Physiotherapy - Research Publications

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    Are we armed with the right data? Pooled individual data review of biomarkers in people with severe upper limb impairment after stroke
    Hayward, KS ; Schmidt, J ; Lohse, KR ; Peters, S ; Bernhardt, J ; Lannin, NA ; Boyd, LA (ELSEVIER SCI LTD, 2017)
    UNLABELLED: To build an understanding of the neurobiology underpinning arm recovery in people with severe arm impairment due to stroke, we conducted a pooled individual data systematic review to: 1) characterize brain biomarkers; 2) determine relationship(s) between biomarkers and motor outcome; and 3) establish relationship(s) between biomarkers and motor recovery. Three electronic databases were searched up to October 2, 2015. Eligible studies included adults with severe arm impairment after stroke. Descriptive statistics were calculated to characterize brain biomarkers, and pooling of individual patient data was performed using mixed-effects linear regression to examine relationships between brain biomarkers and motor outcome and recovery. Thirty-eight articles including individual data from 372 people with severe arm impairment were analysed. The majority of individuals were in the chronic (> 6 months) phase post stroke (51%) and had a subcortical stroke (49%). The presence of a motor evoked potential (indexed by transcranial magnetic stimulation) was the only biomarker related to better motor outcome (p = 0.02). There was no relationship between motor outcome and stroke volume (cm3), location (cortical, subcortical, mixed) or side (left vs. right), and corticospinal tract asymmetry index (extracted from diffusion weighted imaging). Only one study had longitudinal data, thus no data pooling was possible to address change over time (preventing our third objective). Based on the available evidence, motor evoked potentials at rest were the only biomarker that predicted motor outcome in individuals with severe arm impairment following stroke. Given that few biomarkers emerged, this review highlights the need to move beyond currently known biomarkers and identify new indices with sufficient variability and sensitivity to guide recovery models in individuals with severe motor impairments following stroke. PROSPERO: CRD42015026107.
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    Validity of Multisensor Array for Measuring Energy Expenditure of an Activity Bout in Early Stroke Survivors
    Kramer, SF ; Johnson, L ; Bernhardt, J ; Cumming, T (HINDAWI LTD, 2018)
    Introduction. Stroke survivors use more energy than healthy people during activities such as walking, which has consequences for the way exercise is prescribed for stroke survivors. There is a need for wearable device that can validly measure energy expenditure (EE) of activity to inform exercise prescription early after stroke. We aimed to determine the validity and reliability of the SenseWear-Armband (SWA) to measure EE and step-counts during activity <1 month after stroke. Materials and Methods. EE was measured using the SWA and metabolic cart and steps-counts were measured using the SWA and direct observation. Based on walking ability, participants performed 2x six-minute walks or repeated sit-to-stands. Concurrent validity and test-retest reliability were determined by calculating intraclass and concordance correlation coefficients. Results and Discussion. Thirteen participants walked; nine performed sit-to-stands. Validity of the SWA measuring EE for both activities was poor (ICC/CCC < 0.40). The SWA overestimates EE during walking and underestimated EE during sit-to-stands. Test-retest agreement showed an ICC/CCC of <0.40 and >0.75 for walking and sit-to-stand, respectively. However, agreement levels changed with increasing EE levels (i.e., proportional bias). The SWA did not accurately measure step-counts. Conclusion. The SWA should be used with caution to measure EE of activity of mild to moderate stroke survivors <1 month after stroke.
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    Characterising Arm Recovery in People with Severe Stroke (CARPSS): protocol for a 12-month observational study of clinical, neuroimaging and neurophysiological biomarkers
    Hayward, KS ; Lohse, KR ; Bernhardt, J ; Lang, CE ; Boyd, LA (BMJ PUBLISHING GROUP, 2018-11)
    INTRODUCTION: In individuals with early (indexed ≤7 days poststroke) and severe upper limb paresis (shoulder abduction and finger extension score of <5 out of 10), our objectives are to: (1) determine if biomarkers of brain structure and function collected at <1 month poststroke explain who will experience clinically important recovery over the first 12 months poststroke; (2) compare stroke survivors' perceptions of personally meaningful recovery to clinically important recovery; and (3) characterise the trajectory of change in measures of motor function, brain structure and function. METHODS AND ANALYSIS: Prospective observational study with an inception cohort of 78 first-time stroke survivors. Participants will be recruited from a single, large tertiary stroke referral centre. Clinical and biomarker assessments will be completed at four follow-up time points: 2 to 4 weeks and 3, 6 and 12 months poststroke. Our primary outcome is achievement of clinically important improvement on two out of three measures that span impairment (Fugl-Meyer Upper Limb, change ≥10 points), activity (Motor Assessment Scale item 6, change ≥1 point) and participation (Rating of Everyday Arm-use in the Community and Home, change ≥1 point). Brain biomarkers of structure and function will be indexed using transcranial magnetic stimulation and MRI. Multilevel modelling will be performed to examine the relationship between clinically important recovery achieved (yes/no) and a priori defined brain biomarkers related to the corticospinal tract and corpus callosum. Secondary analyses will compare stroke survivor's perception of recovery, as well as real-world arm use via accelerometry, to the proposed metric of clinically meaningful recovery; and model trajectory of recovery across clinical, a priori defined biomarkers and exploratory variables related to functional connectivity. ETHICS AND DISSEMINATION: Approved by the hospital and university ethics review boards. Results will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02464085.
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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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    How are early post-stroke exercise interventions developed? A systematic review
    Kramer, S ; Kaffenberger, T ; Cumming, T ; Bernhardt, J ; Johnson, L (SAGE PUBLICATIONS LTD, 2018-08)
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    What is the relationship between physical activity and cardiovascular risk factors in stroke survivors post completion of rehabilitation? Protocol for a longitudinal study
    Fini, NA ; Bernhardt, J ; Holland, AE (BMJ PUBLISHING GROUP, 2017-11)
    INTRODUCTION: Physical activity (PA) can modify cardiovascular and other health risks in people with stroke, but we know little about long-term PA in this group. This study aims to describe PA levels and investigate relationships between PA, cardiovascular risk factors, mobility and participant characteristics (eg, age, mood and fatigue) in the 2 years following rehabilitation discharge after first stroke. METHODS AND ANALYSIS: This is a longitudinal observational study with follow-up at 6, 12 and 24 months after rehabilitation discharge. Inclusion criteria are broad; excluding only those with previous stroke, palliative diagnosis, living more than 2 hours from the centre or admitted less than 5 days.The primary outcome of interest is duration of moderate to vigorous PA (min/day) measured by the Sensewear MF Armband (SWAB). Secondary outcomes include other PA measures measured with the SWAB; cardiovascular risk factors (eg, systolic blood pressure, fasting lipid profile and smoking status), mobility (10 m walk test), the Hospital Anxiety and Depression Scale and the Fatigue Severity Scale. All outcomes, except blood tests, are gathered at each time point.The target sample size is 77. We will explore associations between PA levels, cardiovascular risk factors, mobility and participant characteristics at baseline compared with 6, 12 and 24 months using random-effects regression modelling.The long-term PA of stroke survivors is largely unknown. We hope to identify factors that influence PA and cardiovascular risk in this population, which may help health professionals target the stroke survivors most at risk and implement appropriate treatment, preventative strategies and education. ETHICS AND DISSEMINATION: Approval was granted from Alfred Hospital and La Trobe University Research Ethics Committees. The study results will be disseminated in a number of ways including journal publication and international conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12613000196741.
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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.