Abstract Sakzewski L, Ziviani J, Boyd RN. Best responders after intensive upper-limb training for children with unilateral cerebral palsy. Objective To delineate characteristics of best responders in ...a randomized trial comparing constraint-induced movement therapy (CIMT) to bimanual training for children with unilateral cerebral palsy. Design Secondary analysis of a single-blind matched-pairs randomized comparison trial. Setting Community sporting facilities in 2 Australian capital cities. Participants Children (n=64; mean age, 10.2±2.7y; 52% boys), matched for age, sex, side of hemiplegia, and upper-limb function, were randomized within pairs to CIMT or bimanual training. Sixty-one children who completed CIMT (n=31) or bimanual training (n=30) were included in this study. Interventions Each intervention was delivered in day camps (total 60h over 10d) using a novel circus theme with goal-directed training. Main Outcome Measures Change between baseline, 3, and 26 weeks on the Melbourne Assessment of Unilateral Upper Limb Function (MUUL>7.4%), Assisting Hand Assessment (AHA>4 raw score points), and Canadian Occupational Performance Measure (COPM>2 points) defined best responders. Results Poorer baseline hand function predicted a best response for unimanual capacity of the impaired upper limb (MUUL) immediately postintervention; however, at 26 weeks the odds of achieving a favorable outcome were 21 times greater for CIMT than bimanual training. A favorable response for bimanual performance (AHA) was predicted by immediate change in Jebsen-Taylor hand function test scores. Age (older), left-sided hemiplegia, and lower-baseline COPM performance scores significantly predicted favorable individualized outcomes. Conclusions Secondary analysis of a randomized trial directly comparing 2 upper-limb training models, found children with poorer hand function benefited most. Favorable outcomes for bimanual performance were associated with gains in movement efficiency and older children with left-sided hemiplegia achieved more favorable gains in perceived occupational performance.
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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
IntroductionChildren 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 analysisOne 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 disseminationThe 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 numberACTRN12618000206224.
IntroductionFor 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 analysis150 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 disseminationThe 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 numberACTRN12621001133820.
Introduction
There is strong evidence that goal-directed occupational therapy achieves improvements in motor and self-care outcomes for children with unilateral cerebral palsy. This pilot study aimed ...to describe collaborative goals set in occupational therapy sessions, develop categories to describe session content and determine the percentage of in-session time spent addressing goal practice for children with unilateral cerebral palsy.
Method
Videos of 10 therapy sessions with 10 unique child–therapist dyads were analysed. Session content was categorised into goal practice (goal-directed therapy, meaningful goal-supporting activity) and other activity (non-goal-related, child engagement and behavioural support, parent engagement, transition). Descriptive statistics determined the percentage of in-session time spent in goal practice.
Results
Forty-three goals were set and 41 (95%) were activity focused. Mean percentage of time spent in-session on goal practice was 47.5% (SD 31.1%, range 0%–88.1%). Child behavioural support (4.9%), engaging parents (3.2%), transitioning between activities (6.7%) and non-goal-related activity (45.3%) comprised the remaining session time.
Conclusion
Less than half of session time was spent in goal practice, despite being conducted under a goal-directed framework. Non-goal-related activities comprised nearly half of in-session time. Therapists need to consider how to maximise time spent in goal practice during therapy sessions.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK, VSZLJ
This systematic review aimed to evaluate the psychometric properties and clinical utility of all condition specific outcome measures used to assess quality of life (QOL) in school aged children with ...cerebral palsy (CP).
Relevant outcome measures were identified by searching 8 electronic databases, supplemented by citation tracking. Two independent reviewers completed data extraction and analysis of the measures using a modified version of the CanChild Outcome Measures Rating Form.
From the 776 papers identified 5 outcome measures met the inclusion criteria: the Care and Comfort Hypertonicity Questionnaire (C&CHQ), the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), CP QOL-Child, DISABKIDS and PedsQL 3.0 CP Module. There was evidence of construct validity for all five measures. Content validity was reported for all measures except PedsQL 3.0. The CPCHILD and CP QOL-Child were the only outcome measures to have reported data on concurrent validity. All measures, with the exception of one (C&CHQ) provided evidence of internal reliability. The CPCHILD and the CP-QOL-Child had evidence of test-retest reliability and DISABKIDS had evidence of inter-rater reliability. There were no published data on the responsiveness of these outcome measures.
The CPCHILD and the CP QOL-Child demonstrated the strongest psychometric properties and clinical utility. Further work is needed, for all measures, on data for sensitivity to change.
IntroductionChildren 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 nalysisSixty-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 disseminationThe 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 numberACTRN12621000317897; Australian New Zealand Clinical Trials Registry number.
IntroductionYoung 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 analysis60 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 disseminationEthics 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 numberACTRN126200000719.
IntroductionSchool readiness includes cognitive, socio-emotional, language and physical growth and development domains which share strong associations with life-course opportunities. Children with ...cerebral palsy (CP) are at increased risk of poor school readiness compared with their typically developing peers. Recently, earlier diagnosis of CP has allowed interventions to commence sooner, harnessing neuroplasticity. First, we hypothesise that early referral to intervention for children at-risk of CP will lead to improved school readiness at 4–6 years relative to placebo or care as usual. Second, we hypothesise that receipt of early diagnosis and early intervention will lead to cost-savings in the form of reduced healthcare utilisation.Methods and analysisInfants identified as at-risk of CP ≤6 months corrected age (n=425) recruited to four randomised trials of neuroprotectants (n=1), early neurorehabilitation (n=2) or early parenting support (n=1) will be re-recruited to one overarching follow-up study at age 4–6 years 3 months. A comprehensive battery of standardised assessments and questionnaires will be administered to assess all domains of school readiness and associated risk factors. Participants will be compared with a historical control group of children (n=245) who were diagnosed with CP in their second year of life. Mixed-effects regression models will be used to compare school readiness outcomes between those referred for early intervention versus placebo/care-as-usual. We will also compare health-resource use associated with early diagnosis and intervention versus later diagnosis and intervention.Ethics and disseminationThe Children’s Health Queensland Hospital and Health Service, The University of Queensland, University of Sydney, Monash University and Curtin University Human Research Ethics Committees have approved this study. Informed consent will be sought from the parent or legal guardian of every child invited to participate. Results will be disseminated in peer-reviewed journals, scientific conferences and professional organisations, and to people with lived experience of CP and their families.Trial registration numberACTRN12621001253897.
Abstract Sakzewski L, Ziviani J, Abbott DF, Macdonell RA, Jackson GD, Boyd RN. Participation outcomes in a randomized trial of 2 models of upper-limb rehabilitation for children with congenital ...hemiplegia. Objective To determine if constraint-induced movement therapy (CIMT) is more effective than bimanual training to improve occupational performance and participation in children with congenital hemiplegia. Design Single-blind randomized comparison trial with evaluations at baseline, 3, and 26 weeks. Setting Community facilities in 2 Australian states. Participants Referred sample of children (N=64; mean age ± SD, 10.2±2.7y, 52% boys) were matched for age, sex, side of hemiplegia, and upper-limb function and were randomized to CIMT or bimanual training. After random allocation, 100% of CIMT and 94% of the bimanual training group completed the intervention. Interventions Each intervention was delivered in day camps (total 60h over 10d) using a circus theme with goal-directed training. Children receiving CIMT wore a tailor-made glove during the camp. Main Outcome Measures The primary outcome was the Canadian Occupational Performance Measure (COPM). Secondary measures included the Assessment of Life Habits (LIFE-H), Children's Assessment of Participation and Enjoyment, and School Function Assessment. Results There were no between-group differences at baseline. Both groups made significant changes for COPM performance at 3 weeks (estimated mean difference =2.9; 95% confidence interval CI, 2.3–3.6; P <.001 for CIMT; estimated mean difference=2.8; 95% CI, 2.2–3.4; P <.001 for bimanual training) that were maintained at 26 weeks. Significant gains were made in the personal care LIFE-H domain following CIMT (estimated mean difference=0.5; 95% CI, 0.1–0.9; P =.01) and bimanual training (estimated mean difference=0.6; 95% CI, 0.2–1.1; P =.006). Conclusions There were minimal differences between the 2 training approaches. Goal-directed, activity-based, upper-limb training, addressed through either CIMT or bimanual training achieved gains in occupational performance. Changes in participation on specific domains of participation assessments appear to correspond with identified goals.
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