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      ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’

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          Abstract

          Introduction

          Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in those who do not recover functional movement in the stroke affected arm are at risk of atrophy and contractures, which can be established as early as 6 weeks following stroke. Pain is also common. This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb.

          Methods and analysis

          This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72 h after stroke. Participants will be randomised to receive usual care or usual care and early ES to the wrist flexors and extensors for 30 min twice a day, 5 days a week for 3 months. The initial treatment(s) will be delivered by an occupational therapist or physiotherapist who will then train the patient and/or their nominated carer to self-manage subsequent treatments.

          Ethics and dissemination

          This study has been granted ethical approval by the National Research Ethics Service, East Midlands Nottingham1 Research Ethics Committee (ref: 15/EM/0006). To our knowledge, this is the first study of its kind of the early application (within 72 h post-stroke) of ES to both the wrist extensors and wrist flexors of stroke survivors with upper limb impairment. The results will inform the design of a definitive randomised controlled trial. Dissemination will include 2 peer-reviewed journal publications and presentations at national conferences.

          Trial registration number

          ISRCTN1648908; Pre-results. Clinicaltrials.gov ID: NCT02324634.

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          Most cited references19

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          Cerebral vascular accidents in patients over the age of 60. II. Prognosis.

          J. Rankin (1957)
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            Development of a stroke-specific quality of life scale.

            Clinical stroke trials are increasingly measuring patient-centered outcomes such as functional status and health-related quality of life (HRQOL). No stroke-specific HRQOL measure is currently available. This study presents the initial development of a valid, reliable, and responsive stroke-specific quality of life (SS-QOL) measure, for use in stroke trials. Domains and items for the SS-QOL were developed from patient interviews. The SS-QOL, Short Form 36, Beck Depression Inventory, National Institutes of Health Stroke Scale, and Barthel Index were administered to patients 1 and 3 months after ischemic stroke. Items were eliminated with the use of standard psychometric criteria. Construct validity was assessed by comparing domain scores with similar domains of established measures. Domain responsiveness was assessed with standardized effect sizes. All 12 domains of the SS-QOL were unidimensional. In the final 49-item scale, all domains demonstrated excellent internal reliability (Cronbach's alpha values for each domain >/=0.73). Most domains were moderately correlated with similar domains of established outcome measures (r2 range, 0.3 to 0.5). Most domains were responsive to change (standardized effect sizes >0.4). One- and 3-month SS-QOL scores were associated with patients' self-report of HRQOL compared with before their stroke (P<0.001). The SS-QOL measures HRQOL, its primary underlying construct, in stroke patients. Preliminary results regarding the reliability, validity, and responsiveness of the SS-QOL are encouraging. Further studies in diverse stroke populations are needed.
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              Recovery of motor function after stroke.

              The natural history of recovery of motor function after stroke is described using data from a 1-year community-based study in Auckland, New Zealand. Of 680 patients, 88% presented with a hemiparesis; the proportion of survivors with a persisting deficit declined to 71% at 1 month and 62% at 6 months after the onset of the stroke. At onset, there were equal proportions of people with mild, moderate, and severe motor deficits, but the majority (76%) of those who survived 6 months had either no or only a mild deficit. Recovery of motor function was associated with the stroke severity but not with age or sex; patients with a mild motor deficit at onset were 10 times more likely to recover their motor function than those with a severe stroke. Our results confirm the reasonably optimistic outcome for survivors of stroke and further suggest that recovery of motor function is confined to patients whose motor deficit at onset is either mild or moderate.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2016
                04 January 2016
                : 6
                : 1
                : e010079
                Affiliations
                [1 ]Faculty of Medicine and Health Sciences, University of Nottingham , Nottingham, UK
                [2 ]Faculty of Health Sciences, University of Southampton , Southampton, UK
                [3 ]Sheffield, UK
                [4 ]Research Design Service East Midlands, University of Nottingham , Nottingham, UK
                [5 ]School of Health and rehabilitation, Keele University , Keele, UK
                Author notes
                [Correspondence to ] Dr Joanna Fletcher-Smith; joanna.fletcher-smith@ 123456nottingham.ac.uk
                Article
                bmjopen-2015-010079
                10.1136/bmjopen-2015-010079
                4716194
                26729394
                4b6e98fb-9e9b-41e0-ba97-d64068ca774d
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                : 24 September 2015
                : 14 October 2015
                Categories
                Rehabilitation Medicine
                Protocol
                1506
                1727
                1713

                Medicine
                qualitative research,pain management,occupational therapy
                Medicine
                qualitative research, pain management, occupational therapy

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