Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delay: A Randomized Clinical Trial Protocol (the DRIVE Study).
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SUBMITTER: Ferrante R
PROVIDER: S-EPMC7029804 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature
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Daily and Weekly Rehabilitation Delivery for Young Children With Gross Motor Delay: A Randomized Clinical Trial Protocol (the DRIVE Study).
Ferrante Rachel R Hendershot Sarah S Baranet Kathy K Barbosa Gardenia G Carey Helen H Maitre Nathalie N Lo Warren W Pan Jeff J Heathcock Jill J
Pediatric physical therapy : the official publication of the Section on Pediatrics of the American Physical Therapy Association 20190401 2
<h4>Purpose</h4>The proposed project tests the principle that frequency of rehabilitation is an important regulator of therapeutic response in infants.<h4>Methods</h4>We will randomize 75 infants with cerebral palsy, 6 to 24 months of age and/or Gross Motor Function Classification System levels III to V (higher severity), to determine the short-term and long-term effects of 3 dosing protocols consisting of an identical number of 2-hour sessions of the same motor learning-based therapy applied ov ...[more]
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Project description:AimTo systematically examine the effect of early motor interventions on motor and locomotor development in infants <1 year of age with motor developmental disability or at risk of motor delay.MethodsPertinent literature from January 2000 to September 2021 was identified by searching the PubMed, Embase, Cochrane, Pedro and Web of Science databases. Selection criteria included interventions starting before 12 months corrected age. Methodological quality was assessed with AACPDM criteria, Mallen score and Cochrane risk of bias methodology. Evaluation procedure was performed using PRISMA protocol (PICO approach) and AMSTAR-2. This review was preregistered in PROSPERO (CRD42021286445).ResultsTen articles met the inclusion criteria; seven had moderate to strong methodological quality. The interventions included treadmill training (n = 3), crawling training (n = 1), "tummy time" (n = 1), physical therapy with neonatal developmental program (n = 1) or Bobath approach (n = 1), treadmill training combined with active leg movements (n = 2) or Bobath physiotherapy (n = 1). The three key characteristics of effective interventions that emerged from the review were: (1) the infants' disability or risk of delay was well-defined; (2) the protocol was standardized and easy to replicate; (3) infants were required to make active movements.ConclusionThere is an urgent need for additional high-quality studies on the effects of early motor interventions on the gross motor and locomotor development of infants with a range of disabilities or risks for delay. Suggestions for future research are outlined.
| S-EPMC9096078 | biostudies-literature
Project description:BackgroundSpinal muscular atrophy (SMA) is a progressive neuromuscular disorder that causes muscle weakness and is the leading genetic cause of infant mortality worldwide. While no definitive cure exists, the approval of 3 genetic-based therapies in Canada since 2018 has led to significant improvements in muscle function for children with SMA. With that, there are no evidence-based rehabilitation interventions and minimal evidence on the combined effects of genetic-based therapies and rehabilitation.ObjectiveThis protocol describes the methodology to assess the feasibility of a twice-weekly outpatient rehabilitation intervention focusing on gross and fine motor function to inform the methodology and sample size of a definitive clinical trial.MethodsWe will conduct a single-center nonrandomized pilot and feasibility trial to explore an outpatient rehabilitation intervention for children aged 6 months to 3 years with SMA treated with genetic-based therapies. Participation in the study will occur over a 25-week period, with a baseline assessment visit followed by a 12-week intervention period and a 12-week nonintervention period. The rehabilitation intervention comprises weekly physical and occupational therapy for 11 weeks. Assessments will occur at baseline (week 0), end of intervention or early withdrawal (week 12), and follow-up (week 24). Predetermined feasibility indicators will evaluate study feasibility across process (recruitment rates, eligibility criteria, adherence rates, retention rates, questionnaire suitability, and acceptability), resource (time, implementation, and execution), management (materials and data), and scientific (safety, tolerability, and preliminary efficacy) domains.ResultsThis project was funded in March 2022, and data will be collected between March 2023 and December 2023. Data analysis will occur between January 2024 and March 2024, with publication expected in the fall of 2024. The protocol for the feasibility trial will be considered successful if it meets the success criteria set out for the feasibility indicators. Indicators of specific interest include all process indicators, as well as time. Exploratory indicators will be reported. Pragmatically, the results of the feasibility trial will inform changes to the protocol and the start-up of a definitive multisite trial.ConclusionsThis novel twice-weekly outpatient rehabilitation intervention will be the first step toward filling the need for an evidence-based rehabilitation intervention for children with SMA treated with genetic-based therapies. It is expected that consistent and intensive rehabilitation therapy will augment functional gains being observed in this population. In the future, a definitive trial will measure the efficacy of the intervention.Trial registrationClinicalTrials.gov NCT05638750; https://clinicaltrials.gov/study/NCT05638750.International registered report identifier (irrid)DERR1-10.2196/46363.
| S-EPMC10654912 | biostudies-literature
Project description:BackgroundChild psychomotor development and factors affecting it today is the subject of interest of many studies, in particular by the experts involved in the protection and improvement of children's health. There is limited evidence on developmental delay among under-five children in low-income countries like Ethiopia. The aim of this study was to assess gross motor developmental delay and associated factors among under-five children attending public health facilities of Dessie city, Ethiopia.MethodsFacility based cross sectional study design was used among under-five children attending under-five OPD in public health facilities of Dessie town from July 1, 2020 to August 15, 2021. A total of, 417 under-five children were systematically selected based on their average number of clients in a month. A pretested structured questionnaire was used for data collection, and data was entered into Epi-data 3.1 version and it was exported to STATA version 14 for analysis. Binary logistic regression analysis was used to identify factors associated with the outcome variable. Odds ratio with 95% confidence interval was used to show the strength and direction of association respectively and P-value less than 0.05 is used to declare statistical significance.ResultsThe overall proportion of gross motor developmental delay among under-five children attending health facilities of Dessie city, Ethiopia was 16.31%, 95% CI: (13.05, 20.19). Increased age of the child [AOR = 0.97, 95% CI: (0.96, 0.99)], increased gestational age during pregnancy [AOR = 0.47, 95% CI: (0.37, 0.65)], being male [AOR = 5.26, 95% CI: (1.76, 15.67)], having history of alcohol intake during pregnancy [AOR = 7.40, 95% CI: (2.36, 23.25)], taking iron during pregnancy [AOR = 0.04, 95% CI: (0.01, 0.15)], facing fetal and/or maternal complication [AOR = 4.98, 95% CI: (1.20, 20.62)], having instrumental delivery [AOR = 9.78, 95% CI: (2.48, 38.60)] were significantly associated with gross motor developmental delay.ConclusionsThe gross motor developmental delay among under-five children was higher as compared to other literatures. This study indicated that, age and sex of the child, iron and alcohol intake during pregnancy, gestational age, mode of delivery and any complication to her and or her neonate were independent variables which showed statistical significant association. The physicians should advise mothers to take iron-folic acid supplement properly and to avoid intake of alcohol during pregnancy. In addition, they should focus on those mothers who faced any complication to her and/or her neonate and better to discourage instrumental delivery unless there are no other options.
| S-EPMC10726544 | biostudies-literature
Project description:Background & purposeActivity-based neuroplasticity and re-organization leads to motor learning via replicating real-life movements. Increased repetition of such movements has growing evidence over last few decades. In particular, computer-game-based rehabilitation is found to be effective, feasible and acceptable for post-stroke upper limb deficits. Our study aims to evaluate the feasibility and effectiveness of 12 weeks of computer-game-based rehabilitation platform (GRP) on fine and gross motor skills post-stroke in India.MethodsThrough this trial we will study the effect of adjunctive in-hospital GRP (using a motion-sensing airmouse with off-the-shelf computer games) in 80 persons with subacute stroke, for reduction of post-stroke upper limb deficits in a single-centre prospective Randomized Open, Blinded End- point trial when compared to conventional therapy alone.ResultsWe intend to evaluate between-group differences using Wolf Motor Function test, Stroke Specific Quality of Life, and GRP assessment tool. Feasibility will be assessed via recruitment rates, adherence to intervention periods, drop-out rate and qualitative findings of patient experience with the intervention.ConclusionThe CARE FOR U trial is designed to test the feasibility and effectiveness of a computer-game based rehabilitation platform in treating upper limb deficits after stroke. In case of positive findings GRP can be widely applicable for stroke populations needing intensive and regular therapy with supervision.
| S-EPMC8564152 | biostudies-literature
Project description:OBJECTIVE:We examined the longitudinal associations of age at achieving gross motor milestones and children's development in a US cohort of singletons and twins. METHODS:In the Upstate KIDS study, a population-based study of children born between 2008 and 2010, information on age at achievement of motor milestones and developmental skills was available in 599 children (314 singletons, 259 twins, and 26 triplets). Mothers reported their children's major motor milestones at ?4, 8, 12, 18, and 24 months. At age 4 years, children's development was clinically assessed by using the Battelle Developmental Inventory, Second Edition (BDI-2). Primary analyses by using multivariate linear regressions were conducted in singletons. We also examined the associations in twins. RESULTS:Later achievement of standing with assistance predicted lower BDI-2 scores in singletons in adjusted models (B per SD of age at achievement, -21.9 [95% confidence interval (CI), -41.5 to -2.2]). Post hoc analysis on age of standing with assistance showed that associations were driven by differences in adaptive skills (B = -5.3 [95% CI, -9.0 to -1.6]) and cognitive skills (B = -5.9 [95% CI, -11.5 to -0.4]). Analyses restricted to twins suggested no association between the age at achievement of milestones and total BDI-2 score after adjustment for gestational age and birth weight. CONCLUSIONS:This study provides evidence that the age of achieving motor milestones may be an important basis for various aspects of later child development. In twins, key predictors of later development (eg, perinatal factors) overshadow the predictive role of milestones in infancy.
| S-EPMC4925077 | biostudies-literature
Project description:Human FOXP2 deficiency has been identified as a cause of hereditary developmental verbal dyspraxia. Another member of the same gene family, FOXP1, has expression patterns that overlap with FOXP2 in some areas of the brain, and FOXP1 and FOXP2 have the ability to form heterodimers. These findings suggest the possibility that FOXP1 may also contribute to proper speech development. However, no such role of FOXP1 has been established to date. Recently, a child was reported who presented with a 3p13-14.1 deletion of four genes, including FOXP1, and a constellation of deficits that included speech delay. In this study, we report the case of a patient with a single deletion of FOXP1. This patient presented with speech and motor developmental delays, a Chiari I malformation, and epileptiform discharges. The nature of the speech deficit is different from the primary oromotor verbal dyspraxia found in patients with FOXP2 deficiency. The patient's developmental deficits may support a role for FOXP1 in the development of verbal and motor skills.
| S-EPMC2987472 | biostudies-other
Project description:IntroductionResearch and continuous quality improvement in pediatric rehabilitation settings require standardized data and a systematic approach to use these data.MethodsWe systematically examined pediatric data concepts from a pediatric learning network to determine capacity for capturing gross motor function (GMF) for children with Cerebral Palsy (CP) as a demonstration for enabling infrastructure for research and quality improvement activities of an LHS. We used an iterative approach to construct phenotype models of GMF from standardized data element concepts based on case definitions from the Gross Motor Function Classification System (GMFCS). Data concepts were selected using a theory and expert-informed process and resulted in the construction of four phenotype models of GMF: an overall model and three classes corresponding to deviations in GMF for CP populations.ResultsSixty five data element concepts were identified for the overall GMF phenotype model. The 65 data elements correspond to 20 variables and logic statements that instantiate membership into one of three clinically meaningful classes of GMF. Data element concepts and variables are organized into five domains relevant to modeling GMF: Neurologic Function, Mobility Performance, Activity Performance, Motor Performance, and Device Use.ConclusionOur experience provides an approach for organizations to leverage existing data for care improvement and research in other conditions. This is the first consensus-based and theory-driven specification of data elements and logic to support identification and labeling of GMF in patients for measuring improvements in care or the impact of new treatments. More research is needed to validate this phenotype model and the extent that these data differentiate between classes of GMF to support various LHS activities.
| S-EPMC8753308 | biostudies-literature
Project description:Rett syndrome is a pervasive neurodevelopmental disorder associated with a pathogenic mutation on the MECP2 gene. Impaired movement is a fundamental component and the Rett Syndrome Gross Motor Scale was developed to measure gross motor abilities in this population. The current study investigated the validity and reliability of the Rett Syndrome Gross Motor Scale. Video data showing gross motor abilities supplemented with parent report data was collected for 255 girls and women registered with the Australian Rett Syndrome Database, and the factor structure and relationships between motor scores, age and genotype were investigated. Clinical assessment scores for 38 girls and women with Rett syndrome who attended the Danish Center for Rett Syndrome were used to assess consistency of measurement. Principal components analysis enabled the calculation of three factor scores: Sitting, Standing and Walking, and Challenge. Motor scores were poorer with increasing age and those with the p.Arg133Cys, p.Arg294* or p.Arg306Cys mutation achieved higher scores than those with a large deletion. The repeatability of clinical assessment was excellent (intraclass correlation coefficient for total score 0.99, 95% CI 0.93-0.98). The standard error of measurement for the total score was 2 points and we would be 95% confident that a change 4 points in the 45-point scale would be greater than within-subject measurement error. The Rett Syndrome Gross Motor Scale could be an appropriate measure of gross motor skills in clinical practice and clinical trials.
| S-EPMC4723034 | biostudies-literature
Project description:BackgroundRecent large-scale initiatives have led to systematically collected phenotypic data for several rare genetic conditions implicated in autism spectrum disorder (ASD). The onset of developmentally expected skills (e.g. walking, talking) serve as readily quantifiable aspects of the behavioral phenotype. This study's aims were: (a) describe the distribution of ages of attainment of gross motor and expressive language milestones in several rare genetic conditions, and (b) characterize the likelihood of delays in these conditions compared with idiopathic ASD.MethodsParticipants aged 3 years and older were drawn from two Simons Foundation Autism Research Initiative registries that employed consistent phenotyping protocols. Inclusion criteria were a confirmed genetic diagnosis of one of 16 genetic conditions (Simons Searchlight) or absence of known pathogenic genetic findings in individuals with ASD (SPARK). Parent-reported age of acquisition of three gross motor and two expressive language milestones was described and categorized as on-time or delayed, relative to normative expectations.ResultsDevelopmental milestone profiles of probands with genetic conditions were marked by extensive delays (including nonattainment), with highest severity in single gene conditions and more delays than idiopathic ASD in motor skills. Compared with idiopathic ASD, the median odds of delay among the genetic groups were higher by 8.3 times (IQR 5.8-16.3) for sitting, 12.4 times (IQR 5.3-19.5) for crawling, 26.8 times (IQR 7.7-41.1) for walking, 2.7 times (IQR 1.7-5.5) for single words, and 5.7 times (IQR 2.7-18.3) for combined words.ConclusionsDelays in developmental milestones, particularly in gross motor skills, are frequent and may be among the earliest indicators of differentially affected developmental processes in specific genetically defined conditions associated with ASD, as compared with those with clinical diagnoses of idiopathic ASD. The possibility of different developmental pathways leading to ASD-associated phenotypes should be considered when deciding how to employ specific genetic conditions as models for ASD.
| S-EPMC9939014 | biostudies-literature
Project description:Sleep has been shown to facilitate the consolidation of newly acquired motor memories. However, the role of sleep in gross motor learning, especially in motor adaptation, is less clear. Thus, we investigated the effects of nocturnal sleep on the performance of a gross motor adaptation task, i.e. riding an inverse steering bicycle. Twenty-six male participants (M = 24.19, SD = 3.70 years) were randomly assigned to a PM-AM-PM (n = 13) or an AM-PM-AM (n = 13) group, i.e. they trained in the evening/morning and were re-tested the next morning/evening and the following evening/morning (PM-AM-PM/AM-PM-AM group) so that every participant spent one sleep as well as one wake interval between the three test sessions. Inverse cycling performance was assessed by speed (riding time) and accuracy (standard deviation of steering angle) measures. Behavioural results showed that in the PM-AM-PM group a night of sleep right after training stabilized performance (accuracy and speed) and was further improved over the subsequent wake interval. In the AM-PM-AM group, a significant performance deterioration after the initial wake interval was followed by the restoration of subjects' performance levels from right after training when a full night of sleep was granted. Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from "how to ride a bicycle" to "how to ride an inverse steering bicycle". Our results demonstrate that sleep facilitates the consolidation of gross motor adaptation, thus adding further insights to the role of sleep for tasks with real-life relevance.
| S-EPMC7540033 | biostudies-literature