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1.  Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study 
This pilot and feasibility study examined the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception of pain during oral prophylaxis for children with autism spectrum disorder (ASD). Participants were 44 children ages 6-12 (n=22 typical, n=22 ASD). In an experimental crossover design, each participant underwent two professional dental cleanings, one in a regular dental environment (RDE) and one in a SADE, administered in a randomized and counterbalanced order three to four months apart. Outcomes included measures of physiological anxiety, behavioral distress, pain intensity, and sensory discomfort. Both groups exhibited decreased physiological anxiety and reported lower pain and sensory discomfort in the SADE condition compared to RDE, indicating a beneficial effect of the SADE.
doi:10.1007/s10803-015-2450-5
PMCID: PMC4554774  PMID: 25931290
Autism Spectrum Disorder; Electrodermal Activity; Skin Conductance; Sensory Processing; Oral health; Occupational therapy; Dental Anxiety
2.  The effect of lactation educators implementing a telephone-based intervention among low-income Hispanics: A randomised trial 
Health education journal  2015;74(4):424-441.
Objectives
To assess whether a phone-based breastfeeding intervention delivered by lactation educators influenced exclusive breastfeeding rates amongst low-income Hispanic women in the USA.
Design
Randomised two-group design
Setting
Pregnant low-income Hispanic women (298) were recruited from community health clinics in Los Angeles County (USA) and randomly assigned to either a control or an intervention group.
Methods
Data relating to the factors associated with breastfeeding were collected during the third trimester. Breastfeeding outcome data was collected at 72 hours, one month, three months, and six months postpartum.
Results
There were no differences between the groups in rates of breastfeeding initiation. There was a significant difference in the duration of exclusive breastfeeding among participants during the infant's first week of life. While not significant, after controlling for covariates and intent to breastfeed at third trimester, the duration of exclusive breastfeeding amongst all participants was, on average, longer for intervention group mothers than control group mothers. Additionally, , the intervention group mothers were more likely to report exclusive and only breastfeeding at all data points compared to the control group, and less likely to discontinue breastfeeding.
Conclusion
Findings from this study suggest that telephone-based breastfeeding interventions delivered by a lactation educator show promise as a cost-effective strategy for improving both the quantity and duration of breastfeeding among low-income Hispanic women in the USA. Intervention group mothers not only sustained breastfeeding for a longer durations, but also provided their infants with greater amounts of breast milk over these longer durations.
doi:10.1177/0017896914542666
PMCID: PMC4771064  PMID: 26941454
Lactation education; telephone intervention; effects; low income; USA
3.  Inter-rater Reliability of the Wolf Motor Function Test-Functional Ability Scale: Why it Matters 
Background
One important objective for clinical trialists in rehabilitation is determining efficacy of interventions to enhance motor behavior. In part, limitation in the precision of measurement presents a challenge. The few valid, low-cost observational tools available to assess motor behavior cannot escape the variability inherent in test administration and scoring. This is especially true when there are multiple evaluators and raters as in the case of multi-site randomized controlled trials (RCT). One way to enhance reliability and reduce variability is to implement rigorous quality control (QC) procedures.
Objective
This paper describes a systematic QC process used to refine the administration and scoring procedures for the Wolf Motor Function Test (WMFT)-Functional Ability Scale (FAS).
Methods
The QC process, a systematic focus-group collaboration was developed and used for a phase III RCT, which enlisted multiple evaluators and an experienced WMFT-FAS Rater Panel.
Results
After three staged refinements to the administration and scoring instructions, we achieved a sufficiently high inter-rater reliability (weighted kappa = 0.8).
Conclusions/Implications
A systematic focus-group process was shown to be an effective method to improve reliability of observational assessment tools for motor behavior in neurorehabilitation. A reduction in noise-related variability in performance assessments will increase power and potentially lower the number needed to treat. Improved precision of measurement can lead to more cost effective and efficient clinical trials. Finally, we suggest that improved precision in measures of motor behavior may provide more insight into recovery mechanisms than a single measure of movement time alone.
doi:10.1177/1545968314553030
PMCID: PMC4400190  PMID: 25323459
quality; observational; motor control; impairment; assessment; stroke
4.  The Use of Refundable Tax Credits to Increase Low-Income Children's After-School Physical Activity Level 
Objective
The present study investigates the extent to which a refundable tax credit could be used to increase low income children's after-school physical activity levels.
Methods
An experimental study was conducted evaluating the effectiveness of an intervention offering a simulated refundable tax credit to parents of elementary school-age children (n=130) for enrollment in after-school physical activity programs. A randomized-controlled design was used, with data collected at baseline, immediately following the four month intervention (post-intervention), and six-weeks after the end of the intervention (follow-up). Evaluation measures included: (a) enrollment rate, time spent, weekly participation frequency, duration of enrollment and long term enrollment patterns in after-school physical activity programs; and (b) moderate-to-vigorous physical activity (MVPA).
Results
The simulated tax credits did not significantly influence low- income children's rates of enrollment in after-school physical activity programs, frequency of participation, time spent in after-school physical activity programs, and overall moderate-to-vigorous intensity physical activity at post-intervention or follow-up.
Conclusion
The use of refundable tax credits as incentives to increase participation in after-school physical activity programs in low-income families may have limited effectiveness. Lawmakers might consider other methods of fiscal policy to promote physical activity such as direct payment to after-school physical activity program providers for enrolling and serving a low- income child in a qualified program, or improvements to programming and infrastructure.
doi:10.1123/jpah.2014-0058
PMCID: PMC4348362  PMID: 25184738
obesity; children physical activity; tax credits
5.  Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke 
JAMA  2016;315(6):571-581.
IMPORTANCE
Clinical trials suggest that higher doses of task-oriented training are superior to current clinical practice for patients with stroke with upper extremity motor deficits.
OBJECTIVE
To compare the efficacy of a structured, task-oriented motor training program vs usual and customary occupational therapy (UCC) during stroke rehabilitation.
DESIGN, SETTING, AND PARTICIPANTS
Phase 3, pragmatic, single-blind randomized trial among 361 participants with moderate motor impairment recruited from 7 US hospitals over 44 months, treated in the outpatient setting from June 2009 to March 2014.
INTERVENTIONS
Structured, task-oriented upper extremity training (Accelerated Skill Acquisition Program[ASAP]; n = 119); dose-equivalent occupational therapy (DEUCC; n = 120); or monitoring-only occupational therapy (UCC; n = 122). The DEUCC group was prescribed 30 one-hour sessions over 10 weeks; the UCC group was only monitored, without specification of dose.
MAIN OUTCOMES AND MEASURES
The primary outcome was 12-month change in log-transformed Wolf Motor Function Test time score (WMFT, consisting of a mean of 15 timed arm movements and hand dexterity tasks). Secondary outcomes were change in WMFT time score (minimal clinically important difference [MCID] = 19 seconds) and proportion of patients improving ≥25 points on the Stroke Impact Scale (SIS) hand function score (MCID = 17.8 points).
RESULTS
Among the 361 randomized patients (mean age, 60.7 years; 56% men; 42% African American; mean time since stroke onset, 46 days), 304 (84%) completed the 12-month primary outcome assessment; in intention-to-treat analysis, mean group change scores (log WMFT, baseline to 12 months) were, for the ASAP group, 2.2 to 1.4 (difference, 0.82); DEUCC group, 2.0 to 1.2 (difference, 0.84); and UCC group, 2.1 to 1.4 (difference, 0.75), with no significant between-group differences (ASAP vs DEUCC:0.14; 95% CI, −0.05 to 0.33; P = .16; ASAP vs UCC: −0.01; 95% CI, −0.22 to 0.21; P = .94; and DEUCC vs UCC: −0.14; 95% CI, −0.32 to 0.05; P = .15). Secondary outcomes for the ASAP group were WMFT change score, −8.8 seconds, and improved SIS, 73%; DEUCC group, WMFT, −8.1 seconds, and SIS, 72%; and UCC group, WMFT, −7.2 seconds, and SIS, 69%, with no significant pairwise between-group differences (ASAP vs DEUCC: WMFT, 1.8 seconds; 95% CI, −0.8 to 4.5 seconds; P = .18; improved SIS, 1%; 95% CI, −12% to 13%; P = .54; ASAP vs UCC: WMFT, −0.6 seconds, 95% CI, −3.8 to 2.6 seconds; P = .72; improved SIS, 4%; 95% CI, −9% to 16%; P = .48; and DEUCC vs UCC: WMFT, −2.1 seconds; 95% CI, −4.5 to 0.3 seconds; P = .08; improved SIS, 3%; 95% CI, −9% to 15%; P = .22). A total of 168 serious adverse events occurred in 109 participants, resulting in 8 patients withdrawing from the study.
CONCLUSIONS AND RELEVANCE
Among patients with motor stroke and primarily moderate upper extremity impairment, use of a structured, task-oriented rehabilitation program did not significantly improve motor function or recovery beyond either an equivalent or a lower dose of UCC upper extremity rehabilitation. These findings do not support superiority of this program among patients with motor stroke and primarily moderate upper extremity impairment.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00871715
doi:10.1001/jama.2016.0276
PMCID: PMC4795962  PMID: 26864411
6.  Patterns of Risk for Multiple Co‐Occurring Medical Conditions Replicate Across Distinct Cohorts of Children with Autism Spectrum Disorder 
Autism Research  2015;8(6):771-781.
Children with autism spectrum disorder (ASD) may present with multiple medical conditions in addition to ASD symptoms. This study investigated whether there are predictive patterns of medical conditions that co‐occur with ASD, which could inform medical evaluation and treatment in ASD, as well as potentially identify etiologically meaningful subgroups. Medical history data were queried in the multiplex family Autism Genetic Resource Exchange (AGRE). Fourteen medical conditions were analyzed. Replication in the Simons Simplex Collection (SSC) was attempted using available medical condition data on gastrointestinal disturbances (GID), sleep problems, allergy and epilepsy. In the AGRE cohort, no discrete clusters emerged among 14 medical conditions. GID and seizures were enriched in unaffected family members, and together with sleep problems, were represented in both AGRE and SSC. Further analysis of these medical conditions identified predictive co‐occurring patterns in both samples. For a child with ASD, the presence of GID predicts sleep problems and vice versa, with an approximately 2‐fold odds ratio in each direction. These risk patterns were replicated in the SSC sample, and in addition, there was increased risk for seizures and sleep problems to co‐occur with GID. In these cohorts, seizure alone was not predictive of the other conditions co‐occurring, but behavioral impairments were more severe as the number of co‐occurring medical symptoms increased. These findings indicate that interdisciplinary clinical care for children with ASD will benefit from evaluation for specific patterns of medical conditions in the affected child and their family members. Autism Res 2015, 8: 771–781. © 015 The Authors Autism Research published by Wiley Periodicals, Inc. on behalf of International Society for Autism Research.
doi:10.1002/aur.1492
PMCID: PMC4736680  PMID: 26011086
gastrointestinal disturbances; sleep; seizure; medical symptoms
7.  Daily Quantity of Infant Leg Movement: Wearable Sensor Algorithm and Relationship to Walking Onset 
Sensors (Basel, Switzerland)  2015;15(8):19006-19020.
Background: Normative values are lacking for daily quantity of infant leg movements. This is critical for understanding the relationship between the quantity of leg movements and onset of independent walking, and will begin to inform early therapy intervention for infants at risk for developmental delay. Methods: We used wearable inertial movement sensors to record full-day leg movement activity from 12 infants with typical development, ages 1–12 months. Each infant was tested three times across 5 months, and followed until the onset of independent walking. We developed and validated an algorithm to identify infant-produced leg movements. Results: Infants moved their legs tens of thousands of times per day. There was a significant effect of leg movement quantity on walking onset. Infants who moved their legs more walked later than infants who moved their legs less, even when adjusting for age, developmental level or percentile length. We will need a much larger sample to adequately capture and describe the effect of movement experience on developmental rate. Our algorithm defines a leg movement in a specific way (each pause or change in direction is counted as a new movement), and further assessment of movement characteristics are necessary before we can fully understand and interpret our finding that infants who moved their legs more walked later than infants who moved their legs less. Conclusions: We have shown that typically-developing infants produce thousands of leg movements in a typical day, and that this can be accurately captured in the home environment using wearable sensors. In our small sample we can identify there is an effect of leg movement quantity on walking onset, however we cannot fully explain it.
doi:10.3390/s150819006
PMCID: PMC4570357  PMID: 26247951
infant; movement; growth and development; wearable sensors
8.  Apriori feasibility testing of randomized clinical trial design in patients with cleft deformities and Class III malocclusion 
Objectives
To assess the feasibility of randomizing treatment (surgical vs. non-surgical) for correction of a Class III malocclusion (underbite) resulting from an earlier repair of cleft lip and palate.
Materials and methods
Surveys about willingness to accept randomized treatment during adolescence were mailed to the parents of cleft lip and palate patients under the care of Children's Hospital Los Angeles between 2005 and 2010. The inclusion criteria were patients with cleft lip and palate, Class III malocclusion due to maxillary deficiency, and absence of medical and cognitive contraindications to treatment.
Results
Out of 287 surveys, 82 (28%) were completed and returned; 47% of the subjects held a strong treatment preference (95% CI, 35–58%), while 30% were willing to accept randomization (95% CI, 20– 41%). Seventy-eight percent would drop out of a randomized trial if dissatisfied with the assigned treatment (95% CI, 67–86%). The three most commonly cited reasons for being unwilling to accept random treatment assignment were 1) the desire for doctors to choose the best treatment, 2) the desire for parents to have input on treatment, and 3) the desire to correct the underbite as early as possible.
Conclusion
Based on this study, parents and patients would be unwilling to accept a randomly assigned treatment and would not remain in an assigned group if treatment did not meet expectations. This highlight the limitations associated with randomization trials involving surgical modalities and provide justification for other research models (e.g., cohort studies) to compare two treatment options when randomization is not feasible.
doi:10.1016/j.ijporl.2014.01.006
PMCID: PMC4336545  PMID: 24630053
Feasibility; Randomized trial; Observational cohort study
9.  Changes in Bone Biomarkers, BMC, and Insulin Resistance Following a 10-Week Whole Body Vibration Exercise Program in Overweight Latino Boys 
Purpose: With the childhood obesity epidemic, efficient methods of exercise are sought to improve health. We tested whether whole body vibration (WBV) exercise can positively affect bone metabolism and improve insulin/glucose dynamics in sedentary overweight Latino boys. Methods: Twenty Latino boys 8-10 years of age were randomly assigned to either a control (CON) or 3 days/wk WBV exercise (VIB) for 10-wk.
Results: Significant increases in BMC (4.5±3.2%; p=0.01) and BMD (1.3±1.3%; p<0.01) were observed for the VIB group when compared to baseline values. For the CON group BMC significantly increased (2.0±2.2%; p=0.02), with no change in BMD (0.8±1.3%; p=0.11). There were no significant between group changes in BMC or BMD. No significant change was observed for osteocalcin and (collagen type I C-telopeptide) CTx for the VIB group. However, osteocalcin showed a decreasing trend (p=0.09) and CTx significantly increased (p<0.03) for the CON group. This increase in CTx was significantly different between groups (p<0.02) and the effect size of between-group difference in change was large (-1.09). There were no significant correlations between osteocalcin and measures of fat mass or insulin resistance for collapsed data.
Conclusion: Although bone metabolism was altered by WBV training, no associations were apparent between osteocalcin and insulin resistance. These findings suggest WBV exercise may positively increase BMC and BMD by decreasing bone resorption in overweight Latino boys.
doi:10.7150/ijms.11364
PMCID: PMC4466514  PMID: 26078710
prepubescent; exercise; osteocalcin; insulin sensitivity; fat mass
10.  Reliability and accuracy of digital templating for the humeral component of total shoulder arthroplasty 
Shoulder … Elbow  2014;7(1):29-35.
Background
This experimental study evaluated the interobserver reliability and accuracy of pre-operative digital templating for humeral head size, stem size and neck angle for total shoulder arthroplasty.
Methods
Twenty-five patients underwent a total shoulder arthroplasty with a single prosthesis. Four independent, blinded surgeons (two experienced shoulder surgeons and two PGY-6 fellows) used pre-operative radiographs and templating software to generate templates of the humeral head, stem and neck for each patient. Interobserver reliability was calculated using weighted kappa (κ) analysis. Accuracy was assessed by comparing templates to actual implant sizes.
Results
Interobserver reliability was fair to substantial (κ = 0.26 to 0.71) for head size, fair to substantial (κ = 0.39 to 0.72) for stem size and slight to fair (κ = 0.16 to 0.34) for neck angle. Templated head size, stem size and neck angle had accuracies of 53%, 77% and 68% within one size variation, respectively. Experience did not affect accuracy (p = 0.11 to 0.48).
Conclusions
Digital templating is not a useful guide for pre-operative surgical planning and should not be used to select a prosthesis.
doi:10.1177/1758573214550838
PMCID: PMC4935101  PMID: 27582954
Accuracy; digital templates; digital templating; interobserver reliability; prosthesis; shoulder arthroplasty
11.  Physiological and Behavioral Stress and Anxiety in Children with Autism Spectrum Disorders during Routine Oral Care 
BioMed Research International  2014;2014:694876.
Background. Children with autism spectrum disorders (ASD) commonly exhibit uncooperative behaviors which impede oral care. Previous studies have utilized dentist-report measures of uncooperative behaviors in children with ASD but none have utilized an objective measure of children's behavior or a physiological measure of distress. This study investigated behavioral and physiological distress in children with ASD during routine oral care and examined factors associated with this distress. Methods. Participants were 44 children (n = 22 typical, n = 22 ASD) aged 6–12 receiving routine dental cleanings. Behavioral and physiological measures of stress and anxiety were collected during dental cleanings. Results. Children with ASD exhibited greater distress, compared to the typical group, on dentist-report and researcher-coded measures of overt distress behaviors and on physiological measures. Correlations between physiological and behavioral measures of distress were found in the ASD but not in the typical group. Behavioral distress was correlated with age in the typical group and with expressive communication ability and sensory processing difficulties in the ASD group; physiological distress was correlated with parent-report of anxiety in the typical group and sensory processing difficulties in the ASD group. Conclusions. Novel strategies may be required to decrease behavioral and physiological distress in children with ASD in the dental clinic.
doi:10.1155/2014/694876
PMCID: PMC4119730  PMID: 25114916
12.  Imagine HEALTH: results from a randomized pilot lifestyle intervention for obese Latino adolescents using Interactive Guided ImagerySM 
Background
There is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type 2 diabetes and cardiovascular disease risk in obese Latino adolescents. Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents. Our objectives were: 1) To pilot test a new 12-wk lifestyle intervention using a randomized trial design in obese Latino adolescents, in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM (IGI), over and above those of a didactic lifestyle education, on insulin resistance, eating and physical activity behaviors, stress and stress biomarkers; and 2) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes, particularly insulin resistance.
Methods
Obese (BMI > 95th percentile), Latino adolescents (n = 35, age 14-17) were randomized to receive either 12 weekly sessions of a lifestyle education plus guided imagery program (GI), or lifestyle education plus a digital storytelling computer program (DS). Between-group differences in behavioral, biological, and psychological outcomes were assessed using unpaired T-tests and ANCOVA in the 29 subjects who completed the intervention.
Results
The GI group demonstrated significant reductions in leisure sedentary behavior (p < .05) and increases in moderate physical activity (p < .05) compared to DS group, and a trend toward reduced caloric intake in GI vs DS (p = .09). Salivary cortisol was acutely reduced by stress-reduction guided imagery (p < .01). There were no group differences in adiposity, insulin resistance, perceived stress, or stress biomarkers across the 12-week intervention, though decrease in serum cortisol over the course of the intervention was associated with improved insulin sensitivity (p = .03) independent of intervention group and other relevant co-variates.
Conclusions
The improvements in physical activity and stress biomarkers following this pilot intervention support the role of guided imagery in promoting healthy lifestyle behavior change and reducing metabolic disease risk in obese Latino adolescent populations. Future investigations will be needed to determine the full effects of the Imagine HEALTH intervention on insulin resistance, stress, and stress biomarkers.
Trial registration
Clinicaltrials.gov Registry #: NCT01895595
doi:10.1186/1472-6882-14-28
PMCID: PMC3931490  PMID: 24433565
Guided imagery; Obesity; Childhood; Latino; Adolescents; Lifestyle; Diabetes
13.  Persistence of the metabolic syndrome and its influence on carotid artery intima media thickness in overweight Latino children 
Atherosclerosis  2009;206(2):594-598.
Objective
The objective of this study was to examine the influence of persistence of the MetS (MetS) and its individual components over a 3-year period on carotid intima media thickness (CIMT) in overweight Latino children.
Methods
Ninety-seven healthy male and female overweight Latino children (mean age at baseline: 11.0±1.8 yrs) were assessed for MetS on four annual evaluations and classified according to the persistence of MetS: NEVER (0 annual visits with the MetS, n=53), INTERMITTENT (1 or 2 visits with the MetS, n=28), and PERSISTENT (3 or 4 visits with the MetS, n=16). CIMT was measured with high-resolution B-mode ultrasound (7.9±0.7 months after the most recent MetS assessment; mean age: 14.6±1.8 yr).
Results
PERSISTENT MetS was associated with significantly higher CIMT (0.647mm±0.018 compared to (0.600mm±0.007 in those who NEVER had MetS, p<0.01). This difference remained significant after controlling for gender, baseline age, total fat mass, total lean tissue mass and insulin sensitivity. PERSISTENT high waist circumference and PERSISTENT high blood pressure were also significantly associated with higher mean CIMT, but these differences were no longer significant after controlling for total fat and lean tissue mass. Baseline systolic blood pressure and 2-hour glucose were significantly related to CIMT independent of all other MetS components (p<0.05).
Conclusions
Persistence of the MetS over a 3-year period was uniquely associated with increased CIMT during childhood. Children with hypertension, persistent abdominal adiposity and impaired glucose tolerance may also be at higher risk for elevated CIMT.
doi:10.1016/j.atherosclerosis.2009.03.013
PMCID: PMC3767145  PMID: 19446812
CIMT; obesity; children; MetS
14.  Persistence of the metabolic syndrome over 3 annual visits in overweight Latino children: Association with progressive risk for type 2 diabetes 
The Journal of pediatrics  2009;155(4):535-541.
Objective
To examine whether persistent Metabolic syndrome (MetS) was associated with risk for type 2 diabetes in overweight Latino children.
Study design
73 participants (age 11.0±1.7 years) from a longitudinal study were classified as: NEVER (negative for MetS at all 3 visits); INTERMITTENT (positive for MetS at 1 or 2 visits); or PERSISTENT (positive for MetS at all 3 visits). Measures included DEXA, MRI, 2-h oral glucose tolerance test, and frequently sampled intravenous glucose tolerance test.
Results
The PERSISTENT group had a faster rate of fat mass gain than the NEVER group (20% vs. 15% gain of baseline value, p<0.05 for time*group interaction (time= visit)). Independent of body composition, the PERSISTENT group increased by 70% in insulin incremental area under the curve, and the other groups decreased (p<0.05 for time*group interaction). Despite no time*group interactions for insulin sensitivity, acute insulin response, or disposition index, the PERSISTENT maintained 43% lower insulin sensitivity (p<0.01) and by visit 2 had a 25% lower disposition index (p<0.05) compared with the NEVER group.
Conclusion
Participants with persistent MetS had accelerated fat gain, increasing insulin response to oral glucose, and lower insulin sensitivity and beta cell function, indicators of progressively greater risk for type 2 diabetes.
doi:10.1016/j.jpeds.2009.04.008
PMCID: PMC3709847  PMID: 19555970
longitudinal; beta cell function; insulin sensitivity; insulin resistance; insulin IAUC
15.  Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol 
BMC Neurology  2013;13:5.
Background
Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.
The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC.
Methods/design
Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.
The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05.
Discussion
ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose.
Trial registration
http://www.ClinicalTrials.gov Identifier: NCT00871715
doi:10.1186/1471-2377-13-5
PMCID: PMC3547701  PMID: 23311856
Stroke; Brain infarction; Hemiparesis; Neurorehabilitation; Task-specific training; Motor recovery; Occupational therapy; Physical therapy
16.  Randomized Controlled Trial to Improve Adiposity, Inflammation, and Insulin Resistance in Obese African-American and Latino Youth 
Obesity (Silver Spring, Md.)  2011;20(4):811-818.
The purpose of this study was to examine ethnic differences in the metabolic responses to a 16-week intervention designed to improve insulin sensitivity (SI), adiposity, and inflammation in obese African-American and Latino adolescents. A total of 100 participants (African Americans: n = 48, Latino: n = 52; age: 15.4 ± 1.1 years, BMI percentile: 97.3 ± 3.3) were randomly assigned to interventions: control (C; n = 30), nutrition (N; n = 39, 1×/week focused on decreasing sugar and increasing fiber intake), or nutrition + strength training (N+ST; n = 31, 2×/week). The following were measured at pre- and postintervention: strength, dietary intake, body composition (dual-energy X-ray absorptiometry/magnetic resonance imaging) and glucose/insulin indexes (oral glucose tolerance test (OGTT)/intravenous glucose tolerance test (IVGTT)) and inflammatory markers. Overall, N compared to C and N+ST reported significant improvements in SI (+16.5% vs. −32.3% vs. −6.9% respectively, P < 0.01) and disposition index (DI: +15.5% vs. −14.2% vs. −13.7% respectively, P < 0.01). N+ST compared to C and N reported significant reductions in hepatic fat fraction (HFF: −27.3% vs. −4.3% vs. 0% respectively, P < 0.01). Compared to N, N+ST reported reductions in plasminogen activator inhibitor-1 (PAI-1) (−38.3% vs. +1.0%, P < 0.01) and resistin (−18.7% vs. +11.3%, P = 0.02). There were no intervention effects for all other measures of adiposity or inflammation. Significant intervention by ethnicity interactions were found for African Americans in the N group who reported increases in total fat mass, 2-h glucose and glucose incremental areas under the curve (IAUC) compared to Latinos (P’s < 0.05). These interventions yielded differential effects with N reporting favorable improvements in SI and DI and N+ST reporting marked reductions in HFF and inflammation. Both ethnic groups had significant improvements in metabolic health; however some improvements were not seen in African Americans.
doi:10.1038/oby.2010.343
PMCID: PMC3106142  PMID: 21293446
17.  Fasting Indicators of Insulin Sensitivity: Effects of Ethnicity and Pubertal Status 
Diabetes Care  2011;34(4):994-999.
OBJECTIVE
To examine the relationship of fasting indicators of insulin sensitivity with a more invasive measure of insulin sensitivity (frequently sampled intravenous glucose tolerance test [FSIVGTT]) and the effect of Tanner stage and ethnicity on that relationship.
RESEARCH DESIGN AND METHODS
Data were analyzed from 149 overweight girls (97 Hispanic and 52 African American) who were either in the early stages of maturation defined by Tanner stages 1 or 2 (52 Hispanic and 18 African American) or in the later stages of maturation defined by Tanner stages 4 and 5 (45 Hispanic and 34 African American). Fasting indicators of insulin sensitivity (IS) included fasting insulin and glucose and the homeostasis model assessment of insulin resistance (HOMA-IR). IS was derived from an FSIVGTT with minimal modeling.
RESULTS
In Tanner stages 1 and 2, all fasting indicators were significantly associated with IS: (fasting insulin: r = −0.67, P < 0.01; HOMA: r = −0.66, P < 0.01) with no significant influence of ethnicity on these relationships. In Tanner stages 4 and 5, however, all fasting indicators were associated with IS in African American girls (fasting insulin: r = −0.55, P < 0.01; HOMA: r = −0.47, P < 0.01), but none of the indicators were significantly associated with IS in Hispanic girls.
CONCLUSIONS
Fasting indicators were reflective of IS for girls in Tanner stages 1 and 2, regardless of ethnicity and may provide a clinical measure of future risk for type 2 diabetes. In the latter stages of maturation, however, more invasive measures are warranted to adequately determine IS in clinical practice.
doi:10.2337/dc10-1593
PMCID: PMC3064063  PMID: 21357795
18.  Pubertal Changes of Insulin Sensitivity, Acute Insulin Response and β-Cell function in Overweight Latino Youth 
The Journal of pediatrics  2011;158(3):442-446.
Objective
To examine changes in insulin sensitivity (SI), compensatory acute insulin response (AIR) and β-cell function/disposition index (DI) across puberty in overweight Latino boys and girls.
Study design
253 Latino children followed annually for up to 5 years. Longitudinal modeling was used to examine changes in SI, AIR, DI and fasting and 2-hr glucose and insulin across Tanner stage.
Results
In boys, SI decreased in early puberty with a recovery by late puberty. The compensatory increase in AIR was appropriate in early maturation, but after Tanner 3, AIR declined by more than that predicted from the recovery in SI. For girls, SI decreased in early puberty and across all stages of maturation. In early maturation, there was an appropriate compensatory increase in AIR, but after Tanner 3 AIR decreased. Thus, DI deteriorated across puberty in boys and girls.
Conclusions
In overweight Hispanic youth, compensatory changes in insulin secretion fails after Tanner 3 in both sexes, indicating β-cell deterioration during this critical period of development, thus increasing risk for Type 2 diabetes.
doi:10.1016/j.jpeds.2010.08.046
PMCID: PMC3039101  PMID: 20888012
Insulin resistance; Beta cell function; puberty; longitudinal; Latino
19.  CRP Is Related to Higher Leptin Levels in Minority Peripubertal Females Regardless of Adiposity Levels 
Obesity (Silver Spring, Md.)  2011;20(3):512-516.
Overweight is related to higher levels of C-reactive protein (CRP) and leptin, which have been independently associated with increased risk for diabetes, cardiovascular disease, and the metabolic syndrome. Elevated CRP may trigger leptin resistance by inhibiting the binding of leptin to its receptors. We cross-sectionally examined the relationship between CRP, leptin, BMI z-score, percent body fat (%BF) assessed by air plethysmography (BodPod), and insulin sensitivity (SI) and acute insulin response (AIRg) measured by intravenous glucose tolerance test in 51 Latina and African-American females (77% Latina), mean age 9.2 (±0.9) years, at either Tanner Pubertal Stage (TPS) 1 (n = 25) or TPS 2 (n = 26). Females at TPS 2 had higher BMI z-scores, %BF (23% ± 10.1 vs. 30% ± 10.0, P = 0.02), AIRg (976.7 ± 735.2 vs. 1555.3 ± 1,223 µIU/ml, P = 0.05), fasting insulin (11.0 ± 10.8 vs. 17.2 ± 13.6 µlU/ml, P = 0.00) and leptin levels (11.0 ± 7.1 vs. 19.6 ± 10.9 ng/ml, P < 0.001) than those at TPS 1. There were no ethnic differences in any of the measured variables. CRP was positively correlated with BMI z-score (P = 0.001), %BF (P = 0.006), fasting insulin and AIRg (P = 0.02), and fasting leptin (P = 0.00), and negatively correlated with SI (P = 0.05). A linear regression model showed that CRP independently explained 10% (P = 0.00) of the variance in leptin after adjusting %BF, TPS, ethnicity, habitual physical activity and SI. Hence, low-grade inflammation may contribute to prolonged leptin exposure and leptin resistance, even in healthy children.
doi:10.1038/oby.2011.49
PMCID: PMC3200494  PMID: 21436796
20.  Insulin Sensitivity as an Independent Predictor of Fat Mass Gain in Hispanic Adolescents 
Diabetes Care  2009;32(11):2114-2115.
OBJECTIVE
The purpose of this study was to examine the relationship between changes in insulin sensitivity and subsequent changes in fat mass in obese Hispanic children over 3 consecutive years.
RESEARCH DESIGN AND METHODS
In a longitudinal research design, insulin sensitivity (Si) of 96 research participants was determined at baseline and 1 year later. Body adiposity was assessed at four assessments.
RESULTS
The change in Si during the first year of the study was a significant predictor of further fat mass development (P < 0.05). Considering different directions of Si change, Si was a strong predictor for further fat mass development only in the group that decreased their Si (P < 0.05).
CONCLUSIONS
The results show that the direction of change in insulin sensitivity at an early age is an important independent predictor for further fat mass development and emphasize the importance of insulin sensitivity as a primary target for long-term obesity prevention, as well as the significance of early age intervention.
doi:10.2337/dc09-0833
PMCID: PMC2768217  PMID: 19675204
21.  Dietary Intake and the Metabolic Syndrome in Overweight Latino Children 
Little is known about the relationship between diet and metabolic health in Latino children, a population at increased risk for diabetes. The present study evaluates diet composition and the metabolic syndrome in a cross-sectional sample of 109 overweight Latino children aged 10 to 17 years with a family history of type 2 diabetes. Dietary intake was assessed by two 24-hour recalls. Associations between nutrients and features of the metabolic syndrome were examined using multiple linear regression and analysis of covariance. Log cholesterol intake was positively associated with log systolic blood pressure (β=0.034, P=0.017) and log soluble dietary fiber intake was inversely associated with log waist circumference (β=−0.069, P=0.036). Log soluble fiber intake was significantly higher in participants with 0 features compared to those with 3+ features of the metabolic syndrome (P=0.046), which translates to 5.2 g vs 4.1 g soluble fiber daily. No other significant associations were found between dietary variables and either the individual features of the metabolic syndrome or the clustering of metabolic syndrome components. Increases in soluble fiber through the daily consumption of fruits, vegetables, and beans may improve metabolic health in Latino children.
doi:10.1016/j.jada.2008.05.006
PMCID: PMC2882193  PMID: 18656576
22.  Randomized Control Trial to Improve Adiposity and Insulin Resistance in Overweight Latino Adolescents 
Obesity (Silver Spring, Md.)  2009;17(8):1542-1548.
Few randomized trials attempt to improve insulin sensitivity and associated metabolic risks in overweight Latino youth. The purpose of this study is to examine the effects of a modified carbohydrate nutrition program combined with strength training on insulin sensitivity, adiposity, and other type 2 diabetes risk factors in overweight Latino adolescents. In a 16-week randomized trial, 54 overweight Latino adolescents (15.5 ± 1.0 years) were randomly assigned to: (i) Control (C; n = 16), (ii) Nutrition (N; n = 21), or (iii) Nutrition + Strength training (N+ST; n = 17). The N group received modified carbohydrate nutrition classes (once per week), while the N+ST received the same nutrition classes plus strength training (twice per week). The following were measured at pre- and postintervention: strength by 1-repetition maximum, dietary intake by 3-day records, body composition by dual-energy X-ray absorptiometry, glucose/insulin indices by oral glucose tolerance test (OGTT) and intravenous glucose tolerance test with minimal modeling. Across intervention group effects were tested using analysis of covariance with post hoc pairwise comparisons. A significant overall intervention effect was found for improvement in bench press (P < 0.001) and reductions in energy (P = 0.05), carbohydrate (P = 0.04) and fat intake (P = 0.03). There were no significant intervention effects on insulin sensitivity, body composition, or most glucose/insulin indices with the exception of glucose incremental area under the curve (IAUC) (P = 0.05), which decreased in the N and N+ST group by 18 and 6.3% compared to a 32% increase in the C group. In conclusion, this intense, culturally tailored intervention resulted in no significant intervention effects on measured risk factors with the exception of a beneficial effect on glycemic response to oral glucose.
doi:10.1038/oby.2009.19
PMCID: PMC2846423  PMID: 19247280
23.  Aerobic and Strength Training Reduces Adiposity in Overweight Latina Adolescents 
Purpose
To date, no study has examined the synergistic effects of a nutrition and combination of aerobic and strength training (CAST) on both adiposity and metabolic parameters in overweight Latina adolescent females. The goal was to assess if a 16-wk nutrition plus CAST pilot study had stronger effects on reducing adiposity and on improving glucose/insulin indices compared with control (C), nutrition only (N), and a nutrition plus strength training (N + ST) groups.
Methods
In a 16-wk randomized trial, 41 overweight Latina girls (15.2 ± 1.1 yr) were randomly assigned to C (n = 7), N (n = 10), N + ST (n = 9), or N + CAST (n = 15). All intervention groups received modified carbohydrate nutrition classes (once a week), whereas the N + ST also received strength training (twice a week) and the N + CAST received a combination of strength and aerobic training (twice a week). The following were measured before and after intervention: strength by one repetition maximum, physical activity by the 7-d accelerometry and the 3-d physical activity recall, dietary intake by 3-d records, body composition by dual-energy x-ray absorptiometry (DEXA), glucose/insulin indices by oral glucose tolerance test, and intravenous glucose tolerance test with minimal modeling. Across intervention group, effects were tested using ANCOVA with post hoc pairwise comparisons.
Results
There were significant overall intervention effects for all adiposity measures (weight, body mass index [BMI], BMI z-scores, and DEXA total body fat), with a decrease of 3% in the N + CAST group compared with a 3% increase in the N + ST group (P ≤ 0.05). There was also an intervention effect for fasting glucose with the N group increasing by 3% and the N + CAST group decreasing by 4% (P ≤ 0.05).
Conclusion
The CAST was more effective than nutrition alone or nutrition plus strength training for reducing multiple adiposity outcomes and fasting glucose in overweight Latina girls. However, further research investigating and identifying intervention approaches that improve both adiposity and insulin indices, particularly in high-risk populations, are warranted.
doi:10.1249/MSS.0b013e31819b6aea
PMCID: PMC2836768  PMID: 19516150
EXERCISE; NUTRITION; INTERVENTION; OVERWEIGHT; TEENAGERS
24.  Cardiorespiratory fitness predicts changes in adiposity in overweight Hispanic boys 
Obesity (Silver Spring, Md.)  2008;16(5):1072-1077.
We have previously shown that cardiorespiratory fitness predicts increasing fat mass during growth in white and African-American youth, but limited data are available examining this issue in Hispanic youth. Study participants were 160 (53% boys) overweight (BMI ≥ 85th percentile for age and gender) Hispanic children (mean ± SD age at baseline =11.2 ± 1.7 yrs). Cardiorespiratory fitness, or VO2max, was measured via a maximal effort treadmill test at baseline. Body composition by dual-energy x-ray absorptiometry and Tanner stage by clinical exam were measured at baseline and annually thereafter for up to four years. Linear mixed models were used to examine the gender specific relationship between VO2max and increases in adiposity (change in fat mass independent of change in lean tissue mass) over four years. The analysis was adjusted for changes in Tanner stage, age, and lean tissue mass. In boys, higher VO2max at baseline was inversely associated with the rate of increase in adiposity (β= -0.001, p=0.03); this effect translates to a 15% higher VO2max at baseline resulting in a 1.38kg lower fat mass gain over four years. However, VO2max was not significantly associated with changes in fat mass in girls (β=0.0002, p=0.31). In overweight Hispanic boys, greater cardiorespiratory fitness at baseline was protective against increasing adiposity. In girls however, initial cardiorespiratory fitness was not significantly associated with longitudinal changes in adiposity. These results suggest that fitness may be an important determinant of changes in adiposity in overweight Hispanic boys but not in girls.
doi:10.1038/oby.2008.16
PMCID: PMC2780237  PMID: 18309303
Children; Youth; Longitudinal; Gender

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