Steven Cen

Body-weight-supported treadmill rehabilitation after stroke.

BACKGROUND Locomotor training, including the use of body-weight support in treadmill stepping, is a physical therapy intervention used to improve recovery of the ability to walk after stroke. The effectiveness and appropriate timing of this intervention have not been established. METHODS We stratified 408 participants who had had a stroke 2 months earlier according to the extent of walking impairment--moderate (able to walk 0.4 to <0.8 m per second) or severe (able to walk <0.4 m per second)--and randomly assigned them to one of three training groups. One group received training on a treadmill with the use of body-weight support 2 months after the stroke had occurred (early locomotor training), the second group received this training 6 months after the stroke had occurred (late locomotor training), and the third group participated in an exercise program at home managed by a physical therapist 2 months after the stroke (home-exercise program). Each intervention included 36 sessions of 90 minutes each for 12 to 16 weeks. The primary outcome was the proportion of participants in each group who had an improvement in functional walking ability 1 year after the stroke. RESULTS At 1 year, 52.0% of all participants had increased functional walking ability. No significant differences in improvement were found between early locomotor training and home exercise (adjusted odds ratio for the primary outcome, 0.83; 95% confidence interval [CI], 0.50 to 1.39) or between late locomotor training and home exercise (adjusted odds ratio, 1.19; 95% CI, 0.72 to 1.99). All groups had similar improvements in walking speed, motor recovery, balance, functional status, and quality of life. Neither the delay in initiating the late locomotor training nor the severity of the initial impairment affected the outcome at 1 year. Ten related serious adverse events were reported (occurring in 2.2% of participants undergoing early locomotor training, 3.5% of those undergoing late locomotor training, and 1.6% of those engaging in home exercise). As compared with the home-exercise group, each of the groups receiving locomotor training had a higher frequency of dizziness or faintness during treatment (P=0.008). Among patients with severe walking impairment, multiple falls were more common in the group receiving early locomotor training than in the other two groups (P=0.02). CONCLUSIONS Locomotor training, including the use of body-weight support in stepping on a treadmill, was not shown to be superior to progressive exercise at home managed by a physical therapist. (Funded by the National Institute of Neurological Disorders and Stroke and the National Center for Medical Rehabilitation Research; LEAPS ClinicalTrials.gov number, NCT00243919.).

Meaningful Gait Speed Improvement During the First 60 Days Poststroke: Minimal Clinically Important Difference

Background When people with stroke recover gait speed, they report improved function and reduced disability. However, the minimal amount of change in gait speed that is clinically meaningful and associated with an important difference in function for people poststroke has not been determined. Objective The purpose of this study was to determine the minimal clinically important difference (MCID) for comfortable gait speed (CGS) associated with an improvement in the modified Rankin Scale (mRS) score for people between 20 to 60 days poststroke. Design This was a prospective, longitudinal, cohort study. Methods The participants in this study were 283 people with first-time stroke prospectively enrolled in the ongoing Locomotor Experience Applied Post Stroke (LEAPS) multi-site randomized clinical trial. Comfortable gait speed was measured and mRS scores were obtained at 20 and 60 days poststroke. Improvement of ≥1 on the mRS was used to detect meaningful change in disability level. Results Mean (SD) CGS was 0.18 (0.16) m/s at 20 days and 0.39 (0.22) m/s at 60 days poststroke. Among all participants, 47.3% experienced an improvement in disability level ≥1. The MCID was estimated as an improvement in CGS of 0.16 m/s anchored to the mRS. Limitations Because the mRS is not a gait-specific measure of disability, the estimated MCID for CGS was only 73.9% sensitive and 57.0% specific for detecting improvement in mRS scores. Conclusions We estimate that the MCID for gait speed among patients with subacute stroke and severe gait speed impairments is 0.16 m/s. Patients with subacute stroke who increase gait speed ≥0.16 m/s are more likely to experience a meaningful improvement in disability level than those who do not. Clinicians can use this reference value to develop goals and interpret progress in patients with subacute stroke.

Motor Cortex Activation During Treatment May Predict Therapeutic Gains in Paretic Hand Function After Stroke

Background and Purpose— Functional brain imaging after stroke offers insight into motor network adaptations. This exploratory study examined whether motor cortical activation captured during arm-focused therapy can predict paretic hand functional gains. Methods— Eight hemiparetic patients had serial functional MRI (fMRI) while performing a pinch task before, midway, and after 2 weeks of constraint-induced therapy. The Wolf Motor Function Test (WMFT) was performed before and after intervention. Results— There was a linear reduction in ipsilateral (contralesional) primary motor (M1) activation (voxel counts) across time. The midpoint M1 Laterality Index anticipated post-therapeutic change in time to perform the WMFT. The change in ipsilateral M1 voxel count (pre- to mid-) correlated with the change in mean WMFT time (pre- to post-). Conclusions— The relationship between brain activation during treatment and functional gains suggests a use for serial fMRI in predicting the success and optimal duration for a focused therapeutic intervention.

Fugl-Meyer Assessment of Sensorimotor Function After Stroke Standardized Training Procedure for Clinical Practice and Clinical Trials

Background and Purpose— Outcome measurement fidelity within and between sites of multi-site, randomized, clinical trials is an essential element to meaningful trial outcomes. As important are the methods developed for randomized, clinical trials that can have practical utility for clinical practice. A standardized measurement method and rater training program were developed for the total Fugl-Meyer motor and sensory assessments; inter-rater reliability was used to test program effectiveness. Methods— Fifteen individuals with hemiparetic stroke, 17 trained physical therapists across 5 regional clinical sites, and an expert rater participated in an inter-rater reliability study of the Fugl-Meyer motor (total, upper extremity, and lower extremity subscores) and sensory (total, light touch, and proprioception subscores) assessments. Results— Intra-rater reliability for the expert rater was high for the motor and sensory scores (range, 0.95–1.0). Inter-rater agreement (intraclass correlation coefficient, 2, 1) between expert and therapist raters was high for the motor scores (total, 0.98; upper extremity, 0.99; lower extremity, 0.91) and sensory scores (total, 0.93; light touch, 0.87; proprioception, 0.96). Conclusions— Standardized measurement methods and training of therapist assessors for a multi-site, rehabilitation, randomized, clinical trial resulted in high inter-rater reliability for the Fugl-Meyer motor and sensory assessments. Poststroke sensorimotor impairment severity can be reliably assessed for clinical practice or rehabilitation research with these methods.

Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial

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.

No News is Bad News: Characteristics of Adolescents Who Provide Neither Parental Consent Nor Refusal for Participation in School-Based Survey Research

Schools offer a convenient setting for research on adolescents.However, obtainingactive written parental consent is difficult. In a 6th-grade smoking study, students were recruited with two consent procedures: active consent (parents must provide written consent for their children to participate) and implied consent (children may participate unless their parents provide written refusal). Of 4,427 invited students, 3,358 (76%) provided active parental consent, 420 (9%) provided active parental refusal, and 649 (15%) provided implied consent (parental nonresponse). The implied consent procedure recruited more boys, African Americans, students with poor grades, and smokers. This dual-consentprocedure is useful for collecting some limited data from students who do not provide active consent or refusal.Schools offer a convenient setting for research on adolescents. However, obtaining active written parental consent is difficult. In a 6th-grade smoking study, students were recruited with two consent procedures: active consent (parents must provide written consent for their children to participate) and implied consent (children may participate unless their parents provide written refusal). Of 4,427 invited students, 3,358 (76%) provided active parental consent, 420 (9%) provided active parental refusal, and 649 (15%) provided implied consent (parental nonresponse). The implied consent procedure recruited more boys, African Americans, students with poor grades, and smokers. This dual-consent procedure is useful for collecting some limited data from students who do not provide active consent or refusal.

Characterizing and Identifying Risk for Falls in the LEAPS Study A Randomized Clinical Trial of Interventions to Improve Walking Poststroke

Background and Purpose— Better understanding of fall risk poststroke is required for developing screening and prevention programs. This study characterizes falls in the Locomotor Experience Applied Post-Stroke (LEAPS) randomized clinical trial, describes the impact of 2 walking recovery interventions on falls, and examines the value of clinical assessments for predicting falls. Methods— Community-dwelling ambulatory stroke survivors enrolled in LEAPS were assessed 2 months poststroke. Falls were monitored until 12 months poststroke and participants were characterized as multiple or injurious (M/I); single, noninjurious; or nonfallers. Incidence and time to M/I falls were compared across interventions (home exercise and locomotor training initiated 2 months [early-LTP] or 6 months [late-LTP] poststroke). Predictive value of 2-month clinical assessments for falls outcome was assessed. Results— Among the 408 participants, 36.0% were M/I, 21.6% were single, noninjurious, and 42.4% were nonfallers. Most falls occurred at home in the first 3 months after assessment. Falls incidence was highest for those with severe walking impairment who received early-LTP (P=0.025). Berg Balance Scale score ⩽42/56 was the single best predictor of M/I falls. Conclusions— As individuals with stroke improve in walking capacity, risk for M/I falls remains high. Individuals walking <0.4 m/s are at higher risk for M/I falls if they receive early-LTP training. Berg Balance Scale score at 2 months poststroke is useful for informing falls risk, but it cannot account for the multifactorial nature of the problem. Falls prevention in stroke will require multifactorial risk assessment and management provided concomitantly with exercise interventions to improve mobility. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00243919.

Longitudinal Effects of Hostility, Depression, and Bullying on Adolescent Smoking Initiation

PURPOSE The present study examined the associations between smoking initiation and, hostility, depressive symptoms, and bullying (bullies and bully-victims) among a culturally diverse sample of 1,771 adolescents who reported never having smoked at baseline. METHODS Data were obtained from a longitudinal school-based experimental trial of smoking prevention programs in Southern California. Annual survey was performed for students of the sixth, seventh, and eighth grades. All students in the 24 participating schools were invited to participate in the study during the sixth grade. RESULTS The risk of smoking initiation was significantly higher among students who scored higher on hostility and depressive symptoms, and were bully-victims. CONCLUSION The findings suggest that tobacco prevention programs should include strategies for managing hostile feelings and negative effect as part of the curriculum. In addition, it might be helpful to identify youth who score high on these psychosocial factors and teach them skills to handle interpersonal conflict and negative feelings to prevent their involvement in substance use.

Incidence of "never events" among weekend admissions versus weekday admissions to US hospitals: national analysis.

Objective To evaluate the association between weekend admission to hospital and 11 hospital acquired conditions recently considered by the Centers for Medicare and Medicaid as “never events” for which resulting healthcare costs are not reimbursed. Design National analysis. Setting US Nationwide Inpatient Sample discharge database. Participants 351 million patients discharged from US hospitals, 2002-10. Main outcome measures Univariate rates and multivariable likelihood of hospital acquired conditions among patients admitted on weekdays versus weekends, as well as the impacts of these events on prolonged length of stay and total inpatient charges. Results From 2002 to 2010, 351 170 803 patients were admitted to hospital, with 19% admitted on a weekend. Hospital acquired conditions occurred at an overall frequency of 4.1% (5.7% among weekend admissions versus 3.7% among weekday admissions). Adjusting for patient and hospital cofactors the probability of having one or more hospital acquired conditions was more than 20% higher in weekend admissions compared with weekday admissions (odds ratio 1.25, 95% confidence interval 1.24 to 1.26, P<0.01). Hospital acquired conditions have a negative impact on both hospital charges and length of stay. At least one hospital acquired condition was associated with an 83% (1.83, 1.77 to 1.90, P<0.01) likelihood of increased charges and 38% likelihood of prolonged length of stay (1.38, 1.36 to 1.41, P<0.01). Conclusion Weekend admission to hospital is associated with an increased likelihood of hospital acquired condition, cost, and length of stay. Future protocols and staffing regulations must be tailored to the requirements of this high risk subgroup.

Effects of Task-Specific and Impairment-Based Training Compared With Usual Care on Functional Walking Ability After Inpatient Stroke Rehabilitation LEAPS Trial

Background. After inpatient stroke rehabilitation, many people still cannot participate in community activities because of limited walking ability. Objective. To compare the effectiveness of 2 conceptually different, early physical therapy (PT) interventions to usual care (UC) in improving walking 6 months after stroke. Methods. The Locomotor Experience Applied Post-Stroke (LEAPS) study was a single-blind, randomized controlled trial conducted in 408 adults with disabling hemiparetic stroke. Participants were stratified at baseline (2 months) by impairment in walking speed: severe (<0.4 m/s) or moderate (0.4 to <0.8 m/s). Between 2 and 6 months, they received either only UC (n = 143) or UC plus 36 therapist-provided sessions of either (1) walking training on a treadmill using body-weight support and practice overground at clinics (locomotor training program [LTP], n = 139) or (2) impairment-based strength and balance exercise at home (home exercise program [HEP], n = 126). Results. LTP participants were 18% more likely to transition to a higher functional walking level: severe to >0.4 m/s and moderate to >0.8 m/s than UC participants (95% confidence interval [CI] = 7%-29%), and HEP participants were 17% more likely to transition (95% CI = 5%-29%). Mean gain in walking speed in LTP participants was 0.13 m/s greater (95% CI = 0.09-0.18) and in HEP participants, 0.10 m/s greater (95% CI = 0.05-0.14) than in UC participants. Conclusions. Progressive PT, using either walking training on a treadmill and overground, conducted in a clinic, or strength and balance exercises conducted at home, was superior to UC in improving walking, regardless of severity of initial impairment.