Early Rehabilitation Trial Research Articles

Power Analysis for Ordinal Analyses of the Modified Rankin Scale and an Online and Downloadable Tool for Practical Use.

Several methods for conducting power analysis of studies with outcomes across the full ordinal modified Rankin Scale are proposed in the literature. No systematic comparison of accuracy, agreement, and sensitivity to small changes in hypothesized effect sizes for these methods is available. Our aim is to conduct such a systematic comparative analysis and to introduce a comprehensive freely available online tool to facilitate appropriate power analyses for ordinal outcomes. We performed simulation studies utilizing the control arm modified Rankin Scale distributions from the AVERT (A Very Early Rehabilitation Trial), EXTEND (Extending the Time for Thrombolysis in Emergency Neurological Deficits), and HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) studies, as well as a uniform distribution, in combination with hypothetical treatment effects. We systematically evaluated published power formulas for Ordinal Logistic Regression and Tournament Methods (generalized odds ratio; Win Probability; Win Ratio; and Wilcoxon-Mann-Whitney U test). We also developed an online and downloadable Shiny R app facilitating sample size calculation for, and ordinal analysis of, modified Rankin Scale data. Power formulas for Tournament Methods performed well, while the formula for ordinal logistic regression was inaccurate. Tang's Wilcoxon-Mann-Whitney U test sample size formula exhibited the highest accuracy. All methods, including ordinal logistic regression, had almost identical empirical power for a given sample size. All power methods exhibited sensitivity to small changes in hypothesized effect size. The developed freely available online app supports analytical and visualization requirements for all investigated methods for power and statistical analyses of ordinal modified Rankin Scale outcomes. As Tournament Method sample size formulas are assumption-free and accurately calculate power, stroke researchers should use these methods when designing studies with outcomes measured on the full or partially collapsed modified Rankin Scale as well as other ordinal scales, even if they intend to use ordinal logistic regression for analysis. Conducting sensitivity analyses of the effect size assumptions are essential for appropriate sample size estimation. Our developed tool supports both of these recommendations (https://www.thembc.com.au/tournamentmethods).

Results from phase one of an early intervention vocational rehabilitation trial for people with spinal cord injury conducted in Queensland, Australia

BACKGROUND: The Back2Work Early Intervention Vocational Rehabilitation (EIVR) program was developed in response to the low employment rate of people with spinal cord injuries (SCI) and their lack of access to early, specialised vocational rehabilitation (VR). The program has been delivered by qualified rehabilitation counsellors to hospital patients with newly acquired SCI since 2016. OBJECTIVE: The objective of the study was to evaluate the effectiveness and consumer perspective of the Back2Work EIVR program. METHODS: The program was evaluated using a mixed-methods, longitudinal, prospective design. RESULTS: Data analysis revealed a return to work rate (RTW) of 43% by 12 months post-discharge. Qualitative data indicated positive participant experiences with the program, emphasising the hopefulness brought about by early vocational support. CONCLUSIONS: The Back2Work program has a positive impact on participants’ RTW outcomes, through the provision of early specialist vocational rehabilitation interventions. This includes building a positive culture around RTW after SCI and engagement with employers to maximise the likelihood of timely and sustainable re-employment. The RTW outcomes and emergent themes will help inform service development in the field of early vocational rehabilitation after SCI.

Can Early Neuromuscular Rehabilitation Protocol Improve Disability after a Hemiparetic Stroke? A Pilot Study.

Background: The impairment of limb function and disability are among the most im portant consequences of stroke. To date, however, little research has been done on the early reha bilitation trial (ERT) after stroke in these patients. The purpose of this study was to evaluate the impact of ERT neuromuscular protocol on motor function soon after hemiparetic stroke. The sample included twelve hemiparetic patients (54.3 ± 15.4 years old) with ischemic stroke (n = 7 control, n = 5 intervention patients). ERTwas started as early as possible after stroke and included passive range of motion exercises, resistance training, assisted standing up, and active exercises of the healthy side of the body, in addition to encouraging voluntary contraction of affected limbs as much as possible. The rehabilitation was progressive and took 3 months, 6 days per week, 2–3 h per session. Fu gle-Meyer Assessment (FMA), Box and Blocks test (BBT) and Timed up and go (TUG) assessments were conducted. There was a significantly greater improvement in the intervention group com pared to control: FMA lower limbs (p = 0.001), total motor function (p = 0.002), but no significant difference in FMA upper limb between groups (p = 0.51). The analysis of data related to BBT showed no significant differences between the experimental and control groups (p = 0.3). However, TUG test showed significant differences between the experimental and control groups (p = 0.004). The most important finding of this study was to spend enough time in training sessions and provide adequate rest time for each person. Our results showed that ERT was associated with improved motor function but not with the upper limbs. This provides a basis for a definitive trial.

Factors associated with paid employment 12 months after stroke in A Very Early Rehabilitation Trial (AVERT).

Returning to work is an important outcome for stroke survivors. This sub-study of a randomised controlled trial aimed to provide characteristics of working-age stroke participants and identify factors associated with return to work at 12 months. We used paid employment data collected as part of A Very Early Rehabilitation Trial (AVERT, n=2104), an international randomised controlled trial studying the effects of very early mobilisation after stroke at 56 acute stroke units across Australia, New Zealand, the United Kingdom, Malaysia and Singapore. For the present analysis, data for trial participants < 65 years old were included if they were working at the time of stroke and had complete 12-month return-to-work data. The primary outcome was 12-month return to paid work. Univariable and multivariable logistic regression analyses were conducted to determine the association of multiple factors with return to work. In total, 376 AVERT participants met the inclusion criteria for this sub-study. By 12 months, 221 (59%) participants had returned to work at a median of 38 hr per week. Similar rates were found across geographic regions. On univariable analysis, the odds of returning to paid employment were increased with younger age (OR per year 0.95, 95%CI 0.92-0.97), no previous diabetes (0.4, 0.24-0.67), lower stroke severity (OR per National Institutes of Health Stroke Scale point 0.82, 0.78-0.86), less 3-month depressive traits (Irritability Depression Anxiety [IDA] scale) (OR per IDA point 0.87, 0.80-0.93), less 3-month disability (modified Rankin Scale), and prior full-time work (2.04, 1.23-3.38). On multivariable analysis, return to work remained associated with younger age (OR 0.94, 95%CI 0.91-0.98), lower stroke severity (0.92, 0.86-0.99), prior full-time work (2.33, 1.24-4.40), and less 3-month disability. Return to work at 12 months after stroke was associated with young age, acute stroke severity, 3-month disability and full-time employment before stroke. Greater understanding of this topic could help in developing programs to support successful resumption of work post-stroke.

The economic and health burden of stroke among younger adults in Australia from a societal perspective

BackgroundTo estimate the short term (5 years) and long term (30 years) economic burden of stroke among younger adults (18–64 years), and to calculate the loss of health-related quality of life in these individuals, in Australia.MethodsA Markov microsimulation model was built to simulate incidence of stroke among younger adults in Australia. Younger adults with stroke commenced in the model via health states defined by the modified Rankin Scale at 12 months from the AVERT study (A Very Early Rehabilitation Trial), and transitioned through these health states. Costs in Australian dollars (AUD) were measured from a societal perspective for a 2018 reference year and categorised into medical, non-medical and indirect costs. Probabilistic sensitivity analyses were performed to test the robustness around the cost of illness estimates. The loss of health-related quality of life due to stroke among younger adults was calculated by determining the difference in estimated quality-adjusted life years (QALYs) between the stroke population and the general population. This was determined by multiplying the predicted remaining life years for the modelled stroke cohort and the age-matched general population, by their corresponding age-dependent utilities.ResultsThe economic burden of stroke among younger adults was estimated to be AUD2.0 billion over 5 years, corresponding to a mean of $149,180 per stroke patient. Over 30 years, the economic impact was AUD3.4 billion, equating to a mean of $249,780 per case. Probabilistic sensitivity analyses revealed a mean cost per patient of $153,410 in the short term, and a mean cost per patient of $273,496 in the long term. Compared to the age-matched general population, younger adults with stroke experienced a loss of 4.58 life years and 9.21 QALYs.ConclusionsThe results of our study suggests high economic and health burden of stroke among younger adults and highlights the need for preventive interventions targeting this age group.Trial registrationACTRN12606000185561, retrospectively registered.

Why Are Stroke Rehabilitation Trial Recruitment Rates in Single Digits?

Background: Recruitment of patients in early subacute rehabilitation trials (<30 days post-stroke) presents unique challenges compared to conventional stroke trials recruiting individuals >6 months post-stroke. Preclinical studies suggest treatments be initiated sooner after stroke, thus requiring stroke rehabilitation trials be conducted within days post-stroke. How do specific inclusion and exclusion criteria affect trial recruitment rates for early stroke rehabilitation trials?Objectives: Provide estimates of trial recruitment based on screening and enrollment data from a phase II early stroke rehabilitation trial.Methods: CPASS, a phase II intervention trial screened ischemic stroke patients in acute care (18-months, N = 395) and inpatient rehabilitation (22-months, N = 673). Patients were stratified by upper extremity (UE) impairment into mild (NIHSS motor arm = 0, 1); moderate (NIHSS = 2, 3); severe (NIHSS = 4) and numbers of patients disqualified due to CPASS exclusion criteria determined. We also examined if a motor-specific evaluation (Action Research Arm Test, ARAT) increases the pool of eligible patients disqualified by the NIHSS motor arm item.Results: CPASS recruitment in acute care (5.3%) and inpatient rehabilitation (5%) was comparable to prior trials. In acute care, a short stay (7–17-days), prior stroke (13.5% in moderately; 13.2% in severely impaired) disqualified the majority. In inpatient rehabilitation, the majority (40.8%) were excluded for “too mild” impairment. The next majority were disqualified for reaching inpatient rehabilitation “too late” to participate in an early stroke trial (15% in moderately; 24% in severely impaired). Mean ARAT in the “too mild” showed significant impairment and potential to benefit from participation in select UE rehabilitation trials.Conclusions: Screening of ischemic stroke patients while they are still in acute care is crucial to successful recruitment for early stroke rehabilitation trials. A significant proportion of eligible patients are lost to “short length of stay” in acute care, and arrive to inpatient rehabilitation “too late” for an early rehabilitation trial. Additional screening of mildly impaired patients using a motor function specific scale will benefit the trial recruitment and generalizability.Trial Registration Number: http://www.clinicaltrials.gov Identifier: NCT02235974.

Factors associated with time to independent walking recovery post-stroke

BackgroundPast studies have inconsistently identified factors associated with independent walking post-stroke. We investigated the relationship between pre-stroke factors and factors collected acutely after stroke and number of days to walking...

Occlusive Disease and Upright Activity in Acute Ischemic Stroke

The impact of out-of-bed upright activity on outcomes in ischemic stroke patients with severe extra- and intracranial stenosis or occlusion is unknown. Using ultrasound findings from a cohort recruited to A Very Early Rehabilitation Trial (AVERT) which compared higher dose very early mobilisation (VEM) to usual care (UC), we aimed to explore the association between occlusive disease and 3-month outcomes and occlusive disease-by-mobilisation treatment interactions. Participants with ischemic stroke, with carotid and transcranial Doppler ultrasounds performed ≤1 week after admission, were included in this single centre substudy in Melbourne, Australia. Reports were retrospectively reviewed to determine the degree of stenosis or presence of occlusion in the relevant arterial territory. Stenosis ≥70% extracranial or ≥50% intracranial were classified as severe or occlusion. Overall, 19% (n = 36/191) had occlusive disease in the affected circulation. About 40% (n = 14/36) with occlusive disease and 51% (n = 79/155) without had a 3-month favourable outcome (mRS 0–2) (adjusted OR0.53, CI0.17–1.67). Fourteen percent (n = 5) with occlusive disease and 4% (n = 6) without died by 3 months (adjusted OR2.52, CI0.6–10.7). Fifty percent (n = 11/22) of UC (adjusted OR0.86, CI0.23–3.2) and 21% (n = 3/14) of VEM participants (adjusted OR0.16, CI0.01–2.7) with occlusive disease had a favourable outcome. Almost 30% (n = 4) VEM participants with occlusive disease died (adjusted OR3.99, CI0.69–22.9) compared to 5% (n = 1) UC participants with occlusive disease (adjusted OR0.45, CI0.02–8.6), however numbers were small. No stenosis-by-treatment interactions were found. High quality prospective studies are needed to help guide decision making about when patients with occlusive disease should commence upright activity in acute stroke.

Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke.

This tertiary analysis from A Very Early Rehabilitation Trial (AVERT) examined fatal and nonfatal serious adverse events (SAEs) at 14 days. AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours poststroke, termed very early mobilization (VEM), to usual care (UC). Primary outcome was assessed at 3 months. Patients with ischemic or hemorrhagic stroke within 24 hours of onset were included. Treatment with thrombolytics was allowed. Patients with severe premorbid disability or comorbidities were excluded. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were nonfatal SAEs classified as neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIH Stroke Scale [NIHSS] score) and age. A total of 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (interquartile range [IQR] 63-80) and NIHSS 7 (IQR 4-12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted odds ratio of 1.76 (95% confidence interval 1.06-2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral hemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in nonfatal SAEs was found. While the overall case fatality at 14 days poststroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose and intensive training compared to usual care. Stroke progression was more common in VEM. Australian New Zealand Clinical Trials Registry, ACTRN12606000185561. This study provides Class I evidence that very early mobilization increases mortality at 14 days poststroke.

Look closer: The multidimensional patterns of post-stroke burden behind the modified Rankin Scale.

The utility-weighted modified Rankin Scale, representing patient perspectives of quality of life, is a newly proposed measure to improve the interpretability of the modified Rankin Scale. Despite obvious advantages, such weighting imperfectly reflects the multidimensional patterns of post-stroke burden. To investigate multidimensional patterns of post-stroke burden formed by individual domains of Assessment of Quality of Life and Barthel Index for each modified Rankin Scale category. In the A Very Early Rehabilitation Trial (n = 2104), modified Rankin Scale scores and modified Rankin Scale-stratified Barthel Index scores of Self-care and Mobility, and Assessment of Quality of Life scores of Independent Living, Senses, Mental Health and Relationships were collected at three months. The multivariate relationship between individual Assessment of Quality of Life and Barthel Index domains, and modified Rankin Scale was investigated using random effects linear regression models with respective interaction terms. Of 2104 patients, simultaneously collected Assessment of Quality of Life, Barthel Index and modified Rankin Scale scores at three months were available in 1870 patients. While individual Assessment of Quality of Life and Barthel Index domain scores decreased significantly as modified Rankin Scale increased (p < 0.0001), the patterns of decrease differed by domains (p < 0.0001). Patients with modified Rankin Scale 0-1 had the largest post-stroke burden in the Mental Health and Relationship domains, while patients with modified Rankin Scale >3 showed the greatest burden in Independent Living, Mobility and Self-care domains. Across the modified Rankin Scale, individual domains are varyingly impacted demonstrating unique patterns of post-stroke burden, which facilitates appropriate assessment, articulation and interpretation of the modified Rankin Scale and utility-weighted modified Rankin Scale.

An exploration of aphasia therapy dosage in the first six months of stroke recovery

ABSTRACT Aphasia research uses the length of time within rehabilitation sessions as the main measure of dosage. Few papers detail therapeutic ingredients or outline the number of times these were delivered over the treatment period. The present observational study identified therapeutic ingredients in the Very Early Rehabiltiation in SpEech (VERSE) trial and explored the dosage provided using a model of cumulative intervention intensity (CII). Therapists video recorded one therapy session per week and 53 (12%) randomly selected therapy videos were analysed. The videos were coded for number of error productions, self-corrections and type and frequency of therapist cueing. The Western Aphasia Battery Revised-Aphasia Quotient (WABR-AQ) was used for measuring patient outcome with total verbal utterances (p < 0.001) and cues used with success (p < 0.001) being independent positive predictors of WABR-AQ score at six months post stroke and hypothesized as key therapeutic ingredients. The CII was calculated by counting identified therapeutic ingredients and multiplying this by the number of sessions completed. Collectively, the key ingredients occurred on average 504 times per session and over 10,000 times per participant during the treatment period. This paper reports a novel approach for identifying key treatment ingredients and detailing the dosage delivered within an early aphasia rehabilitation trial.

Exploring post acute rehabilitation service use and outcomes for working age stroke survivors (≤65 years) in Australia, UK and South East Asia: data from the international AVERT trial

ObjectivesInformation about younger people of working age (≤65 years), their post stroke outcomes and rehabilitation pathways can highlight areas for further research and service change. This paper describes: (1) baseline...

The Association Between Frailty and Short-Term Outcomes in an Intensive Care Unit Rehabilitation Trial: An Exploratory Analysis

BackgroundPhysical therapy initiated early in an ICU stay may reduce functional deficits in critically ill patients; however, the association of frailty with outcomes in those receiving early in-ICU rehabilitation is unknown.ObjectiveTo estimate the association between frailty and 3 outcomes in patients enrolled in an ICU randomized clinical trial (RCT).DesignExploratory secondary analyses of the CYCLE pilot RCT (NCT02377830).Setting7 Canadian ICUs.ParticipantsPreviously ambulatory critically ill adults.InterventionParticipants were randomized to early in-bed cycling plus routine physiotherapy versus early routine physiotherapy alone.MeasurementsUsing regression analyses, we modelled the association between pre-hospital Clinical Frailty Scale (CFS) scores, Physical Function in ICU Test-scored (PFIT-s), muscle strength, and mortality at hospital discharge, adjusting for illness severity (APACHE II) and the randomized intervention. We explored the influence of imputing mean PFIT-s and strength scores for decedents, and with listwise deletion of decedents in a sensitivity analysis.ResultsOf 66 patients, 2 had missing data, 2 had incomplete data, and 21 died by hospital discharge. At hospital discharge for 66 patients, frailty was not associated with PFIT-s (mean difference (MD) [95% CI]=0.20, [−2.08, 2.74]) or muscle strength (1.96, [−12.6, 16.6]). A sensitivity analysis yielded consistent results. Frailty was also not associated with hospital mortality (odds ratio 0.91, [0.28 to 2.93]).ConclusionWe found no association between pre-hospital frailty, physical function, strength, or mortality at hospital discharge in critically ill patients enrolled in an early rehabilitation trial. Larger sample sizes are needed to further explore the association of frailty with these outcomes at hospital discharge.

NQPC-07 IMMEDIATE POSTOPERATIVE REHABILITATION FOR PATIENTS WITH NEWLY-DIAGNOSED GLIOMA

BACKGROUNDSImportance of early intensive rehabilitation is recently emphasized not only for Stroke Unit but for Intensive Care Unit. We have started such early comprehensive rehabilitation for patients after brain tumor surgery. Rehabilitation therapists were specially assigned to our brain surgery unit as members of the ward staffers. The purpose of this study is to show how this rehabilitation trial works for post-surgery patients with glioma.METHODSThirty-two patients with glioma (20 males and 12 females) who were admitted to our institution in the year of 2018 were included. Mean age was 61.8±13.3 years; glioblastoma was the major tumor type (24 patients). We retrospectively analyzed rehabilitation outcome focusing on improvement of the Functional Independence Measure (FIM) scores during hospitalization.RESULTSMean duration from surgery to the first rehabilitation intervention was 2.4±1.2 days, and mean hospital stay was 74.4±31.4days. Twenty patients were discharged to home (62 %) and 12 were transferred to other hospitals for convalescence. Motor, cognitive and total FIM scores were 41.0±22.2, 18.0±7.5, and 59.1±27.3 before surgery, whereas they were 61.4±28.6, 21.8±9.4, and 83.2±36.9, respectively, at discharge. Motor FIM items revealed more remarkable improvement than those of cognitive ones. Since starting the early intensive rehabilitation trial, patients with brain tumor have been systematically rehabilitated with an organized manner before and after surgery.CONCLUSIONEarly intensive rehabilitation for patients with brain tumor is recommended to be done by on-ward therapists who are assigned to work specially as members of the ward. Both motor and cognitive improvement is expected during hospitalization even in patients with malignant brain tumor.

Mobilization for Persons With Acute Stroke: A Survey of Current Physical Therapy Clinical Practice

Purpose: To examine reported practice patterns of physical therapists (PTs) related to mobilization of persons with acute stroke. The researchers hypothesized that (1) facilities certified as primary stroke centers by The Joint Commission (TJC) will mobilize persons with acute stroke 24 hours or less after symptom onset; (2) persons with fewer impairments following acute stroke and those with ischemic stroke, who did not receive tissue plasminogen activator (tPA), are mobilized sooner; (3) PTs are the first to mobilize among interdisciplinary team members; and (4) PTs with more experience will mobilize sooner than novice PTs. Methods Survey Development: All members of the research team independently searched and reviewed the current literature describing the timing of initial mobilization after stroke. A pilot survey was developed from themes in the literature emphasizing areas hypothesized. Once the feedback from the pilot survey was reviewed, the survey was finalized and converted to an online survey using SurveyMonkey. Survey Implementation and Analysis: The target audience for the survey was PTs who treat persons with acute stroke. “Acute stroke,” for this survey, was defined as a stroke less than 1 week from onset of stroke symptoms. Potential respondents were contacted via e-mail through the APTA acute care and neurologic listservs. The survey contained 26 questions related to participant demographics, the timing and frequency of mobilization for persons with acute stroke based on defined impairment levels, perceptions about influences on mobilization, and knowledge of current related evidence. Descriptive result statistics were generated by SurveyMonkey. One-way analysis of variance was used to compare responses by practice setting, degree, APTA membership, and specialist certification. Spearman's rank correlation was used to correlate results based on participant characteristics. Results: A total of 161 PTs participated with a mean of 15 years' clinical practice. Most (67%) of the respondents report mobilizing persons with minimal impairment and uncomplicated ischemic stroke, not treated with tPA, in 24 hours or less. PTs were identified as the first to mobilize persons after stroke with severe (95%) and moderate impairments (91%). Recipients of tPA, persons with severe impairment, and those who received neurosurgical intervention were initially mobilized between 25 and 48 hours majority of the time. PTs working for a TJC stroke-certified institution did not mobilize sooner. The number of years of PT experience had a weak negative correlation to the timing of mobilization. Most respondents (58%) reported that mobilization more than 2 times per day is optimal. The barriers to more frequent mobilization included increased caseload, lack of resources, and lack of interdisciplinary patient care coordination. Conclusions: The frequency of mobilization reported in this survey is less than proposed by the results of the most recent “A Very Early Rehabilitation Trial” (AVERT) after stroke, phase 3 trial. This study found a positive correlation between increased session frequency and recovery of walking at 3 months, survival, and a modified Rankin Scale (mRS) score of 2 or less. Respondents believe additional mobilization would be beneficial, but report barriers to implementation that include increased PT caseloads and lack of resources. Additional research is required to determine the influence of mobilization timing and frequency on patient outcomes such as the degree of disability after stroke.

Early mobilization and quality of life after stroke: Findings from AVERT.

To determine whether early and more frequent mobilization after stroke affects health-related quality of life. A Very Early Rehabilitation Trial (AVERT) was an international, multicenter (56 sites), phase 3 randomized controlled trial, spanning 2006-2015. People were included if they were aged ≥18 years, presented within 24 hours of a first or recurrent stroke (ischemic or hemorrhagic), and satisfied preordained physiologic criteria. Participants were randomized to usual care alone or very early and more frequent mobilization in addition to usual care. Quality of life at 12 months was a prespecified secondary outcome, evaluated using the Assessment of Quality of Life 4D (AQoL-4D). This utility-weighted scale has scores ranging from -0.04 (worse than death) to 1 (perfect health). Participants who died were assigned an AQoL-4D score of 0. No significant difference in quality of life at 12 months between intervention (median 0.47, interquartile range [IQR] 0.07-0.81) and usual care (median 0.49, IQR 0.08-0.81) groups was identified (p = 0.86), nor were there any group differences across the 4 AQoL-4D domains. The same lack of group difference in quality of life was observed at 3 months. When cohort data were analyzed (both groups together), quality of life was strongly associated with acute length of stay, independence in activities of daily living, cognitive function, depressive symptoms, and anxiety symptoms (all p < 0.001). Quality of life in AVERT participants was substantially lower than population norms, and the gap increased with age. Earlier and more frequent mobilization after stroke did not influence quality of life. anzctr.org.au; ACTRN12606000185561 CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for people with stroke, earlier and more frequent mobilization did not influence quality of life over the subsequent year.

Utility-weighted modified Rankin Scale: Still too crude to be a truly patient-centric primary outcome measure?

The utility-weighted modified Rankin Scale (UW-mRS) is an outcome measure recently proposed to improve statistical efficiency and interpretability of the mRS. Statistical properties of the UW-mRS have been well investigated, but construct validity has yet to be established. To investigate the construct validity of the UW-mRS as a primary outcome measure by assessing variability in utility values within and between mRS categories, over time post-stroke, and by different derivation methods. UW-mRS was derived using assessment of quality of life (AQoL-4D) and mRS scores at 3 and 12 months (n = 2030) from a large randomized controlled trial, A Very Early Rehabilitation Trial (AVERT). Receiver operator characteristic (ROC) analysis of AQoL-4D was conducted to differentiate between sequential mRS categories. Intraclass correlation was used to explore variability in utility values over time post-stroke, UW-mRS values, and derivation methods from multiple studies. UW-mRS values for mRS categories 0-6 at three months were 0.80, 0.78, 0.63, 0.37, 0.11, 0.03, and 0. Based on AQoL-4D utility values, areas under the ROC curve varied from 0.54 to 0.87. Time post-stroke explained 42%-56% of variability in AQoL-4D utility values in patients with no change in mRS between 3 and 12 months. The choice of the derivation method contributed to 25% of the variability in UW-mRS values. The high variability in utility values between and within mRS categories, over time post-stroke, and using different derivation methods is not adequately reflected in the UW-mRS. These threats to construct validity warrant caution when using UW-mRS as a primary outcome measure. Australian New Zealand Clinical Trials Registry (ACTRN12606000185561).

A early rehabilitation trial for ischemic stroke

A early rehabilitation trial for ischemic stroke

The Best Time to Start Stroke Rehabilitation: A Review of the Evidence in ResourceAdequate and Resource Constrained Settings

Background: Stroke is a global health problem and one of the major causes of death, disability and impairment among adults worldwide. Post-stroke outcomes vary widely, between and within world regions depending on a range of factors including demographic profile, stroke type, severity and immediate and long-term post stroke care. It has been reported that early initiation of rehabilitation following stroke promotes better long-term outcomes than delayed rehabilitation, although this has been disputed by some researchers in the AVERT (A very early rehabilitation trial) study. Purpose of Review: To evaluate the best time to start stroke rehabilitation with good outcomes Results of the Review: There is limited evidence to show that later rehabilitation is better than early rehabilitation. It also remains unclear whether early mobilization is more effective than mobilization at a later stage, due to insufficient statistical power of the studies that have examined this practice because clinicians around the world are practicing this model to this day. Furthermore, some trial limitations of the AVERT study in line with the uncertainty of the external validity of the results, make generalizability something to be concerned about. Conclusion: The best time to start stroke rehabilitation is as soon as the patient is clinically stable i.e; as early as possible. The results of the poor outcomes of the AVERT study in providing evidence of the impact of early stroke rehabilitation, should not be interpreted as proof of the ineffectiveness of early physical rehabilitation. Every stroke is different from one person to another because the impact of the damage to the brain is associated with the different functions of several parts of the brain making generalizability quite difficult. Therefore, in the absence of provision of high quality evidence, clinicians like physiotherapists should base their decisions on clinical experience, individual circumstances and patient preferences as appropriate. It is extremely important to develop evidence-based practice protocols that can guide clinical practice on the best time to start stroke rehabilitation and also enhancing plasticity and reducing the negative impact of stroke through pharmacotherapy, especially for

The AVERT MoCA Data: Scoring Reliability in a Large Multicenter Trial.

The Montreal Cognitive Assessment (MoCA) is a widely used cognitive screening tool in stroke. As scoring the visuospatial/executive MoCA items involves subjective judgement, reliability is important. Analyzing data on these items from A Very Early Rehabilitation Trial (AVERT), we compared the original scoring of assessors (n = 102) to blind scoring by a single, independent rater. In a sample of scoresheets from 1,119 participants, we found variable interrater reliability. The match between original assessors and the independent rater was the following: trail-making 97% (κ = 0.94), cube copy 90% (κ = 0.80), clock contour 92% (κ = 0.49), clock numbers 89% (κ = 0.67), and clock hands 72% (κ = 0.46). For all items except clock contour, the independent rater was "stricter" than the original assessors. Discrepancies were typically errors in original scoring, rather than borderline differences in subjective judgement. In trials that include the MoCA, researchers should emphasize scoring rules to assessors and implement independent data checking, especially for clock hands, to maximize accuracy.