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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

Thu, 01 Nov 2018 00:00:00 GMT

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 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.

The personal and social experiences of community-dwelling younger adults after stroke in Australia: a qualitative interview study

Sat, 01 Dec 2018 00:00:00 GMT

The personal and social experiences of community-dwelling younger adults after stroke in Australia: a qualitative interview study Shipley, J; Luker, J; Thijs, V; Bernhardt, J OBJECTIVES: To examine the personal and social experiences of younger adults after stroke. DESIGN: Qualitative study design involving in-depth semi-structured interviews and rigorous qualitative descriptive analysis informed by social constructionism. PARTICIPANTS: Nineteen younger stroke survivors aged 18 to 55 years at the time of their first-ever stroke. SETTING: Participants were recruited from urban and rural settings across Australia. Interviews took place in a clinic room of the Florey Institute of Neuroscience and Mental Health (Melbourne, Australia), over an online conference platform or by telephone. RESULTS: Four main themes emerged from the discourses: (1) psycho-emotional experiences after young stroke; (2) losing pre-stroke life construct and relationships; (3) recovering and adapting after young stroke; and (4) invalidated by the old-age, physical concept of stroke. While these themes ran through the narratives of all participants, data analysis also drew out interesting variation between individual experiences. CONCLUSIONS: For many younger adults, stroke is an unexpected and devastating life event that profoundly diverts their biography and presents complex and continued challenges to fulfilling age-normative roles. While adaptation, resilience and post-traumatic growth are common, this study suggests that more bespoke support is needed for younger adults after stroke. Increasing public awareness of young stroke is also important, as is increased research attention to this problem.

Breaking up sitting time after stroke - How much less sitting is needed to improve blood pressure after stroke (BUST-BP-Dose): Protocol for a dose-finding study

Fri, 01 Mar 2019 00:00:00 GMT

Breaking up sitting time after stroke - How much less sitting is needed to improve blood pressure after stroke (BUST-BP-Dose): Protocol for a dose-finding study Mackie, P; Crowfoot, G; Janssen, H; Dunstan, DW; Bernhardt, J; Walker, FR; Patterson, A; Callister, R; Spratt, NJ; Holliday, E; English, C Excessive sitting is detrimentally associated with cardiovascular disease and all-cause mortality. Frequent breaks in prolonged sitting can improve cardiometabolic responses in non-stroke populations. However, this has not been established in stroke survivors. This study will determine the most effective dose of activity breaks that (i) produce clinically meaningful improvements in mean systolic blood pressure (primary outcome), postprandial glucose, and insulin responses (secondary outcomes), and (ii) is safe and feasible. We hypothesis that systolic blood pressure, postprandial insulin, and glucose responses will improve with increasing doses of activity and be most effective at the maximum safe and feasible dose of activity. Thirty participants in the most effective dose will provide 80% power to detect a within-person, between-condition, difference of 3.5 mmHg in systolic blood pressure assuming a SD of 15 mmHg, within-person correlation of 0.9, and α = 0.05. Stroke survivors will complete 3 experimental conditions in a within-participant, dose escalation design including (i) uninterrupted sitting (8 h), (ii) Dose 1: uninterrupted sitting with bouts of light-intensity exercises while standing (initial dose involves two 5-min breaks), and (iii) Dose 2: two additional 5-min breaks above Dose 1. Ambulatory blood pressure will be collected every 30 min during experimental conditions and hourly for 24-h post-experimental conditions. Blood samples will be collected every 30 min during 2-h postprandial periods. This study will identify the most effective dose of light-intensity exercises while standing to improve cardiometabolic responses in stroke survivors.

Economic evaluation of a phase III international randomised controlled trial of very early mobilisation after stroke (AVERT)

Wed, 01 May 2019 00:00:00 GMT

Economic evaluation of a phase III international randomised controlled trial of very early mobilisation after stroke (AVERT) Gao, L; Sheppard, L; Wu, O; Churilov, L; Mohebbi, M; Collier, J; Bernhardt, J; Ellery, F; Dewey, H; Moodie, M 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.