Medicine (Austin & Northern Health) - Research Publications
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ItemChanges in Activity Levels in the First Month after Stroke(SOC PHYSICAL THERAPY SCIENCE, 2013-05)[Purpose] To quantify the activity levels of individuals in an acute stroke ward, and to determine if their activity levels change within the first month after stroke. [Methods] In this pilot study, participant activity was monitored prospectively over a single day from 8 a.m. to 5 p.m. on two separate occasions. Individuals with confirmed stroke > 18 years of age and less than 15 days post-stroke at the time of recruitment were eligible for inclusion in this study. Activity was recorded using an electronic device. The first day was scheduled within 15 days and the second at four weeks post-stroke. We looked at the following activity categories: number of transitions, and the times spent lying, sitting and in dynamic activity. [Results] Sixteen individuals were included in this study with a median age of 79.5 years (interquartile range 62.5 to 85). Fifty-six % of the participants had mild, 31% had moderate and 13% had severe stroke, according to the NIHSS score. There were no significant changes in number of transitions, or times spent in dynamic activity and lying and sitting. [Conclusion] Activity levels were low at an acute stroke ward and did not significantly change within the first month.
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ItemUpright activity and higher motor function may preserve bone mineral density within 6 months of stroke: a longitudinal study(SPRINGER LONDON LTD, 2018-01-08)PURPOSE: Bone fragility contributes to increased fracture risk, but little is known about the emergence of post-stroke bone loss. We investigated skeletal changes and relationships with physical activity, stroke severity, motor control and lean mass within 6 months of stroke. METHODS: This is a prospective observational study. Participants were non-diabetic but unable to walk within 2 weeks of first stroke. Distal tibial volumetric bone mineral density (vBMD, primary outcome), bone geometry and microstructure (high-resolution peripheral quantitative computed tomography) were assessed at baseline and 6 months, as were secondary outcomes total body bone mineral content and lean mass (dual energy X-ray absorptiometry), bone metabolism (serum osteocalcin, N-terminal propeptide of type 1 procollagen (P1NP), C-terminal telopeptide of type 1 collagen (CTX)), physical activity (PAL2 accelerometer) and motor control (Chedoke McMaster) which were also measured at 1 and 3 months. RESULTS: Thirty-seven participants (69.7 years (SD 11.6), 37.8% females, NIHSS 12.6 (SD 4.7)) were included. The magnitude of difference in vBMD between paretic and non-paretic legs increased within 6 months, with a greater reduction observed in paretic legs (mean difference = 1.5% (95% CI 0.5, 2.6), p = 0.007). At 6 months, better motor control was associated with less bone loss since stroke (r = 0.46, p = 0.02). A trend towards less bone loss was observed in people who regained independent walking compared to those who did not (p = 0.053). Higher baseline daily count of standing up was associated with less change in bone turnover over 6 months: osteocalcin (r = -0.51, p = 0.01), P1NP (r = -0.47, p = 0.01), CTX (r = -0.53, p = 0.01). CONCLUSION: Better motor control and walking recovery were associated with reduced bone loss. Interventions targeting these impairments from early post-stroke are warranted. CLINICAL TRIAL REGISTRATION: URL: http://www.anzctr.org.au . Unique identifier: ACTRN12612000123842.
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ItemEconomic evaluation of a phase III international randomised controlled trial of very early mobilisation after stroke (AVERT)(BMJ PUBLISHING GROUP, 2019-05)OBJECTIVES: While very early mobilisation (VEM) intervention for stroke patients was shown not to be effective at 3 months, 12 month clinical and economical outcomes remain unknown. The aim was to assess cost-effectiveness of a VEM intervention within a phase III randomised controlled trial (RCT). DESIGN: An economic evaluation alongside a RCT, and detailed resource use and cost analysis over 12 months post-acute stroke. SETTING: Multi-country RCT involved 58 stroke centres. PARTICIPANTS: 2104 patients with acute stroke who were admitted to a stroke unit. INTERVENTION: A very early rehabilitation intervention within 24 hours of stroke onset METHODS: Cost-utility analyses were undertaken according to pre-specified protocol measuring VEM against usual care (UC) based on 12 month outcomes. The analysis was conducted using both health sector and societal perspectives. Unit costs were sourced from participating countries. Details on resource use (both health and non-health) were sourced from cost case report form. Dichotomised modified Rankin Scale (mRS) scores (0 to 2 vs 3 to 6) and quality adjusted-life years (QALYs) were used to compare the treatment effect of VEM and UC. The base case analysis was performed on an intention-to-treat basis and 95% CI for cost and QALYs were estimated by bootstrapping. Sensitivity analysis were conducted to examine the robustness of base case results. RESULTS: VEM and UC groups were comparable in the quantity of resource use and cost of each component. There were no differences in the probability of achieving a favourable mRS outcome (0.030, 95% CI -0.022 to 0.082), QALYs (0.013, 95% CI -0.041 to 0.016) and cost (AUD1082, 95% CI -$2520 to $4685 from a health sector perspective or AUD102, 95% CI -$6907 to $7111, from a societal perspective including productivity cost). Sensitivity analysis achieved results with mostly overlapped CIs. CONCLUSIONS: VEM and UC were associated with comparable costs, mRS outcome and QALY gains at 12 months. Compared with to UC, VEM is unlikely to be cost-effective. The long-term data collection during the trial also informed resource use and cost of care post-acute stroke across five participating countries. TRIAL REGISTRATION NUMBER: ACTRN12606000185561; Results.
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ItemA systematic review protocol of timing, efficacy and cost effectiveness of upper limb therapy for motor recovery post-stroke(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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ItemNo Preview AvailableA stroke recovery trial development framework: Consensus-based core recommendations from the Second Stroke Recovery and Rehabilitation Roundtable(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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ItemRationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review(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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ItemA Framework for Designing Inpatient Stroke Rehabilitation Facilities: A New Approach Using Interdisciplinary Value-Focused Thinking(SAGE PUBLICATIONS INC, 2019-10)AIM: To use Value-Focused Thinking to investigate what is important in the design of inpatient stroke rehabilitation facility buildings. BACKGROUND: Many stroke patients require inpatient rehabilitation in a dedicated facility. Rehabilitation facilities are healthcare spaces, but they are also learning spaces where patients practice targeted tasks to acquire new skills and to reacquire skills and abilities that were compromised as a result of their stroke. There is currently no consensus regarding how the design of inpatient rehabilitation facilities could be optimized for patients' learning. METHOD: We used Value-Focused Thinking to develop a framework of what interdisciplinary experts consider important for inpatient stroke rehabilitation facility design. Two workshops were conducted. The following experts were invited to participate: past patients with experience of stroke rehabilitation; stroke rehabilitation clinicians; stroke rehabilitation academics; healthcare environments academics; learning environments academics; architects, designers, and wayfinders with experience designing healthcare or learning environments; and healthcare design policy makers. RESULTS: Thirty experts participated. The experts' final framework included 16 criteria that were considered fundamentally important for inpatient stroke rehabilitation facility design, and 14 criteria that were considered instrumentally important. Inpatient stroke rehabilitation facility design should maximize efficiency, maximize effectiveness (i.e., patients' clinical and functional outcomes), foster emotional well-being, and maximize safety. Opportunities to practice physical, cognitive, and social activity were considered important for patients' outcomes. CONCLUSIONS: Value-Focused Thinking was an effective and equitable means of engaging experts from multiple disciplines. Designers, planners, and developers of inpatient stroke rehabilitation facilities should consider the rehabilitation-specific framework developed in this study alongside evidence from other healthcare settings.
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ItemEnhancing physical activity in older adults receiving hospital based rehabilitation: a phase II feasibility study(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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ItemMobilization after thrombolysis (rtPA) within 24 hours of acute stroke: what factors influence inclusion of patients in A Very Early Rehabilitation Trial (AVERT)?(BMC, 2014-08-27)BACKGROUND: A key treatment for acute ischaemic stroke is thrombolysis (rtPA). However, treatment is not devoid of side effects and patients are carefully selected. AVERT (A Very Early Rehabilitation Trial), a large, ongoing international phase III trial, tests whether starting out of bed activity within 24 hours of stroke onset improves outcome. Patients treated with rtPA can be recruited if the physician allows (447 included to date). This study aimed to identify factors that might influence the inclusion of rtPA treated patients in AVERT. METHODS: Data from all patients thrombolysed at Austin Health, Australia, between September 2007 and December 2011 were retrospectively extracted from medical records. Factors of interest included: demographic and stroke characteristics, 24 hour clinical response to rtPA treatment, cerebral imaging and process factors (day and time of admission). RESULTS: 211 patients received rtPA at Austin Health and 50 (24%) were recruited to AVERT (AVERT). Of the 161 patients not recruited, 105 (65%) were eligible, and could potentially have been included (pot-AVERT). There were no significant differences in demographics, Oxfordshire classification or stroke severity (NIHSS) on admission between groups. Size and localization of stroke on imaging and symptomatic intracerebral heamorrhage rate did not differ. Patients included in AVERT showed less change in NIHSS 24 hours post rtPA (median change = 1, IQR (-1,4)) than those in the pot-AVERT group (median change = 3, IQR (0,6)) by the median difference of 2 points (95%CI:0.3; p = 0.03). A higher proportion of rtPA treated AVERT patients were admitted on weekdays (p = 0.04). CONCLUSION: Excluding a possible clinical instability, no significant clinical differences were identified between thrombolysed patients included in AVERT and those who were not. Over 500 AVERT patients will be treated with rtPA at trial end. These results suggest we may be able to generalize findings to other rtPA treated patients beyond the trial population.
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ItemMeasuring Activity Levels at an Acute Stroke Ward: Comparing Observations to a Device(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.