Julie K. Tilson

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.

Taking healthcare interventions from trial to practice

The results of thousands of trials are never acted on because their published reports do not describe the interventions in enough detail. How can we improve the reporting?

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial

BackgroundLocomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention.The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions.Methods/DesignWe will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks.Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment.LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean difference in gait speed change between the two LTP groups.DiscussionThe goal of this single-blinded, phase III randomized clinical trial is to provide evidence to guide post-stroke walking recovery programs.Trial registrationNCT00243919.

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.

Sicily statement on classification and development of evidence-based practice learning assessment tools

BackgroundTeaching the steps of evidence-based practice (EBP) has become standard curriculum for health professions at both student and professional levels. Determining the best methods for evaluating EBP learning is hampered by a dearth of valid and practical assessment tools and by the absence of guidelines for classifying the purpose of those that exist. Conceived and developed by delegates of the Fifth International Conference of Evidence-Based Health Care Teachers and Developers, the aim of this statement is to provide guidance for purposeful classification and development of tools to assess EBP learning.DiscussionThis paper identifies key principles for designing EBP learning assessment tools, recommends a common taxonomy for new and existing tools, and presents the Classification Rubric for EBP Assessment Tools in Education (CREATE) framework for classifying such tools. Recommendations are provided for developers of EBP learning assessments and priorities are suggested for the types of assessments that are needed. Examples place existing EBP assessments into the CREATE framework to demonstrate how a common taxonomy might facilitate purposeful development and use of EBP learning assessment tools.SummaryThe widespread adoption of EBP into professional education requires valid and reliable measures of learning. Limited tools exist with established psychometrics. This international consensus statement strives to provide direction for developers of new EBP learning assessment tools and a framework for classifying the purposes of such tools.

Evidence of effectiveness of health care professionals using handheld computers : a scoping review of systematic reviews

Background Handheld computers and mobile devices provide instant access to vast amounts and types of useful information for health care professionals. Their reduced size and increased processing speed has led to rapid adoption in health care. Thus, it is important to identify whether handheld computers are actually effective in clinical practice. Objective A scoping review of systematic reviews was designed to provide a quick overview of the documented evidence of effectiveness for health care professionals using handheld computers in their clinical work. Methods A detailed search, sensitive for systematic reviews was applied for Cochrane, Medline, EMBASE, PsycINFO, Allied and Complementary Medicine Database (AMED), Global Health, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. All outcomes that demonstrated effectiveness in clinical practice were included. Classroom learning and patient use of handheld computers were excluded. Quality was assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. A previously published conceptual framework was used as the basis for dual data extraction. Reported outcomes were summarized according to the primary function of the handheld computer. Results Five systematic reviews met the inclusion and quality criteria. Together, they reviewed 138 unique primary studies. Most reviewed descriptive intervention studies, where physicians, pharmacists, or medical students used personal digital assistants. Effectiveness was demonstrated across four distinct functions of handheld computers: patient documentation, patient care, information seeking, and professional work patterns. Within each of these functions, a range of positive outcomes were reported using both objective and self-report measures. The use of handheld computers improved patient documentation through more complete recording, fewer documentation errors, and increased efficiency. Handheld computers provided easy access to clinical decision support systems and patient management systems, which improved decision making for patient care. Handheld computers saved time and gave earlier access to new information. There were also reports that handheld computers enhanced work patterns and efficiency. Conclusions This scoping review summarizes the secondary evidence for effectiveness of handheld computers and mhealth. It provides a snapshot of effective use by health care professionals across four key functions. We identified evidence to suggest that handheld computers provide easy and timely access to information and enable accurate and complete documentation. Further, they can give health care professionals instant access to evidence-based decision support and patient management systems to improve clinical decision making. Finally, there is evidence that handheld computers allow health professionals to be more efficient in their work practices. It is anticipated that this evidence will guide clinicians and managers in implementing handheld computers in clinical practice and in designing future research.

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.

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.

Use of handheld computers in clinical practice: a systematic review

BackgroundMany healthcare professionals use smartphones and tablets to inform patient care. Contemporary research suggests that handheld computers may support aspects of clinical diagnosis and management. This systematic review was designed to synthesise high quality evidence to answer the question; Does healthcare professionals’ use of handheld computers improve their access to information and support clinical decision making at the point of care?MethodsA detailed search was conducted using Cochrane, MEDLINE, EMBASE, PsycINFO, Science and Social Science Citation Indices since 2001. Interventions promoting healthcare professionals seeking information or making clinical decisions using handheld computers were included. Classroom learning and the use of laptop computers were excluded. Two authors independently selected studies, assessed quality using the Cochrane Risk of Bias tool and extracted data. High levels of data heterogeneity negated statistical synthesis. Instead, evidence for effectiveness was summarised narratively, according to each study’s aim for assessing the impact of handheld computer use.ResultsWe included seven randomised trials investigating medical or nursing staffs’ use of Personal Digital Assistants. Effectiveness was demonstrated across three distinct functions that emerged from the data: accessing information for clinical knowledge, adherence to guidelines and diagnostic decision making. When healthcare professionals used handheld computers to access clinical information, their knowledge improved significantly more than peers who used paper resources. When clinical guideline recommendations were presented on handheld computers, clinicians made significantly safer prescribing decisions and adhered more closely to recommendations than peers using paper resources. Finally, healthcare professionals made significantly more appropriate diagnostic decisions using clinical decision making tools on handheld computers compared to colleagues who did not have access to these tools. For these clinical decisions, the numbers need to test/screen were all less than 11.ConclusionHealthcare professionals’ use of handheld computers may improve their information seeking, adherence to guidelines and clinical decision making. Handheld computers can provide real time access to and analysis of clinical information. The integration of clinical decision support systems within handheld computers offers clinicians the highest level of synthesised evidence at the point of care. Future research is needed to replicate these early results and to identify beneficial clinical outcomes.