Physiotherapy - Research Publications

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    Clinical and systems of care factors contributing to individual patient decision-making for early mobilization post-stroke
    Rethnam, V ; Hayward, KS ; Johns, H ; Carvalho, LB ; Churilov, L ; Bernhardt, J (Frontiers Media SA, )
    Introduction Many stroke guidelines recommend against starting intensive out-of-bed activity (mobilization) within 24 h post-stroke. Few guidelines address care after the first 24–48 h, and little information is provided about how early mobilization decisions should be tailored to patients. We aimed to identify clinical and systems of care factors contributing to individual patient decision-making for early mobilization post-stroke. Methods Expert stroke clinicians were recruited to participate in an interactive one-on-one session that included an introductory semi-structured interview followed by an assisted data exploration session using an early mobilization data visualization tool. Results Thirty expert stroke clinicians with a median (interquartile range) 14 (10–25) years of experience were included. Stroke type and severity, and medical stability were identified as important clinical decision-making factors by the majority of expert stroke clinicians. Inadequate staffing and equipment were frequently indicated as barriers to early mobilization. The perceived characteristics of early mobilization responders were mild or moderate stroke severity, ischemic stroke, partial anterior circulation stroke, younger age, and one or fewer comorbidities. Perceived characteristics of early mobilization non-responders included severe stroke severity, hemorrhagic stroke, total anterior circulation stroke, older age, those with persistent vessel occlusion or high-grade stenosis, hemodynamic instability, multimorbidity and an altered state of consciousness. Some characteristics led to uncertainty amongst interviewees e.g., early mobilization decision-making were moderate stroke severity, older patients, and those with lacunar circulation infarcts. Discussion We gained unique, in-depth insights into patient and systems of care factors that contribute to individual patient decision-making related to early mobilization post-stroke. The identified areas would benefit from further empirical research to develop structured decision support for clinicians.
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    Examining Dose Frameworks to Improve Aphasia Rehabilitation Research
    Harvey, S ; Rose, ML ; Brogan, E ; Pierce, JE ; Godecke, E ; Brownsett, SLE ; Churilov, L ; Copland, D ; Dickey, MW ; Dignam, J ; Lannin, NA ; Nickels, L ; Bernhardt, J ; Hayward, KS (W B SAUNDERS CO-ELSEVIER INC, 2023-05)
    The effect of treatment dose on recovery of post-stroke aphasia is not well understood. Inconsistent conceptualization, measurement, and reporting of the multiple dimensions of dose hinders efforts to evaluate dose-response relations in aphasia rehabilitation research. We review the state of dose conceptualization in aphasia rehabilitation and compare the applicability of 3 existing dose frameworks to aphasia rehabilitation research-the Frequency, Intensity, Time, and Type (FITT) principle, the Cumulative Intervention Intensity (CII) framework, and the Multidimensional Dose Articulation Framework (MDAF). The MDAF specifies dose in greater detail than the CII framework and the FITT principle. On this basis, we selected the MDAF to be applied to 3 diverse examples of aphasia rehabilitation research. We next critically examined applicability of the MDAF to aphasia rehabilitation research and identified the next steps needed to systematically conceptualize, measure, and report the multiple dimensions of dose, which together can progress understanding of the effect of treatment dose on outcomes for people with aphasia after stroke. Further consideration is required to enable application of this framework to aphasia interventions that focus on participation, personal, and environmental interventions and to understand how the construct of episode difficulty applies across therapeutic activities used in aphasia interventions.
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    Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke
    Bernhardt, J ; Borschmann, K ; Collier, JM ; Thrift, AG ; Langhorne, P ; Middleton, S ; Lindley, RI ; Dewey, HM ; Bath, P ; Said, CM ; Churilov, L ; Ellery, F ; Bladin, C ; Reid, CM ; Frayne, JH ; Srikanth, V ; Read, SJ ; Donnan, GA (LIPPINCOTT WILLIAMS & WILKINS, 2021-02-23)
    OBJECTIVE: This tertiary analysis from A Very Early Rehabilitation Trial (AVERT) examined fatal and nonfatal serious adverse events (SAEs) at 14 days. METHOD: 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. RESULTS: 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. CONCLUSION: 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. REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12606000185561. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that very early mobilization increases mortality at 14 days poststroke.
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    Early Mobilization After Stroke: Do Clinical Practice Guidelines Support Clinicians' Decision-Making?
    Rethnam, V ; Hayward, KS ; Bernhardt, J ; Churilov, L (FRONTIERS MEDIA SA, 2021-02-05)
    Importance: Early mobilization, out-of-bed activity, is a component of acute stroke unit care; however, stroke patient heterogeneity requires complex decision-making. Clinically credible and applicable CPGs are needed to support and optimize the delivery of care. In this study, we are specifically exploring the role of clinical practice guidelines to support individual patient-level decision-making by stroke clinicians about early mobilization post-stroke. Methods: Our study uses a novel, two-pronged approach. (1) A review of CPGs containing recommendations for early mobilization practices published after 2015 was appraised using purposely selected items from the Appraisal of Guidelines Research and Evaluation-Recommendations Excellence (AGREE-REX) tool relevant to decision-making for clinicians. (2) A cross-sectional study involving semi-structured interviews with Australian expert stroke clinicians representing content experts and CPG target users. Every CPG was independently assessed against the AGREE-REX standard by two reviewers. Expert stroke clinicians, invited via email, were recruited between June 2019 to March 2020.The main outcomes from the review was the proportion of criteria addressed for each AGREE-REX item by individual and all CPG(s). The main cross-sectional outcomes were the distributions of stroke clinicians' responses about the utility of CPGs, specific areas of uncertainty in early mobilization decision-making, and suggested parameters for inclusion in future early mobilization CPGs. Results: In 18 identified CPGs, many did not adequately address the "Evidence" and "Applicability to Patients" AGREE-REX items. Out of 30 expert stroke clinicians (11 physicians [37%], 11 physiotherapists [37%], 8 nurses [26%]; median [IQR] years of experience, 14 [10-25]), 47% found current CPGs "too broad or vague," while 40% rely on individual clinical judgement and interpretation of the evidence to select an evidence-based choice of action. The areas of uncertainty in decision-making revealed four key suggestions: (1) more granular descriptions of patient and stroke characteristics for appropriate tailoring of decisions, (2) clear statements about when clinical flexibility is appropriate, (3) detailed description of the intervention dose, and (4) physical assessment criteria including safety parameters. Conclusions: The lack of specificity, clinical applicability, and adaptability of current CPGs to effectively respond to the heterogeneous clinical stroke context has provided a clear direction for improvement.
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    Factors associated with improved walking in older people during hospital rehabilitation: secondary analysis of a randomized controlled trial
    Said, CM ; McGinley, JL ; Szoeke, C ; Workman, B ; Hill, KD ; Wittwer, JE ; Woodward, M ; Liew, D ; Churilov, L ; Bernhardt, J ; Morris, ME (BMC, 2021-01-31)
    BACKGROUND: Older people are often admitted for rehabilitation to improve walking, yet not everyone improves. The aim of this study was to determine key factors associated with a positive response to hospital-based rehabilitation in older people. METHODS: This was a secondary data analysis from a multisite randomized controlled trial. Older people (n= 198, median age 80.9 years, IQR 76.6- 87.2) who were admitted to geriatric rehabilitation wards with a goal to improve walking were recruited. Participants were randomized to receive additional daily physical therapy focused on mobility (n = 99), or additional social activities (n = 99). Self-selected gait speed was measured on admission and discharge. Four participants withdrew. People who changed gait speed ≥0.1 m/s were classified as 'responders' (n = 130); those that changed <0.1m/s were classified as 'non-responders' (n = 64). Multivariable logistic regression explored the association of six pre-selected participant factors (age, baseline ambulation status, frailty, co-morbidities, cognition, depression) and two therapy factors (daily supervised upright activity time, rehabilitation days) and response. RESULTS: Responding to rehabilitation was associated with the number of days in rehabilitation (OR 1.04; 95% CI 1.00 to 1.08; p = .039) and higher Mini Mental State Examination scores (OR 1.07, 95% CI 1.00 - 1.14; p = .048). No other factors were found to have association with responding to rehabilitation. CONCLUSION: In older people with complex health problems or multi-morbidities, better cognition and a longer stay in rehabilitation were associated with a positive improvement in walking speed. Further research to explore who best responds to hospital-based rehabilitation and what interventions improve rehabilitation outcomes is warranted. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000884707; ClinicalTrials.gov Identifier NCT01910740 .
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    A systematic review protocol of timing, efficacy and cost effectiveness of upper limb therapy for motor recovery post-stroke
    Hayward, KS ; Kramer, SF ; Thijs, V ; Ratcliffe, J ; Ward, NS ; Churilov, L ; Jolliffe, L ; Corbett, D ; Cloud, G ; Kaffenberger, T ; Brodtmann, A ; Bernhardt, J ; Lannin, NA (BMC, 2019-07-25)
    BACKGROUND: Improving upper limb (UL) motor recovery after stroke represents a major clinical and scientific goal. We aim to complete three systematic reviews to estimate the (1) association between time to start of UL therapy and motor recovery, (2) relative efficacy of different UL therapy approaches post-stroke and (3) cost-effectiveness of UL therapy interventions. METHODS: We have designed a systematic review protocol to address three systematic review questions that were each registered with PROSPERO. The search will be conducted in MEDLINE, EMBASE, and Cochrane Controlled Register of Trials. We will include randomised controlled trials, non-randomised clinical trials, before-after studies and observational studies of adult stroke survivors with an average stroke onset < 6 months, undergoing hospital-based therapy to improve UL function. Eligible interventions will aim to promote UL functional recovery. Two reviewers will independently screen, select and extract data. Study risk of bias will be appraised using appropriate tools. Clinical measures of motor recovery will be investigated (primary measure Fugl Meyer UL assessment), as well as measures of health-related quality of life (primary measure EQ-5D) and all cost-effectiveness analyses completed. Secondary outcomes include therapy dose (minutes, weeks, repetitions as available) and safety (i.e. adverse events, serious adverse events). A narrative synthesis will describe quality and content of the evidence. If feasible, we will conduct random effects meta-analyses where appropriate. DISCUSSION: We anticipate the findings of this review will increase our understanding of UL therapy and inform the generation of novel, data-driven hypotheses for future UL therapy research post-stroke. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018019367, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018111629, http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018111628.
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    A stroke recovery trial development framework: Consensus-based core recommendations from the Second Stroke Recovery and Rehabilitation Roundtable
    Bernhardt, J ; Hayward, KS ; Dancause, N ; Lannin, NA ; Ward, NS ; Nudo, RJ ; Farrin, A ; Churilov, L ; Boyd, LA ; Jones, TA ; Carmichael, ST ; Corbett, D ; Cramer, SC (SAGE PUBLICATIONS LTD, 2019-10)
    A major goal of the Stroke Recovery and Rehabilitation Roundtable (SRRR) is to accelerate development of effective treatments to enhance stroke recovery beyond that expected to occur spontaneously or with current approaches. In this paper, we describe key issues for the next generation of stroke recovery treatment trials and present the Stroke Recovery and Rehabilitation Roundtable Trials Development Framework (SRRR-TDF). An exemplar (an upper limb recovery trial) is presented to demonstrate the utility of this framework to guide the GO, NO-GO decision-making process in trial development.
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    Rationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review
    Borschmann, K ; Hayward, KS ; Raffelt, A ; Churilov, L ; Kramer, S ; Bernhardt, J (HINDAWI LTD, 2018)
    BACKGROUND: The ineffectiveness of most complex stroke recovery trials may be explained by inadequate intervention design. The primary aim of this review was to explore the rationales given for interventions and dose in stroke rehabilitation randomised controlled trials (RCTs). METHODS: We searched the Cochrane Stroke Group library for RCTs that met the following criteria: (1) training based intervention; (2) >50% participants who were stroke survivors; (3) full peer-reviewed text; (4) English language. We extracted data on 16 quality items covering intervention dose (n= 3), trial design (n= 10), and risk of bias (n= 3) and 18 items related to trial method. Logistic regression analyses were performed to determine whether (1) reporting of trial quality items changed over time; (2) reporting of quality items was associated with the likelihood of a positive trial, adjusted for sample size and number of outcomes. RESULTS: 27 Cochrane reviews were included, containing 9,044 participants from 194 trials. Publication dates were 1979 to 2013, sample size was median 32 (IQR 20,58), and primary outcome was reported in 49 trials (25%). The median total quality score was 4 (IQR 3,6) and improved significantly each year (OR 1.12, 95% CI 1.07, 1.16, p<0.001). Total quality score was not associated with likelihood of a positive trial, but trials containing a biological rationale for the intervention were more likely to find a difference in patient outcome (OR 2.18, 95% CI 1.14, 4.19, p=0.02). CONCLUSION: To develop breakthrough treatments we need to build the rationale for research interventions and testing of intervention dosage. This will be achieved through a collective research agenda to understand the mechanistic principles that drive recovery and identification of clearer targets for clinical trials.
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    Enhancing physical activity in older adults receiving hospital based rehabilitation: a phase II feasibility study
    Said, CM ; Morris, ME ; Woodward, M ; Churilov, L ; Bernhardt, J (BMC, 2012-06-08)
    BACKGROUND: Older adults receiving inpatient rehabilitation have low activity levels and poor mobility outcomes. Increased physical activity may improve mobility. The objective of this Phase II study was to evaluate the feasibility of a randomized controlled trial (RCT) of enhanced physical activity in older adults receiving rehabilitation. METHODS: Patients admitted to aged care rehabilitation with reduced mobility were randomized to receive usual care or usual care plus additional physical activity, which was delivered by a physiotherapist or physiotherapy assistant. The feasibility and safety of the proposed RCT protocol was evaluated. The primary clinical outcome was mobility, which was assessed on hospital admission and discharge by an assessor blinded to group assignment. To determine the most appropriate measure of mobility, three measures were trialled; the Timed Up and Go, the Elderly Mobility Scale and the de Morton Mobility Index. RESULTS: The protocol was feasible. Thirty-four percent of people admitted to the ward were recruited, with 47 participants randomised to a control (n = 25) or intervention group (n = 22). The rates of adverse events (death, falls and readmission to an acute service) did not differ between the groups. Usual care therapists remained blind to group allocation, with no change in usual practice. Physical activity targets were met on weekdays but not weekends and the intervention was acceptable to participants. The de Morton Mobility Index was the most appropriate measure of mobility. CONCLUSIONS: The proposed RCT of enhanced physical activity in older adults receiving rehabilitation was feasible. A larger multi-centre RCT to establish whether this intervention is cost effective and improves mobility is warranted. TRIAL REGISTRATION: The trial was registered with the ANZTCR (ACTRN12608000427370).
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    Measuring Activity Levels at an Acute Stroke Ward: Comparing Observations to a Device
    Kramer, SF ; Cumming, T ; Churilov, L ; Bernhardt, J (HINDAWI LTD, 2013)
    BACKGROUND: If a simple system of instrumented monitoring was possible early after stroke, therapists may be able to more readily gather information about activity and monitor progress over time. Our aim was to establish whether a device containing a dual-axis accelerometer provides similar information to behavioural mapping on physical activity patterns early after stroke. METHODS: Twenty participants with recent stroke ≤ 2 weeks and aged >18 were recruited and monitored at an acute stroke ward. The monitoring device (attached to the unaffected leg) and behavioural mapping (observation) were simultaneously applied from 8 a.m. to 5 p.m. Both methods recorded the time participants spent lying, sitting, and upright. RESULTS: The median percentage and interquartile range (IQR) of time spent lying, sitting, and upright recorded by the device were 36% (15-68), 51% (28-72), and 2% (1-5), respectively. Agreement between the methods was substantial: Intraclass Correlation Coefficient (95% CI): lying 0.74 (0.46-0.89), sitting 0.68 (0.36-0.86), and upright 0.72 (0.43-0.88). CONCLUSION: Patients are inactive in an acute stroke setting. In acute stroke, estimates of time spent lying, sitting, and upright measured by a device are valid.