Influence of the intelligent knee osteoarthritis lifestyle app (iKOALA) on knee joint pain.

BACKGROUND: The intelligent knee osteoarthritis lifestyle app (iKOALA) has been co-developed with target users to extend the support for physical activity (PA) and musculoskeletal health, beyond short-term structured rehabilitation, using personalised PA guidance, education, and social support. The purpose of this study was to assess the preliminary effectiveness and usability of the iKOALA digital intervention on indices of musculoskeletal (MSK) health, symptoms, and physical activity levels in a broad range of individuals with knee osteoarthritis (KOA) over 12 weeks to inform the design of a larger randomised controlled trial. METHODS: Thirty-eight (33 female) participants living in the UK with a mean (SD) age of 58 (± 9) years diagnosed radiographically or clinically with KOA completed a 12-week user trial of the iKOALA. Participants completed an in-app physical activity questionnaire which intelligently recommended suitable strengthening and aerobic based activities to individuals. Throughout the trial, participants wore a physical activity monitor and were given access to functions within the app (physical activity (PA) reminders, information and education, symptom and PA tracking as well as social support forums) to support them in maintaining their PA plan. Participants completed a MSK questionnaire for chronic symptoms and quality of life (MSK-HQ) as well as an acute iKOALA symptoms questionnaire (confidence, fatigue, mood, pain during the day/night, sleep and ability to walk) in the week prior to starting and following completion of the trial. RESULTS: Physical activity levels were consistent over the 12 weeks with total daily steps of 9102 (± 3514) in week 1, 9576 (± 4214) in week 6 and 9596 (± 3694) in week 12. Group mean changes in all iKOALA MSK symptom scores and the total MSK-HQ (pre 33.1 (7.6) vs. post 40.2 (7.6)) score improved significantly (p < .001, 95% CI [-8.89, -5.16]) over the 12-week period. CONCLUSIONS: Physical activity levels were maintained at a high level throughout the 12 weeks. Significant improvements in mean MSK symptom scores and the total MSK-HQ score were also observed. Efforts to ensure more generalised reach amongst sex and socioeconomic status of the digital intervention in a randomised controlled clinical trial are warranted.

Development of the intelligent knee osteoarthritis lifestyle app: a person-based approach.

BACKGROUND: Knee osteoarthritis is one of the most prevalent long term health conditions globally. Exercise and physical activity are now widely recognised to significantly reduce joint pain, improve physical function and quality of life in patients with knee osteoarthritis. However, prescribed exercise without regular contact with a healthcare professional often results in lower adherence and poorer health outcomes. Digital mobile health (mHealth) technologies offer great potential to support people with long-term conditions such as knee osteoarthritis more efficiently and effectively and with relatively lower cost than existing interventions. However, there are currently very few mHealth interventions for the self-management of knee osteoarthritis. The aim of the present study was to describe the development process of a mHealth app to extend the support for physical activity and musculoskeletal health beyond short-term, structured rehabilitation through self-management, personalised physical activity, education, and social support. METHODS: The development of the intelligent knee osteoarthritis lifestyle application intervention involved an iterative and interconnected process comprising intervention 'planning' and 'optimisation' informed by the person-based approach framework for the development of digital health interventions. The planning phase involved a literature review and collection of qualitative data obtained from focus groups with individuals with knee osteoarthritis (n = 26) and interviews with relevant physiotherapists (n = 5) to generate 'guiding principles' for the intervention. The optimisation phase involved usability testing (n = 7) and qualitative 'think aloud' sessions (n = 6) with potential beneficiaries to refine the development of the intervention. RESULTS: Key themes that emerged from the qualitative data included the need for educational material, modifying activities to suit individual abilities and preferences as well as the inclusion of key features such as rehabilitation exercises. Following a user-trial further changes were made to improve the usability of the application. CONCLUSIONS: Using a systematic person-based, development approach, we have developed the intelligent knee osteoarthritis lifestyle application to help people maintain physical activity behaviour. The app extends the support for physical activity and musculoskeletal health beyond short-term, structured rehabilitation through personalised physical activity guidance, education, and social support.

Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies.

INTRODUCTION: The COVID-19 pandemic impacted clinical research worldwide potentially altering research findings. The study purpose was to measure the effect of the pandemic on recruitment, retention, assessment, and intervention completion rates. METHODS: Enrollment and participation data from a clinical trial evaluating efficacy of a physical therapy intervention for high-risk preterm infants were compared across 3 pandemic periods (February 2019 through November 2021). RESULTS: Recruitment, retention, assessment, and intervention completion rates were lowest during the peak pandemic period. CONCLUSIONS: In compliance with the Human Subjects Review Board, and for the participants' and staff safety, transition from in-person to telehealth or hybrid visits was required to continue this longitudinal study. Despite the negative effect of the pandemic, parental resilience and commitment to the study was clear. Flexibility, quick action, dedication, and efficiency of the research team were key elements enabling study continuation with successful transition to telehealth assessments/interventions during the peak pandemic period.

Research Summit V: Optimizing Transitions From Infancy to Early Adulthood in Children With Neuromotor Conditions.

PURPOSE: The purpose of this executive summary is to review the process and outcomes of the Academy of Pediatric Physical Therapy Research Summit V, "Optimizing transitions from infancy to young adulthood in children with neuromotor disabilities: biological and environmental factors to support functional independence." SUMMARY OF KEY POINTS: An interdisciplinary group of researchers, representatives from funding agencies, and individuals with neuromotor disabilities and their parents participated in an intensive 2.5-day summit to determine research priorities to optimize life transitions for children with neuromotor disabilities. Recommended priorities for research included (1) promoting self-determination and self-efficacy of individuals with neuromotor disabilities and their families, (2) best care at the right time: evidence-based best practice care, led and navigated by families seamlessly across the lifespan, (3) strengthening connections between developmental domains to enhance function and participation, and (4) optimal dosing and timing to support adaptive bone, muscle, and brain plasticity across the lifespan.

Associations of Coexisting Conditions with Healthcare Spending for Children with Cerebral Palsy.

OBJECTIVE: To determine which coexisting conditions have the strongest associations with healthcare use and spending among children with cerebral palsy (CP). STUDY DESIGN: Retrospective analysis of 16 695 children ages 0-18 years with CP - identified with International Classification of Diseases, Ninth Revision, Clinical Modification codes - using Medicaid from January 1, 2013 to December 31, 2013 from 10 states in the Truven MarketScan Medicaid Database. Using generalized linear models, we assessed which coexisting conditions (including medical technology) identified with Agency for Healthcare Research and Quality's Chronic Condition Indicators had the strongest associations with total healthcare spending across the healthcare continuum. RESULTS: Median per-patient annual Medicaid spending for children with CP was $12 299 (IQR $4826-$35 582). Most spending went to specialty (33.1%) and hospital (26.7%) care. The children had a median 6 (IQR 4-10) coexisting conditions; epilepsy was the most common (38.1%). Children with epilepsy accounted for 59.6% ($364 million) of all CP spending. In multivariable analysis, the coexisting conditions most strongly associated with increased spending were tracheostomy (median additional cost per patient = $56 567 [95%CI $51 386-61 748]) and enterostomy (median additional cost per patient = $25 707 [95%CI $23 753-27 660]). CONCLUSIONS: Highly prevalent in children with CP using Medicaid, coexisting conditions correlate strongly with healthcare spending. Tracheostomy and enterostomy, which indicate significant functional impairments in breathing and digestion, are associated with the highest spending. Families, providers, payers, and legislators may leverage these findings when designing policies positioned to enable the best health and care for children with cerebral palsy.

Longitudinal physical activity and sedentary behaviour in preschool-aged children with cerebral palsy across all functional levels.

AIM: To investigate longitudinal changes of habitual physical activity (HPA) and sedentary time in children with cerebral palsy (CP) aged 1 year 6 months to 5 years across all functional abilities. METHOD: At study entry, 95 children (62 males, 33 females) were classified using the Gross Motor Function Classification System (GMFCS) at levels I (50), II (9), III (16), IV (6), and V (14). Physical activity was recorded on a total of 159 occasions at four possible time points: 1 year 6 months to 2 years; 2 years 6 months to 3 years; 4 years; and 5 years using ActiGraph for 3 days. Mixed-effects regression models were used for analyses. RESULTS: Participants classified at GMFCS levels I and II had stable HPA as they aged. HPA significantly decreased at 5 years in children classified at GMFCS levels III to V. Sedentary time significantly increased at 4 years and 5 years in all participants. Annual HPA significantly reduced in children classified at GMFCS levels III to V (-123 counts/min, 95% confidence interval [CI] -206 to -40) while annual sedentary time significantly increased in all participants (GMFCS levels I-II: 2.4%, 95% CI 0.7-4.1; GMFCS levels III-V: 6.9%, 95% CI 4.6-9.2). INTERPRETATION: Children with CP at all GMFCS levels should be encouraged to be physically active from early childhood as HPA levels start to decline from 4 years. Breaks in sedentary time are required for all children with CP from the age of 3 years.

Assessment of body composition in children with cerebral palsy: a cross-sectional study in Norway.

AIM: The assessment of growth and body composition is challenging in children with cerebral palsy (CP). The aim of this study was to compare clinical assessments of body composition with measurements obtained using dual-energy X-ray absorptiometry (DXA) in this population. METHOD: Knee height, weight, and triceps and subscapular skinfold thickness (SFT) were measured in 47 children with CP (age range 8-18y; 18 females, 29 males). Height was estimated from knee height, and used to calculate body mass index (BMI). Using SFT measurements, body fat percentage was calculated by standard ('Slaughter') and CP-modified ('Gurka') equations and compared with results obtained using DXA. RESULTS: Children with severe gross motor function impairments (Gross Motor Function Classification System [GMFCS] level III or IV) exhibited stunted growth and had higher fat percentages and lower lean body mass than children classified in GMFCS level I or II. In 10 children classified as 'thin' according to their BMI (five of whom were assigned thinness grade of 2 or lower), percentage of body fat, as determined by DXA, was normal or high. The Slaughter equations significantly underestimated body fat percentages, whereas the precision of the CP-modified Gurka equations was excellent. INTERPRETATION: In this study, children with CP and severe motor impairments displayed stunted growth, but were not undernourished. Relying solely upon BMIs may be misleading in children with CP. Therefore, clinicians should be encouraged to measure SFT and to calculate body fat percentages using the CP-modified version of the Slaughter equation.

Population pharmacokinetics of oral baclofen in pediatric patients with cerebral palsy.

OBJECTIVE: To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use. SUBJECTS DESIGN: Children (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects. Population PK modeling was performed using NONMEM 7.1 (ICON PLC; Ellicott City, Maryland). RESULTS: R- and S-baclofen showed identical concentration-time profiles. Both baclofen enantiomers exhibited linear and dose/kg-proportional PK, and no sex differences were observed. Average baclofen terminal half-life was 4.5 hours. A 2-compartment PK model with linear elimination and transit absorption steps adequately described concentration-time profiles of both baclofen enantiomers. The mean population estimate of apparent clearance/F was 0.273 L/h/kg with 33.4% inter-individual variability (IIV), and the apparent volume of distribution (Vss/F) was 1.16 L/kg with 43.9% IIV. Delayed absorption was expressed by a mean transit time of 0.389 hours with 83.7% IIV. Body weight, a possible genetic factor, and age were determinants of apparent clearance in these children. CONCLUSION: The PK of oral baclofen exhibited dose-proportionality and were adequately described by a 2-compartment model. Our population PK findings suggest that baclofen dosage can be based on body weight (2 mg/kg per day) and the current baclofen dose escalation strategy is appropriate in the treatment of children with CP older than 2 years of age.

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.

Concurrent Validity of Measures of Upper Extremity Function Derived from Videogame-Based Motion Capture for Children with Hemiplegia.

Objective: Pediatric hemiplegia is associated with wide-ranging deficits in arm and hand motor function, neg-atively impacting participation in daily occupations and quality of life. This study investigated whether performance measures generated during therapy videogame play by children with hemiplegia can be valid indicators of upper extremity motor function. Materials and Methods: Ten children with hemiplegia used a custom therapy game system alternatively using their affected and non-affected hand to provide motion capture data that spans a wide range of motor function status. The children also completed a series of standardized outcome measure assessments with each hand, including the Quality of Upper Extremity Skills Test, the Jebsen Taylor Hand Function Test, and the Wolf Motor Function Test. Results: Statistical analysis using the nonparametric Spearman rank correlation revealed high and significant correlation between videogame-derived motion capture measures, characterizing the speed and smoothness of movements, and the standardized outcome measure assessments. Conclusion: The results suggest that a low-cost motion capture system can be used to monitor a child's motor function status and progress during a therapy program.

Lifelong Fitness in Ambulatory Children and Adolescents with Cerebral Palsy I: Key Ingredients for Bone and Muscle Health.

Physical activity of a sufficient amount and intensity is essential to health and the prevention of a sedentary lifestyle in all children as they transition into adolescence and adulthood. While fostering a fit lifestyle in all children can be challenging, it may be even more so for those with cerebral palsy (CP). Evidence suggests that bone and muscle health can improve with targeted exercise programs for children with CP. Yet, it is not clear how musculoskeletal improvements are sustained into adulthood. In this perspective, we introduce key ingredients and guidelines to promote bone and muscle health in ambulatory children with CP (GMFCS I-III), which could lay the foundation for sustained fitness and musculoskeletal health as they transition from childhood to adolescence and adulthood. First, one must consider crucial characteristics of the skeletal and muscular systems as well as key factors to augment bone and muscle integrity. Second, to build a better foundation, we must consider critical time periods and essential ingredients for programming. Finally, to foster the sustainability of a fit lifestyle, we must encourage commitment and self-initiated action while ensuring the attainment of skill acquisition and function. Thus, the overall objective of this perspective paper is to guide exercise programming and community implementation to truly alter lifelong fitness in persons with CP.

Factors Influencing Receipt and Type of Therapy Services in the NICU.

Understanding the type and frequency of current neonatal intensive care unit (NICU) therapy services and predictors of referral for therapy services is a crucial first step to supporting positive long-term outcomes in very preterm infants. This study enrolled 83 very preterm infants (<32 weeks, gestational age mean 26.5 ± 2.0 weeks; 38 male) from a longitudinal clinical trial. Race, neonatal medical index, neuroimaging, and frequency of therapy sessions were extracted from medical records. The Test of Infant Motor Performance and the General Movement Assessment were administered. Average weekly sessions of occupational therapy, physical therapy, and speech therapy were significantly different by type, but the magnitude and direction of the difference depended upon the discharge week. Infants at high risk for cerebral palsy based on their baseline General Movements Assessment scores received more therapy sessions than infants at low risk for cerebral palsy. Baseline General Movements Assessment was related to the mean number of occupational therapy sessions but not physical therapy or speech therapy sessions. Neonatal Medical Index scores and Test of Infant Motor Performance scores were not predictive of combined therapy services. Medical and developmental risk factors, as well as outcomes from therapy assessments, should be the basis for referral for therapy services in the neonatal intensive care unit.

Relationships between dietary intake and body composition according to gross motor functional ability in preschool-aged children with cerebral palsy.

BACKGROUND/AIMS: We aimed to determine the relationships between energy intake, macronutrient intake and body composition in preschool-aged children with cerebral palsy (CP) according to gross motor functional ability in comparison with typically developing children (TDC). METHODS: Seventy-three children with CP (70% male) of all functional abilities and 16 TDC (63% male) aged 2.8 ± 0.9 years participated in this study. Dietary intake was measured via a validated 3-day weighed food record. Body composition was determined via isotope dilution techniques. RESULTS: There was a significant relationship between energy intake and fat-free mass index, which was stronger in TDC compared to children with CP. There were no significant correlations between other dietary intake and body composition variables, despite differences in body composition as ambulatory status declined. Non-ambulant, tube-fed children had significantly lower protein intakes compared to orally fed children. No other differences in macronutrient intake between children with CP and TDC were apparent. CONCLUSIONS: Results suggest that relationships between dietary intake and body composition are not evident in this population, but develop over time. Physical activity levels may have a greater impact on body composition at this age. Longitudinal research is required to examine these factors.

Effect of a NICU to Home Physical Therapy Intervention on White Matter Trajectories, Motor Skills, and Problem-Solving Skills of Infants Born Very Preterm: A Case Series.

Infants born very preterm (VPT; ≤29 weeks of gestation) are at high risk of developmental disabilities and abnormalities in neural white matter characteristics. Early physical therapy interventions such as Supporting Play Exploration and Early Development Intervention (SPEEDI2) are associated with improvements in developmental outcomes. Six VPT infants were enrolled in a randomised clinical trial of SPEEDI2 during the transition from the neonatal intensive care unit to home over four time points. Magnetic resonance imaging scans and fixel-based analysis were performed, and fibre density (FD), fibre cross-section (FC), and fibre density and cross-section values (FDC) were computed. Changes in white matter microstructure and macrostructure were positively correlated with cognitive, motor, and motor-based problem solving over time on developmental assessments. In all infants, the greatest increase in FD, FC, and FDC occurred between Visit 1 and 2 (mean chronological age: 2.68-6.22 months), suggesting that this is a potential window of time to optimally support adaptive development. Results warrant further studies with larger groups to formally compare the impact of intervention and disparity on neurodevelopmental outcomes in infants born VPT.

Constraint-Induced Movement Therapy for Cerebral Palsy: A Randomized Trial.

OBJECTIVES: With the Children with Hemiparesis Arm and Hand Movement Project (CHAMP) multisite factorial randomized controlled trial, we compared 2 doses and 2 constraint types of constraint-induced movement therapy (CIMT) to usual customary treatment (UCT). METHODS: CHAMP randomly assigned 118 2- to 8-year-olds with hemiparetic cerebral palsy to one of 5 treatments with assessments at baseline, end of treatment, and 6 months posttreatment. Primary blinded outcomes were the assisting hand assessment; Peabody Motor Development Scales, Second Edition, Visual Motor Integration; and Quality of Upper Extremity Skills Test Dissociated Movement. Parents rated functioning on the Pediatric Evaluation of Disabilities Inventory-Computer Adaptive Test Daily Activities and Child Motor Activity Log How Often scale. Analyses were focused on blinded and parent-report outcomes and rank-order gains across all measures. RESULTS: Findings varied in statistical significance when analyzing individual blinded outcomes. parent reports, and rank-order gains. Consistently, high-dose CIMT, regardless of constraint type, produced a pattern of greatest short- and long-term gains (1.7% probability of occurring by chance alone) and significant gains on visual motor integration and dissociated movement at 6 months. O'Brien's rank-order analyses revealed high-dose CIMT produced significantly greater improvement than a moderate dose or UCT. All CIMT groups improved significantly more in parent-reported functioning, compared with that of UCT. Children with UCT also revealed objective gains (eg, 48% exceeded the smallest-detectable assisting hand assessment change, compared with 71% high-dose CIMT at the end of treatment). CONCLUSIONS: CHAMP provides novel albeit complex findings: although most individual blinded outcomes fell below statistical significance for group differences, high-dose CIMT consistently produced the largest improvements at both time points. An unexpected finding concerns shifts in UCT toward higher dosages, with improved outcomes compared with previous reports.

Longitudinal Changes in the Sensorimotor Pathways of Very Preterm Infants During the First Year of Life With and Without Intervention: A Pilot Study.

Objective: Evaluate longitudinal changes in brain microstructure and volumes in very preterm infants during the first year of life with and without intervention.Design: Descriptive pilot study.Methods: Five preterm infants in a three-arm clinical trial, one SPEEDI Early, two SPEEDI Late, and two usual care. Brain structural and diffusion MRI's were acquired within 72 hours after neonatal intensive care unit discharge (n = 5), three months post-baseline (n = 5), and six months post-baseline (n = 3). Fractional anisotropy (FA), Mean diffusivity (MD), and volume metrics were computed for five brain regions.Results: More than 60% of eligible participants completed 100% of the scheduled MRIs. FA and volume increased from baseline to six months across all brain regions. Rate of white matter volume change from baseline to six months was highest in SPEEDI Early.Conclusions: Non-sedated longitudinal MRI is feasible in very preterm infants and appears to demonstrate longitudinal changes in brain structure and connectivity.

Correlates of decline in gross motor capacity in adolescents with cerebral palsy in Gross Motor Function Classification System levels III to V: an exploratory study.

AIM: To explore associations between clinical variables and decline in motor capacity in adolescents with cerebral palsy (CP). METHOD: Participants included 76 males and 59 females, whose mean age at the beginning of the study was 14 years 6 months (SD 2.4, range 11.6-17.9); 51 at Gross Motor Function Classification System (GMFCS) level III, 47 at level IV, and 37 at level V. Ninety-six participants had tetraplegia, 32 had diplegia, and one had hemiplegia. Types of motor disorder were spastic n=98; mixed, n=11; dystonic, n=9; hypotonic, n=7; and ataxic n=3 (seven participants were not classified). Reliable raters collected data annually for 4 years on anthropometric characteristics, the Spinal Alignment and Range of Motion Measure, as well as the Gross Motor Function Measure, 66 items (GMFM-66); participants or their parents reported on health status (using the Health Utilities Questionnaire), pain, and exercise participation (using measures developed for this study). The predicted drop in GMFM-66 scores after childhood was calculated using data on the same children from an earlier study. Correlations were calculated between the drop in GMFM-66 scores and the average and change scores of the clinical variables (the alpha level for statistical significance of this exploratory study was 0.10). RESULTS: The drop in GMFM-66 score was significantly correlated with limitations in range of motion (r=0.42) and spinal alignment (r=0.28), and pain (r=0.16). Increases in triceps skinfold (r=-0.19), mid-arm circumference (r=-0.23), and the ratio of mid-arm circumference to knee height (r=-0.23) were associated with less decline. INTERPRETATION: Preventing range-of-motion limitations and pain experiences and optimizing nutrition might contribute to less decline in the gross motor capacity of adolescents with CP. Further investigation is required to clarify the role other factors that contribute to maintained function over time.