Individualized orthotic alignment and footwear for balance and mobility in children with bilateral spastic cerebral palsy: A randomized trial.

AIM: To examine whether designed-to-be-rigid ankle-foot orthoses and footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD) would be more effective than designed-to-be-rigid AFO with non-individualized alignment and footwear designs (AFO-FC/NAFD) in children with cerebral palsy (CP). METHOD: Nineteen children with bilateral spastic CP were randomized to AFO-FC/NAFD (n = 10) or AFO-FC/IAFD (n = 9) groups. Fifteen were male, average age 6 years 11 months (range 4 years 2 months-9 years 11 months), classified in Gross Motor Function Classification System levels II (n = 15) and III (n = 4). The Pediatric Balance Scale (PBS), Gait Outcomes Assessment List (GOAL), Patient-Reported Outcomes Measurement Information System (PROMIS), and Orthotic and Prosthetic Users' Survey (OPUS) measures of satisfaction were collected at baseline and after 3 months' wear. RESULTS: Compared with the AFO-FC/NAFD group, those with AFO-FC/IAFD demonstrated greater change in PBS total scores (mean 12.8 [standard deviation 10.5] vs 3.5 [5.8]; p = 0.03) and GOAL total scores (3.5 [5.8] vs -0.44 [5.5]; p = 0.03). There were no significant changes in OPUS or PROMIS scores. INTERPRETATION: After 3 months, individualized orthosis alignment and footwear designs had a greater positive effect on balance and parent-reported mobility than a non-individualized approach. No effect was documented for the PROMIS and OPUS. Results may inform orthotic management for ambulatory children with bilateral spastic CP. WHAT THIS PAPER ADDS: Balance and parent-reported mobility increased more over time for the ankle-foot orthoses and footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD) group. Changes in balance over time suggest a therapeutic effect of the AFO-FC/IAFD approach.

Supportive mobility device use across the life span by individuals with cerebral palsy: A qualitative study.

AIM: To understand the mobility experiences, supportive mobility device (SMD) use, and desired participation outcomes of individuals with cerebral palsy (CP) across the life span, and describe how perspectives of rehabilitation care and professional resources may influence mobility decision-making processes and outcomes. METHOD: In the second phase of an overarching study, focus groups were conducted with 164 participants (68 individuals with CP; 32 females, 36 males; mean age 17y 8mo, SD 11y 11mo, range 3-68y), 74 caregivers (50 females, 24 males), and 22 healthcare providers (14 females, eight males) across four US cities. Sessions were audio-recorded, transcribed, and analysed using constant comparison. RESULTS: Six themes emerged. Five presented across all stakeholder groups: (1) the system is broken; (2) equipment is simultaneously liberating and restricting; (3) adaptation across the life span; (4) designed for transport, not for living; and (5) sharing our stories and sharing resources. One theme (theme 6) was specific to healthcare providers: caught in the middle. INTERPRETATION: This qualitative study underscores the simultaneous value and frustration associated with SMDs as described by the community with CP, and recognition among all stakeholders of the need to improve connections and resource networks within the community with CP to improve SMD design and provision processes across device types and across the life span for individuals with CP. WHAT THIS PAPER ADDS: Supportive mobility devices (SMDs) were most often equated with freedom, participation, and independence. Frustration with SMDs across the life span persisted with regard to design, function, cost, and maintenance. Stakeholders in the community with cerebral palsy are seeking greater networking and resource sharing to enhance SMD provision processes. Access to appropriate SMDs across the life span and the need for system improvement are critical.

OBJETIVO: Compreender as experiências de mobilidade, o uso de dispositivos de mobilidade de apoio e os resultados de participação desejados de pessoas com paralisia cerebral (PC) ao longo da vida e descrever como as perspectivas de cuidados de reabilitação e recursos profissionais podem influenciar os processos de tomada de decisão de mobilidade e resultados. MÉTODO: Na segunda fase de um estudo abrangente, foram realizados grupos focais com 164 participantes (68 pessoas com PC; 32 mulheres, 36 homens; idade média de 17 anos e 8 meses, DP 11 anos e 11 meses, faixa de 3 a 68 anos), 74 cuidadores (50 mulheres, 24 homens) e 22 profissionais de saúde (14 mulheres, oito homens) em quatro cidades dos EUA. As sessões foram gravadas em áudio, transcritas e analisadas por meio de comparação constante. RESULTADOS: Emergiram seis temas. Cinco apresentados em todos os grupos de partes interessadas: (1) o sistema está quebrado; (2) o equipamento está simultaneamente liberando e restringindo; (3) adaptação ao longo da vida; (4) projetado para transporte, não para a vida; e (5) compartilhar nossas histórias e recursos. Um tema (tema 6) era específico para os profissionais de saúde: "pego no meio". INTERPRETAÇÃO: Este estudo qualitativo ressalta o valor e a frustração simultâneos associados aos dispositivos de mobilidade de apoio, conforme descrito pela comunidade com CP, e o reconhecimento entre todas as partes interessadas da necessidade de melhorar as conexões e redes de recursos dentro da comunidade com CP para melhorar os processos de projeto e fornecimento de SMD em todos os dispositivos tipos e ao longo da vida para pessoas com PC.

Comparison of Sagittal Plane Stiffness of Nonarticulated Pediatric Ankle-Foot Orthoses Designed to be Rigid.

INTRODUCTION: When studying the effect of ankle-foot orthoses (AFOs) on gait, it is important to know their sagittal plane stiffness. However, there are no established thresholds for stiffness of non-articulated AFOs designed to be rigid. If wanting to implement published algorithms for ankle-foot orthosis-footwear combinations (AFO-FCs), the AFOs must be equally as stiff as those of the developer of the published AFO-FC algorithms. Hence, the aim of this work was to compare the sagittal plane stiffness of AFOs designed to be rigid, made for a clinical trial in the USA, and following algorithms for AFO-FC designs, to those made and used clinically in the UK by the developer of the AFO-FC algorithms. MATERIALS AND METHODS: Stiffness of 9 pediatric polypropylene AFOs was tested (UK: 6; USA: 3). A computer-controlled motorized device was used in which all AFOs were clamped with the calf shell in a fixed vertical component and the foot section in a rotating plate. Each AFO was tested for 3 trials, loading the foot plate 30 Nm towards dorsiflexion and 20 Nm towards plantarflexion. Torque-angle graphs were plotted and deflection and stiffness compared descriptively across AFOs. RESULTS: Average deflection of AFOs was UK: 3.42±0.83° and USA: 4.81±1.05°. Average stiffness of AFOs was UK: 14.34±3.34 Nm/° and USA: 10.30±1.92 Nm/°. CONCLUSIONS: All tested AFOs deflected only a few degrees in either direction (range: 2.59° to 6.02°), providing the first information reported for the stiffness of rigid pediatric non-articulated AFOs. Overall, the UK AFOs were stiffer and deflected less than the USA study AFOs. AFO design features should be carefully considered as they likely influence sagittal plane stiffness and deflection under load.

Effects of Orthoses on Standing Postural Control and Muscle Activity in Children With Cerebral Palsy.

PURPOSE: This exploratory study assessed postural control and muscle activity in children with cerebral palsy while standing barefoot (BF), in prescribed ankle-foot orthoses (AFOs) and in distal control orthoses (DCOs), which stabilized foot-ankle and deliberately aligned the shank. METHODS: This within-subject study evaluated 10 participants, Gross Motor Functional Classification System level III, across the 3 ankle-foot conditions in: (1) static standing duration and (2) modified Clinical Test of Sensory Interaction on Balance with electromyography (EMG) on 7 muscles. RESULTS: Participants had significantly decreased center of gravity (COG) velocity sway in DCO versus BF and AFO, decreased loss of balance (LOB), and increased standing for DCO versus BF. DCO had minimal effect on EMG activity. CONCLUSIONS: DCO provided significant stabilizing effects on COG sway velocity, standing duration, and LOB. DCO may be effective in balance training. It is unclear whether benefit was derived from stabilization of the ankle joint, the resultant shank alignment, or both.

Physical Activity Measurement in Children Who Use Mobility Assistive Devices: Accelerometry and Global Positioning System.

PURPOSE: To explore the usefulness of combining accelerometry, global positioning systems, and geographic information systems, to describe the time spent in different locations and physical activity (PA) duration/count levels by location for 4 children with cerebral palsy (CP) who use assistive devices (AD). METHODS: A descriptive multiple-case study. RESULTS: Combining the 3 instruments was useful in describing and differentiating duration by location, and amount and location of PA across differing functional levels and AD. For example, the child classified with a Gross Motor Function Classification System (GMFCS) level II exhibited large amounts of PA in community settings. In contrast, the child classified with a GMFCS level V had small amounts of PA and spent most measured time at home. CONCLUSIONS: Combined accelerometry, global positioning system, and geographic information system have potential to capture time spent and amount/intensity of PA relative to locations within daily environments for children with CP who use AD.

Low-Intensity vs High-Intensity Home-Based Treadmill Training and Walking Attainment in Young Children With Spastic Diplegic Cerebral Palsy.

OBJECTIVE: To compare the effect of low-intensity (LI) vs high-intensity (HI) treadmill training (TT) on walking attainment and overall walking activity in children with cerebral palsy (CP). DESIGN: Prospective, multisite, randomized controlled trial. SETTING: Homes of the participants. PARTICIPANTS: Children with spastic diplegic CP, Gross Motor Function Classification System Level I and II, ages 14-32 months (N=19; male, n=8). INTERVENTIONS: The children were randomized to LI TT (2×/wk for 6wk) (n=10) and HI TT (10×/wk for 6wk) (n=9). The TT was carried out by the families with weekly instruction by the researchers. MAIN OUTCOME MEASURES: Children were assessed at study onset, post intervention, and 1 and 4 months post intervention with the Gross Motor Function Measure Dimension D/E (GMFM D/E), average strides per day and percentage of time spent walking with accelerometers, the Peabody Developmental Motor Scales-2 (PDMS-2), Pediatric Evaluation of Disability Index Mobility Scale, timed 10-m and 1-minute walk test, and Functional Mobility Scale. Blinding was conducted for GMFM D/E and PDMS-2. Linear mixed effects regression models were applied to all outcomes. RESULTS: No significant between-group differences were found in any outcome measure at any of the time points. Children in the HI group did not show significant improvement immediately following the intervention in GMFM E (P=.061), while children in the LI group did (P=.003), but no statistically significant differences were detected over time (P=.71). Children in the HI group showed better walking independence on the Functional Mobility Scale at all postintervention assessments. CONCLUSIONS: A twice-weekly dosage was equally effective in improving skills related to walking compared with a 10×/wk program and can be more readily implemented into clinical practice.

Feasibility of using acceleration-derived jerk to quantify bimanual arm use.

BACKGROUND: Accelerometers have become common for evaluating the efficacy of rehabilitation for patients with neurologic disorders. For example, metrics like use ratio (UR) and magnitude ratio (MR) have been shown to differentiate movement patterns of children with cerebral palsy (CP) compared to typically-developing (TD) peers. However, these metrics are calculated from "activity counts" - a measure based on proprietary algorithms that approximate movement duration and intensity from raw accelerometer data. Algorithms used to calculate activity counts vary between devices, limiting comparisons of clinical and research results. The goal of this research was to develop complementary metrics based on raw accelerometer data to analyze arm movement after neurologic injury. METHOD: We calculated jerk, the derivative of acceleration, to evaluate arm movement from accelerometer data. To complement current measures, we calculated jerk ratio (JR) as the relative jerk magnitude of the dominant (non-paretic) and non-dominant (paretic) arms. We evaluated the JR distribution between arms and calculated the 50th percentile of the JR distribution (JR50). To evaluate these metrics, we analyzed bimanual accelerometry data for five children with hemiplegic CP who underwent Constraint-Induced Movement Therapy (CIMT) and five typically developing (TD) children. We compared JR between the CP and TD cohorts, and to activity count metrics. RESULTS: The JR50 differentiated between the CP and TD cohorts (CP = 0.578 ± 0.041 before CIMT, TD = 0.506 ± 0.026), demonstrating increased reliance on the dominant arm for the CP cohort. Jerk metrics also quantified changes in arm use during and after therapy (e.g., JR50 = 0.378 ± 0.125 during CIMT, 0.591 ± 0.057 after CIMT). The JR was strongly correlated with UR and MR (r = - 0.92, 0.89) for the CP cohort. For the TD cohort, JR50 was repeatable across three data collection periods with an average similarity of 0.945 ± 0.015. CONCLUSIONS: Acceleration-derived jerk captured differences in motion between TD and CP cohorts and correlated with activity count metrics. The code for calculating and plotting JR is open-source and available for others to use and build upon. By identifying device-independent metrics that can quantify arm movement in daily life, we hope to facilitate collaboration for rehabilitation research using wearable technologies.

Accelerometer Measurements Indicate That Arm Movements of Children With Cerebral Palsy Do Not Increase After Constraint-Induced Movement Therapy (CIMT).

IMPORTANCE: Constraint-induced movement therapy (CIMT) is a common treatment for children with unilateral cerebral palsy (CP). Although clinic-based assessments have demonstrated improvements in arm function after CIMT, whether these changes are translated and sustained outside of a clinic setting remains unclear. OBJECTIVE: Accelerometers were used to quantify arm movement for children with CP 1 wk before, during, and 4 wk or more after CIMT; measurements were compared with those from typically developing (TD) peers. DESIGN: Observational. SETTING: Tertiary hospital and community. PARTICIPANTS: Seven children with CP (5 boys, 2 girls; average [AVE] age ± standard deviation [SD] = 7.4 ± 1.2 yr) and 7 TD peers (2 boys, 5 girls; AVE age ± SD = 7.0 ± 2.3 yr). INTERVENTION: 30-hr CIMT protocol. OUTCOMES AND MEASURES: Use ratio, magnitude ratio, and bilateral magnitude were calculated from the accelerometer data. Clinical measures were administered before and after CIMT, and parent surveys assessed parent and child perceptions of wearing accelerometers. RESULTS: During CIMT, the frequency and magnitude of paretic arm use among children with CP increased in the clinic and in daily life. After CIMT, although clinical scores showed sustained improvement, the children's accelerometry data reverted to baseline values. Children and parents in both cohorts had positive perceptions of accelerometer use. CONCLUSIONS AND RELEVANCE: The lack of sustained improvement in accelerometry metrics after CIMT suggests that therapy gains did not translate to increased movement outside the clinic. Additional therapy may be needed to help transfer gains outside the clinic. WHAT THIS ARTICLE ADDS: Accelerometer measurements were effective at monitoring arm movement outside of the clinic during CIMT and suggested that additional interventions may be needed after CIMT to sustain benefits.

Walking Performance, Physical Activity, and Validity of the Early Activity Scale for Endurance in Young Children with Cerebral Palsy.

AIMS: To describe the walking performance and physical activity of children with cerebral palsy (CP) by Gross Motor Function Classification System (GMFCS) level, age, sex, and geographical location; and, to examine the concurrent validity of the 4-item Early Activity Scale for Endurance (EASE) to walking performance and physical activity scores. METHODS: Seventy-nine children with CP participated. Parents completed the 4-item EASE. All children wore an Actigraph monitor (n = 79), and children in GMFCS levels I - III also wore a StepWatch monitor (n = 50), for seven days. RESULTS: Only GMFCS level yielded significant differences in average strides taken per day, in strides per day taken faster than 30 strides per minute, in average physical activity counts per minute, and in minutes per day spent in moderate to vigorous physical activity. The 4-item EASE findings were moderately correlated with average physical activity counts per minute (.61, p< .001) and minutes per day spent in moderate to vigorous physical activity (.62, p < .001). CONCLUSIONS: GMFCS level is predictive of both walking performance and physical activity in children with CP. The 4-item EASE may provide a quick and valid way to monitor physical activity in children with CP.

Developmental Trajectories and Reference Percentiles for the 6-Minute Walk Test for Children With Cerebral Palsy.

PURPOSE: The purposes of this study were to document longitudinal developmental trajectories in 6-minute walk test (6MWT) distances and to develop age-specific reference percentiles for children across different Gross Motor Function Classification System (GMFCS) levels. METHODS: A TOTAL OF: 456 children with cerebral palsy ages 3 to 12 years of, GMFCS levels I to III participated. Children's motor function was classified on the GMFCS, and children completed the 6MWT 2 to 5 times in 2 years. RESULTS: Longitudinal developmental trajectories support that 6MWT distances increase with age followed by a tapering, as children approach their functional limit relative to their GMFCS level. Reference percentile graphs were created to monitor change over time. CONCLUSIONS: The 6MWT longitudinal developmental trajectories, reference percentiles, and interpretation of percentile change should assist collaborative and proactive intervention planning relative to functional walking capacity for children with cerebral palsy.

Reliability of StepWatch Activity Monitor to Measure Locomotor Activity in Youth With Lower Limb Salvage.

PURPOSE: The study purpose was to determine the minimum number of monitoring days necessary to reliably capture walking among individuals with lower limb salvage. METHODS: Nineteen participants with lower limb salvage wore an ankle-mounted motion sensor over a 7-day period to obtain step counts. Generalizability theory was used to examine the variance components in step counts (G study) and to determine the appropriate length of activity monitoring using various combinations of days (D study). RESULTS: Mean step counts were higher on weekends than on weekdays. Fifty percent of the total variance in step counts was accounted for by interindividual variability in walking (D study). Eighty percent was reached individually with 4 weekdays, 2 weekend days, or 3 week days + weekend days. CONCLUSION: The study provides data for an appropriate monitoring method to track walking outcomes of rehabilitation for individuals with lower limb salvage.

Pediatric Rehabilitation Services for Children With Cerebral Palsy: What Can Existing Data Sources Tell Us?

Knowledge about associated service utilization patterns and positive outcomes in children with cerebral palsy (CP) of varying levels of severity is a national priority. Families, clinicians, program directors, and policy makers need this information for clinical decision-making and service planning. Existing data sources in the United States that contain information about children with CP, their health, function, well being, and utilization of health services may add to our existing knowledge. We provide a summary of fourteen national, state, and local sources' data: where the data come from, challenges and/or specific considerations when using or accessing information, and specific data elements included. Currently available sources of data can provide meaningful information for policy, practice, and program development. We propose questions for future inquiry and suggest elements that may be useful for when developing data sources specific to physical therapy and individuals with CP. A physical therapy specific registry is warranted.

The Effect of Ankle-Foot Orthoses on Community-Based Walking in Cerebral Palsy: A Clinical Pilot Study.

PURPOSE: To examine the effect of ankle-foot orthoses (AFO) on walking activity in children with cerebral palsy (CP). METHODS: We used a randomized cross-over design with 11 children with bilateral CP, mean age 4.3 years. Subjects were randomized to current AFO-ON or AFO-OFF for 2 weeks and then crossed over. Walking activity (average total steps/day), intensity, and stride rate curves were collected via an ankle accelerometer. Group effects were examined with the Wilcoxon signed-rank test and within-subject effects examined for more than 1 standard deviation change. RESULTS: No significant group difference was found in average total daily step count between treatment conditions (P = .48). For the AFO-ON condition, 2 subjects (18%) increased total steps/day; 4 (36%) increased walking time; 2 (18%) had more strides at a rate of more than 30 strides/min; and 2 (18%) reached higher peak intensity. CONCLUSIONS: Clinically prescribed AFO/footwear did not consistently enhance walking activity levels or intensity. Larger studies are warranted.

Technology for Children With Brain Injury and Motor Disability: Executive Summary From Research Summit IV.

Advances in technology show promise as tools to optimize functional mobility, independence, and participation in infants and children with motor disability due to brain injury. Although technologies are often used in adult rehabilitation, these have not been widely applied to rehabilitation of infants and children. In October 2015, the Academy of Pediatric Physical Therapy sponsored Research Summit IV, "Innovations in Technology for Children With Brain Insults: Maximizing Outcomes." The summit included pediatric physical therapist researchers, experts from other scientific fields, funding agencies, and consumers. Participants identified challenges in implementing technology in pediatric rehabilitation including accessibility, affordability, managing large data sets, and identifying relevant data elements. Participants identified 4 key areas for technology development: to determine (1) thresholds for learning, (2) appropriate transfer to independence, (3) optimal measurement of subtle changes, and (4) how to adapt to growth and changing abilities.

Relation of stride activity and participation in mobility-based life habits among children with cerebral palsy.

OBJECTIVE: To examine the relation between walking performance and participation in mobility-related habits of daily life in children with cerebral palsy (CP). To date, walking outcomes in CP have been capacity-based (what a child does in structured setting). Physical activity performance (what a child really does in daily life) has been documented to affect the relation of capacity-based gross motor measures and participation. DESIGN: Cross-sectional prospective cohort study. SETTING: Regional pediatric specialty care centers. PARTICIPANTS: A cohort of ambulatory children with CP (N=128; age, 2 to 9y; 41% girls; 49% having hemiplegia) participated. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Walking performance was quantified from a 5-day sample of accelerometry data. Stride activity was summarized through the outcomes of the average number of total strides per day (independent of intensity) and the average number of total strides per day at >30 strides/min (marker of intensity). Mobility-based participation was assessed by using the Assessment of Life Habits for Children questionnaire categories of personal care, housing, mobility, and recreation. Regression models were developed controlling for sex, age, cognition, communication, pain, and body composition. RESULTS: The average number of total strides per day was positively associated with the personal care, housing, mobility, and recreation Assessment of Life Habits for Children questionnaire categories (ß=.34-.41, P<.001). The average number of total strides per day at >30 strides/min was associated with all categories (ß=.54-.60, P<.001). CONCLUSIONS: Accelerometry-based walking activity performance is significantly associated with levels of participation in mobility-based life habits for ambulatory children with CP. Evaluation of other factors and the direction of the relation within the International Classification of Functioning, Disability and Health is warranted to inform rehabilitation strategies.

Development and validation of a stakeholder-driven, self-contained electronic informed consent platform for trio-based genomic research studies.

Increasingly long and complex informed consents have yielded studies demonstrating comparatively low participant comprehension and satisfaction with traditional face-to-face approaches. In parallel, interest in electronic consents for clinical and research genomics has steadily increased, yet limited data are available for trio-based genomic discovery studies. We describe the design, development, implementation, and validation of an electronic iConsent application for trio-based genomic research deployed to support genomic studies of cerebral palsy. iConsent development incorporated stakeholder perspectives including researchers, patient advocates, institutional review board members, and genomic data-sharing considerations. The iConsent platform integrated principles derived from prior electronic consenting research and elements of multimedia learning theory. Participant comprehension was assessed in an interactive teachback format. The iConsent application achieved nine of ten proposed desiderata for effective patient-focused electronic consenting for genomic research. Overall, participants demonstrated high comprehension and retention of key human subjects' considerations. Enrollees reported high levels of satisfaction with the iConsent, and we found that participant comprehension, iConsent clarity, privacy protections, and study goal explanations were associated with overall satisfaction. Although opportunities exist to optimize iConsent, we show that such an approach is feasible, can satisfy multiple stakeholder requirements, and can realize high participant satisfaction and comprehension while increasing study reach.