Construct Validity of the Both Hands Assessment Using Wrist-Worn Accelerometers.

AIM: The aim of this study was to evaluate the construct validity of the Both Hands Assessment (BoHA) using activity of the upper limbs as detected by accelerometry in children with bilateral cerebral palsy (CP). METHODS: Observational study of children with CP (n = 44, n = 27 boys, aged 9.1 ± 1.6 years; Manual Ability Classification Scale I: n = 15, II: n = 22, III: n = 7) completing a BoHA assessment while wearing a triaxial accelerometer on each wrist. BoHA Each-Hand sub-scores, BoHA percentage difference between hands, BoHA Units, mean activity for each hand, mean activity asymmetry index and total mean activity were calculated. Linear regressions were used to analyze associations between measures. RESULTS: There were significant, positive associations between BoHA Units and total mean activity (B = 0.86, 95%CI: 0.32, 1.40), BoHA Percentage difference between hands and mean activity asymmetry index (B = 0.95, 95%CI: 0.75,1.15), and BoHA Each-Hand sub-score and mean activity for the non-dominant hand (B = 1.71, 95%CI: 1.16, 2.28), but not the dominant hand (B = 0.50, 95%CI: -0.45, 1.45). CONCLUSIONS: This study provides further evidence for the construct validity of the BoHA as a measure of upper limb performance. Wearable wrist sensors such as accelerometers capture and quantify gross upper limb movement in children with CP but cannot measure fine finger movements captured by the BoHA. CLINICAL TRIALS REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12616001488493 and ACTRN12618000164291).

Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial.

INTRODUCTION: Children with cerebral palsy (CP) participate less in physical activities and have increased sedentary behaviour compared with typically developing peers. Participate CP is a participation-focused therapy intervention for children with CP with demonstrated efficacy in a phase II randomised controlled trial (RCT) to increase perceived performance of physical activity participation goals. This study will test the effectiveness of Participate CP in a multisite phase III RCT. METHODS AND ANALYSIS: One hundred children with CP, aged 8-14 years, classified Gross Motor Function Classification System levels I-IV will be randomised to either (1) receive Participate CP once/week for 1 hour for 12 weeks, or (2) waitlist control, usual care group. The waitlist group will then receive Participate CP following the 26-week retention time point. Outcomes will be assessed at baseline, 12 weeks and then 26 weeks post baseline. The primary outcomes are (1) self-reported participation goal performance on the Canadian Occupational Performance Measure at 12 weeks and (2) daily time in moderate-to-vigorous physical activity. Secondary outcomes include home and community participation frequency, involvement and environmental supportiveness, contextual barriers to participation, quality of life, intrinsic motivation for physical activities, child perception of an autonomy-supportive climate for physical activities and physical literacy at 12 and 26 weeks post study entry. ETHICS AND DISSEMINATION: The Children's Health Queensland Hospital and Health Service, The University of Queensland and the New Zealand Health and Disability Ethics Committees have approved this study. Findings will be disseminated in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12618000206224.

Effect of Active Motor Learning Interventions on Gross Motor Function and Mobility in Children Aged 2 to 6 Years With Bilateral Cerebral Palsy: A Systematic Review and Meta-analysis.

PURPOSE: The purpose of this systematic review is to identify evidence-based interventions to promote active motor learning in children aged 2 to 6 years with bilateral cerebral palsy. SUMMARY OF KEY POINTS: Seven randomized clinical trials of active motor learning interventions targeting gross motor function and mobility were included. Two studies compared context-focused therapy to child-focused therapy. Five studies compared active motor therapy to usual care. Context-focused therapy, child-focused therapy, and active motor therapy were comparable to usual care to improve functional mobility and gross motor function. CONCLUSIONS AND RECOMMENDATIONS FOR CLINICAL PRACTICE: There are limited active intervention studies targeting gross motor function for young children with bilateral cerebral palsy. The authors recommend consideration of the clinical good practice guidelines, dosage parameters, and improved reporting methods when implementing active motor learning interventions targeting gross motor function and mobility for children with cerebral palsy.

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.

Are We Getting It Right? A Scoping Review of Outcomes Reported in Cell Therapy Clinical Studies for Cerebral Palsy.

Cell therapies are an emergent treatment for cerebral palsy (CP) with promising evidence demonstrating efficacy for improving gross motor function. However, families value improvements in a range of domains following intervention and the non-motor symptoms, comorbidities and complications of CP can potentially be targeted by cell therapies. We conducted a scoping review to describe all outcomes that have been reported in cell therapy studies for CP to date, and to examine what instruments were used to capture these. Through a systematic search we identified 54 studies comprising 2066 participants that were treated with a range of cell therapy interventions. We categorized the reported 53 unique outcome instruments and additional descriptive measures into 10 categories and 12 sub-categories. Movement and Posture was the most frequently reported outcome category, followed by Safety, however Quality of Life, and various prevalent comorbidities and complications of CP were infrequently reported. Notably, many outcome instruments used do not have evaluative properties and thus are not suitable for measuring change following intervention. We provide a number of recommendations to ensure that future trials generate high-quality outcome data that is aligned with the priorities of the CP community.

Physical activity and quality of life in children with idiopathic toe walking: a cross sectional study.

OBJECTIVES: To determine if children with idiopathic toe walking (ITW) reach Australian 24-hour movement guidelines. Additional objectives were to identify any factors associated with moderate to vigorous physical activity time of children with ITW. DESIGN: Cross sectional. SETTING: Private practice, public health outpatient, community clinics. PARTICIPANTS: Children between 4 and 14 years, who toe walked and had no medical conditions known to cause ITW. OUTCOME MEASURES: Physical activity intensity, sedentary behaviour and sleep data were collected via an ActiGraph. Physical activity level intensity data were triangulated with the Child Leisure Activities Study Survey (CLASS) to highlight the subjective nature of parent-reported measures. Health related quality of life information was collected using the Parent-Proxy and Child-Self Report Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scale. Regression analyses were used to explore individual factors associated with moderate to vigorous physical activity. RESULTS: Twenty-seven participants, 17(63%) male, age mean = 6.62 (SD = 2.29) years, provided information on physical activity (CLASS n = 18, ActiGraph n = 22), physical functioning and psychosocial functioning domains on the PedsQL (Parent-Proxy n = 25, Child n = 22). All participants exceeded Australian recommendations for physical activity, 44% (8/18) met recommended screen time amounts, and two (9%) met recommended sleep times. The Child-Self Report PedsQL scale score of social functioning was the only factor associated with an increase in physical activity (Coef = 0.48, 95%CI = 0.09 to 0.87, p = 0.019). CONCLUSION: Participants achieved high levels of daily moderate to vigorous physical activity, and this was associated with social functioning. Given current uncertainty regarding benefits and effectiveness of treatment choices for children who have ITW, these findings should encourage clinicians to consider how their treatment recommendations interact with the PA level and sleep of children with ITW. Any treatment choice should also be implemented with consideration of how it may impact social functioning. This study had a small sample size therefore results should be cautiously interpreted and not generalised to all children with ITW.

Study protocol for Running for health (Run4Health CP): a multicentre, assessor-blinded randomised controlled trial of 12 weeks of two times weekly Frame Running training versus usual care to improve cardiovascular health risk factors in children and youth with cerebral palsy.

INTRODUCTION: Children and youth with moderate-severe (Gross Motor Function Classification System (GMFCS) levels II-V) cerebral palsy (CP) participate less frequently in physical activities compared with peers without CP and have elevated risk of cardiorespiratory morbidity and mortality in adulthood. Frame Running (RaceRunning) is a new athletics discipline that is an accessible option for physical activity participation for people with moderate-severe CP. There is no high-quality evidence for the effect of Frame Running on cardiovascular disease in children and young people with CP. The primary aim of this study is to conduct a randomised controlled trial of the effect of 12 weeks of Frame Running training on risk factors for cardiovascular disease. METHODS AND NALYSIS: Sixty-two children and youth with CP (age 8-20 years) in GMFCS levels II-V will be recruited across four sites and randomised to receive either 12 weeks of Frame Running training two times weekly for 60 min, or usual care. Outcomes will be measured at baseline, immediately postintervention (primary endpoint) and 12 weeks later for retention of training effects. The primary outcome is cardiorespiratory fitness as measured by distance covered on Six Minute RaceRunner Test with 1 min heart rate recovery. Other outcomes include blood pressure, objectively measured physical activity, body mass index, waist circumference, percentage body fat, gross motor function capacity, community participation, feasibility, tolerability and safety. Adverse events will be monitored, and participants and their caregivers will be interviewed to discern their experiences of participation in Frame Running. ETHICS AND DISSEMINATION: The Children's Health Queensland Hospital and Health Service and the University of Queensland Human Research Ethics Committees have approved this study. Results will be disseminated in peer-reviewed journals and scientific conferences; through professional and athletic organisations; and to people with CP and their families. TRIAL REGISTRATION NUMBER: ACTRN12621000317897; Australian New Zealand Clinical Trials Registry number.

Descriptive contents analysis of ParticiPAte CP: a participation-focused intervention to promote physical activity participation in children with cerebral palsy.

PURPOSE: ParticiPAte CP is a participation-focused therapy intervention that is effective to increase perceived performance of physical activity (PA) participation goals in children with cerebral palsy (CP). We aimed to characterise the contents of ParticiPAte CP using validated behaviour change frameworks. MATERIALS AND METHODS: Data came from physiotherapist treatment notes and were used to specify: (1) physiotherapist-perceived barriers to behaviour change (using the International Classification of Functioning, Disability and Health Framework [ICF] and Theoretical Domains Framework), intervention content (Behaviour Change Technique Taxonomy v1), intervention functions (Behaviour Change Wheel) and mechanisms of action (Capability, Opportunity, Motivation - Behaviour model). RESULTS: Physiotherapist-perceived barriers to participation were identified in all ICF and Theoretical Domains Framework domains. ParticiPAte CP consisted of 32 behaviour change techniques, delivered via six intervention functions of the Behaviour Change Wheel, especially enablement. All six possible mechanisms of action were identified according to the Capability, Opportunity, Motivation - Behaviour model. These were targeted most frequently through Theoretical Domains Framework domains social influences, environmental context and resources, intentions, skills, knowledge, and beliefs about capabilities. CONCLUSIONS: The content of a PA intervention for children with CP can be specified according to behaviour change frameworks. ParticiPAte CP was complex, with multiple targets, constituent behaviour change techniques and mechanisms of action. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615001064594.Implications for rehabilitationProviding social support to families through practical actions such as motivating conversation, providing information, linking families to community services and participating in activities with children to support their self-efficacy may be a defining feature of effective participation-focused therapies.If children with cerebral palsy (CP) and their families nominate goals for increased frequency of attendance or improved involvement in physical activities (PAs), therapists must identify all important barriers to participation, including behavioural barriers that may be thought of less often (e.g. emotions, beliefs, optimism etc.).Promoting PA participation in children with CP may require a complex or multi-faceted therapy intervention that supports not only physical capability, but also enhances the social and physical opportunity for participation to take place and promotes the psychological capability and motivation for PA of children and families.Therapists or researchers may consider using the Behaviour Change Wheel to prospectively design their own health behaviour intervention for children with CP.

Operationalization, measurement, and health indicators of sedentary behavior in individuals with cerebral palsy: a scoping review.

PURPOSE: To explore the operationalization and measurement of sedentary behavior (SB) in individuals with cerebral palsy (CP). MATERIALS AND METHODS: We searched five databases from 2011 to 2020 for primary studies of experimental, qualitative, longitudinal, or observational designs measuring SB or postures typically characterized as sedentary (sitting, reclining, lying). RESULTS: We screened 1112 citations and selected 47 studies. SB was operationalized through muscle activation, energy expenditure or oxygen consumption in typically sedentary postures (n = 9), and through thresholds and postures used by accelerometers, activity monitors, and a questionnaire to measure time spent in SB (n = 25). Seven out of the eight studies that measured energy expenditure found ≤1.5 metabolic equivalents of task (METs) for sitting and lying. While different accelerometer thresholds were used to measure SB, the behavior (SB) was consistently operationalized as sitting and lying. Little consistency existed in the subpopulation, instruments and cut-points for studies on validity or reliability of tools for measuring SB (n = 19). CONCLUSIONS: Sitting and lying are considered sedentary postures, which is defined as ≤1.5 METs in individuals with CP. There is variability in the tools used to measure SB in individuals with CP. Therefore, consensus on the definition and reporting of SB is needed.Implications for rehabilitationAlthough sedentary behavior (SB) is increased in individuals with cerebral palsy (CP) compared to the typically developing population, there is no standard definition for SB for these individuals; this makes it difficult to synthesize data across studies.Sitting and lying are ≤1.5 METs in individuals with CP, suggesting we only need to measure posture to show change in SB.The commonly used accelerometer cut-point in the typically developing population of ≤100 counts per minute generally has excellent reliability across multiple devices in ambulatory children with CP.

Development of gross motor capacity and mobility performance in children with cerebral palsy: a longitudinal study.

AIM: To describe development of gross motor capacity and mobility performance in children with cerebral palsy. METHOD: This longitudinal cohort study measured gross motor capacity with the Gross Motor Function Measure and mobility performance with the Pediatric Evaluation of Disability Inventory (PEDI) between 18 months and 5 years, and the PEDI - Computer Adaptive Test (PEDI-CAT) between 8 years and 12 years. Longitudinal analyses used mixed-effects regression modelling with interaction between age and Gross Motor Function Classification System (GMFCS). Stability of GMFCS levels over time was measured using agreement. RESULTS: Two hundred and twenty-two children provided 871 observations (median 4 observations, range 1-7). Children classified in GMFCS level I improved in both capacity and performance until 8 to 12 years. Children classified in GMFCS levels II and III continued to develop mobility performance after gross motor capacity had plateaued at 5 years. Children classified in GMFCS level IV plateaued at 5 years in capacity and performance. Children classified in GMFCS level V showed no changes in capacity or performance between 18 months and 8 to 12 years. Stability of GMFCS levels was 73%. INTERPRETATION: Change in mobility performance over time somewhat reflected gross motor capacity trajectories. Continued improvement in mobility performance after plateau of gross motor capacity for children classified in GMFCS levels II and III suggests importance of other personal or environmental factors.

How Do Music Activities Affect Health and Well-Being? A Scoping Review of Studies Examining Psychosocial Mechanisms.

Background: This scoping review analyzed research about how music activities may affect participants' health and well-being. Primary outcomes were measures of health (including symptoms and health behaviors) and well-being. Secondary measures included a range of psychosocial processes such as arousal, mood, social connection, physical activation or relaxation, cognitive functions, and identity. Diverse music activities were considered: receptive and intentional music listening; sharing music; instrument playing; group singing; lyrics and rapping; movement and dance; and songwriting, composition, and improvisation. Methods: Nine databases were searched with terms related to the eight music activities and the psychosocial variables of interest. Sixty-three papers met selection criteria, representing 6,975 participants of all ages, nationalities, and contexts. Results: Receptive and intentional music listening were found to reduce pain through changes in physiological arousal in some studies but not others. Shared music listening (e.g., concerts or radio programs) enhanced social connections and mood in older adults and in hospital patients. Music listening and carer singing decreased agitation and improved posture, movement, and well-being of people with dementia. Group singing supported cognitive health and well-being of older adults and those with mental health problems, lung disease, stroke, and dementia through its effects on cognitive functions, mood, and social connections. Playing a musical instrument was associated with improved cognitive health and well-being in school students, older adults, and people with mild brain injuries via effects on motor, cognitive and social processes. Dance and movement with music programs were associated with improved health and well-being in people with dementia, women with postnatal depression, and sedentary women with obesity through various cognitive, physical, and social processes. Rapping, songwriting, and composition helped the well-being of marginalized people through effects on social and cultural inclusion and connection, self-esteem and empowerment. Discussion: Music activities offer a rich and underutilized resource for health and well-being to participants of diverse ages, backgrounds, and settings. The review provides preliminary evidence that particular music activities may be recommended for specific psychosocial purposes and for specific health conditions.

Preschool HABIT-ILE: study protocol for a randomised controlled trial to determine efficacy of intensive rehabilitation compared with usual care to improve motor skills of children, aged 2-5 years, with bilateral cerebral palsy.

INTRODUCTION: Young children with bilateral cerebral palsy (BCP) often experience difficulties with gross motor function, manual ability and posture, impacting developing independence in daily life activities, participation and quality of life. Hand Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE) is a novel intensive motor intervention integrating upper and lower extremity training that has been developed and tested in older school-aged children with unilateral and BCP. This study aims to compare an adapted preschool version of HABIT-ILE to usual care in a randomised controlled trial. METHODS AND ANALYSIS: 60 children with BCP aged 2-5 years, Gross Motor Function Classification System (GMFCS) II-IV will be recruited. Children will be stratified by GMFCS and randomised using concealed allocation to either receive Preschool HABIT-ILE or usual care. Preschool HABIT-ILE will be delivered in groups of four to six children, for 3 hours/day for 10 days (total 30 hours). Children receiving Preschool HABIT-ILE be provided a written home programme with the aim of achieving an additional 10 hours of home practice (total dose 40 hours). Outcomes will be assessed at baseline, immediately following intervention and then retention of effects will be tested at 26 weeks. The primary outcome will be the Peabody Developmental Motors Scales-Second Edition to evaluate gross and fine motor skills. Secondary outcomes will be gross motor function (Gross Motor Function Measure-66), bimanual hand performance (Both Hands Assessment), self-care and mobility (Pediatric Evaluation of Disability Inventory-Computer Adapted Test), goal attainment (Canadian Occupational Performance Measure), global performance of daily activities (ACTIVLIM-CP), cognition and adaptive function (Behavior Rating Inventory of Executive Function-Preschool Version), habitual physical activity (ActiGraph GT3X+) and quality of life (Infant Toddler Quality of Life Questionnaire and Child Health Utility Index-9). Analyses will follow standard principles for RCTs 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. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Medical Research Ethics Committee Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/59444) and The University of Queensland (2020000336/HREC/19/QCHQ/59444). TRIAL REGISTRATION NUMBER: ACTRN126200000719.

Participation predictors for leisure-time physical activity intervention in children with cerebral palsy.

AIM: To determine the predictors of magnitude of change in response to a participation-focused leisure-time physical activity intervention in children with cerebral palsy (CP) using the ParticiPAte CP protocol. METHOD: We included 33 children (16 males, 17 females) aged 8 to 12 years (mean age=10y, SD=1y 6mo) with CP with pre/postintervention data from a wait-list randomized trial. The hypothesized linear predictors of change in primary outcomes (Canadian Occupational Performance Measure [COPM]-performance and COPM-satisfaction, Belief in Goal Self-Competence Scale (BiGSS), and minutes per day moderate-to-vigorous physical activity [MVPA]) were: age; Gross Motor Function Classification System level; comorbid autism spectrum disorder (ASD); Goal Attainment Scaling T score; Problems in Schools Questionnaire; Physical Activity Climate Questionnaire; Motives for Physical Activities Measure-Revised; and stage of behaviour change. Multivariable models were selected using the Bayesian information criterion. RESULTS: Overcoming barriers to participation, age, and comorbid ASD explained 49% of the variance in change in COPM-performance. Being motivated by interest and/or enjoyment and age explained 32% of the variance in change in COPM-satisfaction. Being motivated by physical activity competence or appearance (extrinsic motivation) explained 24% of the variance in change in BiGSS. Parental autonomy supportiveness, overcoming barriers to participation, appearance motivation, and baseline MVPA explained 59% of the variance in change in MVPA. INTERPRETATION: These findings support a behaviour paradigm for conceptualizing physical activity in children with CP. WHAT THIS PAPER ADDS: Children who met their treatment goals showed a greater increase in physical activity participation. Children who were more intrinsically motivated by physical activity at baseline improved more. Being older and having a comorbid diagnosis of autism spectrum disorder were associated with an attenuated effect of the therapy.

Sedentary Behavior in Children With Cerebral Palsy Between 1.5 and 12 Years: A Longitudinal Study.

PURPOSE: To determine longitudinal change in sedentary behavior in children with cerebral palsy (CP) from 1.5 to 12 years. METHODS: Ninety-one children, Gross Motor Function Classification System (GMFCS) levels I to III, who participated in a large longitudinal cohort study were participants. Longitudinal change was analyzed in objectively measured sedentary behavior and associations with sex, body mass index Z score, and socioeconomic status. Moderate-vigorous intensity physical activity (MVPA) was estimated at 8 to 12 years. RESULTS: Average sedentary minutes/day peaked at 4 years in children at GMFCS I and 5 years in children at GMFCS II to III, then plateaued. Male sex was associated with increased sedentary behavior. At 8 to 12 years, children at GMFCS I, II, and III accumulated on average 54, 47, and 14 minutes/day, respectively, of MVPA. CONCLUSIONS: When measured to 12 years, sedentary behavior peaks by 5 years for children with CP who are walking with differences in trajectory according to GMFCS.

Protocol for a multisite randomised trial of Hand-Arm Bimanual Intensive Training Including Lower Extremity training for children with bilateral cerebral palsy: HABIT-ILE Australia.

INTRODUCTION: Children with bilateral cerebral palsy often experience difficulties with posture, gross motor function and manual ability, impacting independence in daily life activities, participation and quality of life (QOL). Hand-Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE) is a novel intensive motor intervention integrating upper and lower extremity training. This study aimed to compare HABIT-ILE to usual care in a large randomised controlled trial (RCT) in terms of gross motor function, manual ability, goal attainment, walking endurance, mobility, self-care and QOL. A within-trial cost-utility analysis will be conducted to synthesise costs and benefits of HABIT-ILE compared with usual care. METHODS AND ANALYSIS: 126 children with bilateral cerebral palsy aged 6-16 years will be recruited across three sites in Australia. Children will be stratified by site and Gross Motor Function Classification System and randomised using concealed allocation to either receiving HABIT-ILE immediately or being waitlisted for 26 weeks. HABIT-ILE will be delivered in groups of 8-12 children, for 6.5 hours per day for 10 days (total 65 hours, 2 weeks). Outcomes will be assessed at baseline, immediately following intervention, and then retention of effects will be tested at 26 weeks. Primary outcomes will be the Gross Motor Function Measure and ABILHAND-Kids. Secondary outcomes will be brain structural integrity, walking endurance, bimanual hand performance, self-care, mobility, performance and satisfaction with individualised goals, and QOL. Analyses will follow standard principles for RCTs 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. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Medical Research Ethics Committee of Children's Health Queensland Hospital and the Health Service Human Research Ethics Committee (HREC/17/QRCH/282) of The University of Queensland (2018000017/HREC/17/QRCH/2820), and The Cerebral Palsy Alliance Ethics Committee (2018_04_01/HREC/17/QRCH/282). TRIAL REGISTRATION NUMBER: ACTRN12618000164291.

Efficacy of Participation-Focused Therapy on Performance of Physical Activity Participation Goals and Habitual Physical Activity in Children With Cerebral Palsy: A Randomized Controlled Trial.

OBJECTIVE: To determine the efficacy of a participation-focused therapy (ParticiPAte CP) on leisure-time physical activity goal performance and satisfaction and habitual physical activity (HPA) in children with CP. DESIGN: Randomized waitlist-controlled trial. SETTING: Home and community. PARTICIPANTS: Children classified at Gross Motor Function Classification System (GMFCS) levels I-III were recruited (n=37; 18 males; mean age ± SD, 10.0±1.4y) from a population-based register. INTERVENTIONS: Participants were randomized to ParticiPAte CP (an 8-wk goal-directed, individualized, participation-focused therapy delivered by a physical therapist) or waitlist usual care. MAIN OUTCOME MEASURES: The primary outcome was Canadian Occupational Performance Measure. Accelerometers were worn for objective measurement of HPA (min/d moderate-to-vigorous physical activity [MVPA], sedentary time). Barriers to participation, community participation, and quality-of-life outcomes were also collected. Data were analyzed by intention-to-treat using generalized estimating equations. RESULTS: ParticiPAte CP led to significant improvements in goal performance (mean difference [MD]=3.58; 95% confidence interval [95% CI], 2.19-4.97; P<.001), satisfaction (MD=1.87; 95% CI, 0.37-3.36, P=.014), and barriers to participation (MD=26.39; 95% CI, 6.13-46.67; P=.011) compared with usual care at 8 weeks. There were no between-group differences on minutes per day of MVPA at 8 weeks (MD=1.17; 95% CI, -13.27 to 15.61; P=.874). There was a significant difference in response to intervention between participants who were versus were not meeting HPA guidelines at baseline (MD=15.85; 95% CI, 3.80-27.89; P<.0061). After ParticiPAte CP, low active participants had increased average MVPA by 5.98±12.16 minutes per day. CONCLUSION: ParticiPAte CP was effective at increasing perceived performance of leisure-time physical activity goals in children with CP GMFCS I-III by reducing modifiable barriers to participation. This did not translate into change in HPA on average; however, low active children may have a clinically meaningful response.

ParticiPAte CP: a protocol of a randomised waitlist controlled trial of a motivational and behaviour change therapy intervention to increase physical activity through meaningful participation in children with cerebral palsy.

INTRODUCTION: Children with cerebral palsy (CP) participate in leisure-time physical activities (PA) less often, with less intensity and reduced diversity than their typically developing peers. Participation in leisure-time physical activities may be an important source of habitual physical activity (HPA) for children with CP, who as a group have lower levels of HPA and increased sedentary time compared with their typically developing peers. The proposed study aims to compare the efficacy of a participation focused therapy (ParticiPAte CP) to usual care in a pragmatic, randomised waitlist controlled trial. METHODS AND ANALYSIS: Thirty-six children with CP (18 in each group), classified as Gross Motor Function Classification System levels I to III, aged between 8 and 12 years will be recruited across South East Queensland, Australia. Children will be randomised to receive either ParticiPAte CP or waitlist usual care using concealed allocation. ParticiPAte CP is an individually tailored, goal-directed intervention model of pragmatic participation-focused therapy using a toolbox of evidence-based strategies in the treatment of children with CP. This will include goal-setting; identification of barriers and facilitators to participation goals, strategy formation and planning and communication guided by principles of Self-Determination Theory using strategies of Motivational Interviewing. The intervention comprises 8 weekly sessions of 1 hour duration conducted by a physiotherapist in the child's home or community. TRIAL REGISTRATION NUMBER: ACTRN12615001064594.

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.

The efficacy of interventions to increase physical activity participation of children with cerebral palsy: a systematic review and meta-analysis.

AIM: To determine efficacy of therapy and behaviour change interventions to increase the level of participation in leisure-time physical activities (LTPAs) and habitual physical activity in children and young people with cerebral palsy. METHOD: Five databases were systematically searched. Included studies were randomized or comparison designs. Methodological quality was assessed with a modified Downs and Black Scale. Quantitative analysis was performed using RevMan 5.3 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark). Intervention components and behaviour change constructs were mapped against (1) the International Classification of Functioning, Disability and Health (ICF) and (2) the Theoretical Domains Framework. RESULTS: Searches yielded 2487 unique articles. Eight studies (nine articles) were included. Interventions included physical training, activity level training, combined physical training and behaviour change therapy, online behaviour change modules, and context-focused therapy. Study quality varied from moderate to high. There was a small, significant effect of physical activity intervention compared with passive usual care on level of habitual physical activity, of approximately 1000 additional steps per day (standardized mean difference 0.34, 95% confidence interval 0.03-0.66, p=0.030). There was no significant effect on LTPA participation (standardized mean difference 0.40, 95% confidence interval -0.40 to 1.19, p=0.330). INTERPRETATION: Therapy and behaviour change interventions have the potential to increase LTPA participation of children and young people with cerebral palsy, although there is a need to depart from impairment-focused approaches. Inappropriate selection of outcomes and inadequate reporting of complex interventions are barriers to progress in this field.