Characterising Arm Recovery in People with Severe Stroke (CARPSS): protocol for a 12-month observational study of clinical, neuroimaging and neurophysiological biomarkers.
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ABSTRACT: 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.
SUBMITTER: Hayward KS
PROVIDER: S-EPMC6254492 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
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