Engagement in adapted and FES-cycling programs can be facilitated by access to loan equipment, a goal-directed focus, and positive therapist-child relationship.Participation in adapted cycling is limited by access to adapted cycling equipment.

Functional electrical stimulation cycling, goal-directed training, and adapted cycling for children with cerebral palsy: a randomized controlled trial.

AIM: To test the efficacy of functional electrical stimulation (FES) cycling, goal-directed training, and adapted cycling, compared with usual care, to improve function in children with cerebral palsy (CP). METHOD: The intervention was delivered between 2017 and 2019 and included three sessions per week for 8 weeks (2×1h sessions at a children's hospital, and 1h home programme/week). Hospital sessions included 30 minutes of FES cycling and 30 minutes of goal-directed training. Home programmes included goal-directed training and adapted cycling. The comparison group continued usual care. Primary outcomes were gross motor function assessed by the Gross Motor Function Measure (GMFM) and goal performance/satisfaction assessed using the Canadian Occupational Performance Measure (COPM). Secondary outcomes were sit-to-stand and activity capacity, participation in home, school, and community activities, and power output. Linear regression was used to determine the between-group mean difference immediately post-training completion after adjusting for baseline scores. RESULTS: This randomized controlled trial included 21 participants (mean age=10y 3mo, standard deviation [SD]=3y; Gross Motor Function Classification System level: II=7, III=6, IV=8) who were randomized to the intervention (n=11) or usual care group (n=10). Between-group differences at T2 favoured the intervention group for GMFM-88 (mean difference=7.4; 95% confidence interval [CI]: 2.3-12.6; p=0.007), GMFM-66 (mean difference=5.9; 95% CI: 3.1-8.8; p<0.001), COPM performance (mean difference=4.4; 95% CI: 3.9-5.3; p<0.001) and satisfaction (mean difference=5.2; 95% CI: 4.0-6.4; p<0.001). INTERPRETATION: Children with CP achieved meaningful functional improvements after FES cycling, goal-directed training, and adapted cycling training. Cycling programmes for children with CP should be individualized and goal directed.

Effects of a training programme of functional electrical stimulation (FES) powered cycling, recreational cycling and goal-directed exercise training on children with cerebral palsy: a randomised controlled trial protocol.

INTRODUCTION: Children with cerebral palsy (CP) experience declines in gross motor ability as they transition from childhood to adolescence, which can result in the loss of ability to perform sit-to-stand transfers, ambulate or participate in leisure activities such as cycling. Functional electrical stimulation (FES) cycling is a novel technology that may provide opportunities for children with CP to strengthen their lower limbs, improve functional independence and increase physical activity participation. The proposed randomised controlled trial will test the efficacy of a training package of FES cycling, adapted cycling and goal-directed functional training to usual care in children with CP who are susceptible to functional declines. METHODS AND ANALYSIS: Forty children with CP (20 per group), aged 6-8 years and classified as Gross Motor Function Classification System (GMFCS) levels II-IV will be recruited across South East Queensland. Participants will be randomised to either an immediate intervention group, who will undertake 8 weeks of training, or a waitlist control group. The training group will attend two 1 hour sessions per week with a physiotherapist, consisting of FES cycling and goal-directed, functional exercises and a 1 hour home exercise programme per week, consisting of recreational cycling. Primary outcomes will be the gross motor function measure and Canadian occupational performance measure, and secondary outcomes will include the five times sit-to-stand test, habitual physical activity (accelerometry), power output during cycling and Participation and Environment Measure-Children and Youth. Outcomes will be assessed at baseline, postintervention (8 weeks) and 8 weeks following the intervention (retention). ETHICS AND DISSEMINATION: Ethical approval has been obtained from Griffith University (2018/037) and the Children's Health Queensland Hospital and Health Service (CHQHHS) Human Research Ethics Committee (HREC/17/QRCH/88). Site-specific approval was obtained from CHQHHS research governance (SSA/17/QRCH/145). Results from this trial will be disseminated via publication in relevant peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12617000644369p.

Efficacy of cycling interventions to improve function in children and adolescents with cerebral palsy: a systematic review and meta-analysis.

OBJECTIVES: The aim of this study was to determine the efficacy of cycling to improve function and reduce activity limitations in children with cerebral palsy; the optimal training parameters for improved function; and whether improvements in function can be retained. METHOD: Six databases were searched (until February 2019) and articles were screened in duplicate. Randomized or quasi-randomized controlled trials and pre-post studies were included. Methodological quality was assessed using the Downs and Black scale. Outcomes were reported under the International Classification of Functioning, Disability and Health domains of body functions and activity limitations. Quantitative analyses were completed using RevMan V5.3. RESULTS: A total of 533 articles were identified and 9 studies containing data on 282 participants met full inclusion criteria. Methodological quality ranged from low (14 of 32) to high (28 of 32). Significant improvements were reported for hamstring strength (effect size = 0.77-0.93), cardiorespiratory fitness (effect size = 1.13-1.77), balance (effect size = 1.03-1.29), 3-minute walk test distance (effect size = 1.14) and gross motor function (effect size = 0.91). Meta-analysis suggested that cycling can improve gross motor function (standardized mean difference = 0.35; 95% confidence interval = (-0.01, 0.70); P = 0.05); however, the effect was insignificant when a poor-quality study was omitted. CONCLUSION: Cycling can improve muscle strength, balance and gross motor function in children with cerebral palsy; however, optimal training doses are yet to be determined. There was insufficient data to determine whether functional improvements can be retained. Conclusions were limited by small sample sizes, inconsistent outcome measures and a lack of follow-up testing.

PREDICT-CP: study protocol of implementation of comprehensive surveillance to predict outcomes for school-aged children with cerebral palsy.

OBJECTIVES: Cerebral palsy (CP) remains the world's most common childhood physical disability with total annual costs of care and lost well-being of $A3.87b. The PREDICT-CP (NHMRC 1077257 Partnership Project: Comprehensive surveillance to PREDICT outcomes for school age children with CP) study will investigate the influence of brain structure, body composition, dietary intake, oropharyngeal function, habitual physical activity, musculoskeletal development (hip status, bone health) and muscle performance on motor attainment, cognition, executive function, communication, participation, quality of life and related health resource use costs. The PREDICT-CP cohort provides further follow-up at 8-12 years of two overlapping preschool-age cohorts examined from 1.5 to 5 years (NHMRC 465128 motor and brain development; NHMRC 569605 growth, nutrition and physical activity). METHODS AND ANALYSES: This population-based cohort study undertakes state-wide surveillance of 245 children with CP born in Queensland (birth years 2006-2009). Children will be classified for Gross Motor Function Classification System; Manual Ability Classification System, Communication Function Classification System and Eating and Drinking Ability Classification System. Outcomes include gross motor function, musculoskeletal development (hip displacement, spasticity, muscle contracture), upper limb function, communication difficulties, oropharyngeal dysphagia, dietary intake and body composition, participation, parent-reported and child-reported quality of life and medical and allied health resource use. These detailed phenotypical data will be compared with brain macrostructure and microstructure using 3 Tesla MRI (3T MRI). Relationships between brain lesion severity and outcomes will be analysed using multilevel mixed-effects models. ETHICS AND DISSEMINATION: The PREDICT-CP protocol is a prospectively registered and ethically accepted study protocol. The study combines data at 1.5-5 then 8-12 years of direct clinical assessment to enable prediction of outcomes and healthcare needs essential for tailoring interventions (eg, rehabilitation, orthopaedic surgery and nutritional supplements) and the projected healthcare utilisation. TRIAL REGISTRATION NUMBER: ACTRN: 12616001488493.

Intrathecal baclofen therapy in paediatrics: a study protocol for an Australian multicentre, 10-year prospective audit.

INTRODUCTION: Increasing clinical use of Intrathecal baclofen (ITB) in Australian tertiary paediatric hospitals, along with the need for standardised assessment and reporting of adverse events, saw the formation of the Australian Paediatric ITB Research Group (APIRG). APIRG developed a National ITB Audit tool designed to capture clinical outcomes and adverse events data for all Australian children and adolescents receiving ITB therapy. METHODS AND ANALYSIS: The Australian ITB Audit is a 10 year, longitudinal, prospective, clinical audit collecting all adverse events and assessment data across body functions and structure, participation and activity level domains of the ICF. Data will be collected at baseline, 6 and 12 months with ongoing capture of all adverse event data. This is the first Australian study that aims to capture clinical and adverse event data from a complete population of children with neurological impairment receiving a specific intervention between 2011 and 2021. This multi-centre study will inform ITB clinical practice in children and adolescents, direct patient selection, record and aid decision making regarding adverse events and investigate the impact of ITB therapy on family and patient quality of life. ETHICS AND DISSEMINATION: This project was approved by the individual Human Research Ethics committees at the six Australian tertiary hospitals involved in the study. Results will be published in various peer reviewed journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN 12610000323022; Pre-results.

Evaluation of group versus individual physiotherapy following lower limb intra-muscular Botulinum Toxin-Type A injections for ambulant children with cerebral palsy: A single-blind randomized comparison trial.

This study aimed to evaluate efficacy of group (GRP) versus individual (IND) physiotherapy rehabilitation following lower limb intramuscular injections of Botulinum Toxin-Type A (BoNT-A) for ambulant children with cerebral palsy (CP). Following lower limb BoNT-A injections, 34 children were randomly allocated to GRP (n=17; mean age 7y8m SD 2.0; 13 males; Gross Motor Function Classification System (GMFCS) I=5, II=8, III=4) or IND physiotherapy (n=17; mean age 8y7m SD 2.0; 11 males; GMFCS I=9, II=5, III=3). Primary outcomes were the Canadian Occupational Performance Measure (COPM) and Edinburgh Visual Gait Score (EVGS) assessed at baseline, 10 and 26 weeks post intervention. There were no baseline differences between groups. GRP intervention had greater, but not clinically meaningful, improvement in COPM satisfaction (estimated mean difference EMD 1.7, 95% CI 0.4-3.1; p<0.01) at 26 weeks. Both groups demonstrated clinically significant improvements in COPM performance and satisfaction, but minimal change in quality of gait (EVGS). Six hours of direct physiotherapy (either GRP or IND) with an additional indirect dose (median 16 episodes) of individualized home programme activities following lower limb BoNT-A injections, however, was inadequate to drive clinically meaningful changes in lower limb motor outcomes.

Safety of Botulinum Toxin Type A for Children With Nonambulatory Cerebral Palsy.

OBJECTIVE: To determine safety of intramuscular botulinum toxin A (BoNT-A) injections to reduce spasticity and improve care and comfort of nonambulatory children with cerebral palsy (CP). METHODS: Nonambulatory children with CP were randomly allocated to receive either BoNT-A (n = 23) or sham procedure (n = 18) in Cycle 1. In Cycle 2, the BoNT-A group received a second episode of BoNT-A (n = 20) and sham group received their first episode of BoNT-A (n = 17). A pediatric rehabilitation specialist masked to group allocation graded each adverse event (AE) according to system, severity (mild, moderate, serious, sentinel) and causality (unlikely/unrelated; possible; probable/definite). RESULTS: There was no difference for all moderate/serious AEs between the BoNT-A and sham/control groups in either Cycle 1 (incident rate ratio = 1.30, 95% confidence interval = 0.43-4.00; P = .64) or Cycle 2 (incident rate ratio = 0.72, 95% confidence interval = 0.30-1.75; P = .47). In Cycle 2, 1 serious, 3 moderate (single-episode group), and 24 mild (single-episode group n = 10; 2 episode group n = 14) AEs were probably/definitely related to BoNT-A. CONCLUSIONS: Children receiving BoNT-A were at no greater risk of moderate/serious AEs compared with a sham control procedure. There was no increased risk of moderate/serious AEs between one and two episodes of BoNT-A.

Australian hip surveillance guidelines for children with cerebral palsy: 5-year review.

AIM: To ensure hip surveillance guidelines reflect current evidence of factors influencing hip displacement in children with cerebral palsy (CP). METHOD: A three-step review process was undertaken: (1) systematic literature review, (2) analysis of hip surveillance databases, and (3) national survey of orthopaedic surgeons managing hip displacement in children with CP. RESULTS: Fifteen articles were included in the systematic review. Quantitative analysis was not possible. Qualitative review indicated hip surveillance programmes have decreased the incidence of hip dislocation in populations with CP. The Gross Motor Function Classification System was confirmed as the best indicator of risk for displacement, and evidence was found of hip displacement occurring at younger ages and in young adulthood. Femoral geometry, pelvic obliquity, and scoliosis were linked to progression of hip displacement. A combined data pool of 3366 children from Australian hip surveillance databases supported the effectiveness of the 2008 Consensus Statement to identify hip displacement early. The survey of orthopaedic surgeons supported findings of the systematic review and database analyses. INTERPRETATION: This review rationalized changes to the revised and renamed Australian Hip Surveillance Guidelines for Children with Cerebral Palsy 2014, informing frequency of radiographic examination in lower risk groups and continuation of surveillance into adulthood for adolescents with identified risk factors.

Botulinum toxin A for nonambulatory children with cerebral palsy: a double blind randomized controlled trial.

OBJECTIVES: To examine the efficacy and safety of intramuscular botulinum toxin A (BoNT-A) to reduce spasticity and improve comfort and ease of care in nonambulant children with cerebral palsy (CP). STUDY DESIGN: Nonambulant children with CP (n = 41; Gross Motor Function Classification System level IV = 3, level V = 38; mean age 7.1 years, range 2.3-16 years, 66% male) were randomly allocated to receive either intramuscular BoNT-A injections (n = 23) or sham procedure (n = 18) combined with therapy. The analysis used generalized estimating equations with primary outcome the Canadian Occupational Performance Measure (COPM) at 4 weeks postintervention and retention of effects at 16 weeks. Adverse events (AE) were collected at 2, 4, and 16 weeks by a physician masked to group allocation. RESULTS: There were significant between group differences favoring the BoNT-A-treated group on COPM performance at 4 weeks (estimated mean difference 2.2, 95% CI 0.8, 3.5; P = .002) and for COPM satisfaction (estimated mean difference 2.2, 95% CI 0.5, 3.9; P = .01). These effects were retained at 16 weeks for COPM satisfaction (estimated mean difference 1.8, 95% CI 0.1, 3.5; P = .04). There were more mild AE at 4 weeks for the BoNT-A group (P = .002), however, there were no significant between-group differences in the reporting of moderate and serious AE. CONCLUSIONS: In a double-blind randomized sham-controlled trial, intramuscular BoNT-A and therapy were effective for improving ease of care and comfort for nonambulant children with CP. There was no increase in moderate and severe AE in the children who had BoNT-A injections compared with the sham group.

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.

Australian Cerebral Palsy Child Study: protocol of a prospective population based study of motor and brain development of preschool aged children with cerebral palsy.

BACKGROUND: Cerebral palsy (CP) results from a static brain lesion during pregnancy or early life and remains the most common cause of physical disability in children (1 in 500). While the brain lesion is static, the physical manifestations and medical issues may progress resulting in altered motor patterns. To date, there are no prospective longitudinal studies of CP that follow a birth cohort to track early gross and fine motor development and use Magnetic Resonance Imaging (MRI) to determine the anatomical pattern and likely timing of the brain lesion. Existing studies do not consider treatment costs and outcomes. This study aims to determine the pathway(s) to motor outcome from diagnosis at 18 months corrected age (c.a.) to outcome at 5 years in relation to the nature of the brain lesion (using structural MRI). METHODS: This prospective cohort study aims to recruit a total of 240 children diagnosed with CP born in Victoria (birth years 2004 and 2005) and Queensland (birth years 2006-2009). Children can enter the study at any time between 18 months to 5 years of age and will be assessed at 18, 24, 30, 36, 48 and 60 months c.a. Outcomes include gross motor function (GMFM-66 & GMFM-88), Gross Motor Function Classification System (GMFCS); musculoskeletal development (hip displacement, spasticity, muscle contracture), upper limb function (Manual Ability Classification System), communication difficulties using Communication and Symbolic Behaviour Scales-Developmental Profile (CSBS-DP), participation using the Paediatric Evaluation of Disability Inventory (PEDI), parent reported quality of life and classification of medical and allied health resource use and determination of the aetiology of CP using clinical evaluation combined with MRI. The relationship between the pathways to motor outcome and the nature of the brain lesion will be analysed using multiple methods including non-linear modelling, multilevel mixed-effects models and generalised estimating equations. DISCUSSION: This protocol describes a large population-based study of early motor development and brain structure in a representative sample of preschool aged children with CP, using direct clinical assessment. The results of this study will be published in peer reviewed journals and presented at relevant international conferences. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ACTRN1261200169820).

Evaluation of the effects of botulinum toxin A injections when used to improve ease of care and comfort in children with cerebral palsy whom are non-ambulant: a double blind randomized controlled trial.

BACKGROUND: Children with cerebral palsy (CP) whom are non-ambulant are at risk of reduced quality of life and poor health status. Severe spasticity leads to discomfort and pain. Carer burden for families is significant. This study aims to determine whether intramuscular injections of botulinum toxin A (BoNT-A) combined with a regime of standard therapy has a positive effect on care and comfort for children with CP whom are non-ambulant (GMFCS IV/V), compared with standard therapy alone (cycle I), and whether repeated injections with the same regime of adjunctive therapy results in greater benefits compared with a single injecting episode (cycle II). The regime of therapy will include serial casting, splinting and/or provision of orthoses, as indicated, combined with four sessions of goal directed occupational therapy or physiotherapy. METHOD/DESIGN: This study is a double blind randomized controlled trial. Forty participants will be recruited. In cycle I, participants will be randomized to either a treatment group who will receive BoNT-A injections into selected upper and/or lower limb muscles, or a control group who will undergo sham injections. Both groups will receive occupational therapy and /or physiotherapy following injections. Groups will be assessed at baseline then compared at 4 and 16 weeks following injections or sham control. Parents, treating clinicians and assessors will be masked to group allocation. In cycle II, all participants will undergo intramuscular BoNT-A injections to selected upper and/or lower limb muscles, followed by therapy.The primary outcome measure will be change in parent ratings in identified areas of concern for their child's care and comfort, using the Canadian Occupational Performance Measure (COPM). Secondary measures will include the Care and Comfort Hypertonicity Scale (ease of care), the Cerebral Palsy Quality of Life Questionnaire (CP QoL-Child) (quality of life), the Caregiver Priorities and Child Health Index of Life with Disabilities Questionnaire (CPCHILD©) (health status) and the Paediatric Pain Profile (PPP) (pain). Adverse events will be carefully monitored by a clinician masked to group allocation. DISCUSSION: This paper outlines the theoretical basis, study hypotheses and outcome measures for a trial of BoNT-A injections and therapy for children with non-ambulant CP. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry:N12609000360213.

Hand positioning sense in children with spina bifida myelomeningocele.

This study was undertaken to establish whether children with myelomeningocele have abnormal kinaesthesia of the hands. Twenty-one children with myelomeningocele and 21 control children aged between six and 12 years were involved in the study. The level of kinaesthetic awareness in the hands was measured by examining the child's ability to copy hand positions, using visual cueing and kinaesthetic cueing. Both accuracy and speed of copying hand gestures were assessed. Children with spina bifida were significantly less accurate in achieving hand positions than the control group (chi square(1) = 22.60, p < 0.001), with 73% of the children with spina bifida achieving accurate replications compared with 87% in the control group. Furthermore, children with myelomeningocele were shown to be slower than the controls (F(1,280) = 15.49, p < 0.001). The impaired kinaesthetic awareness found in this study is considered to be one of the factors behind the poor hand function observed in children with myelomeningocele.