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      Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): A randomized controlled trial

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          Abstract

          Background and purpose

          We designed an 8-week caregiver-mediated exercise program with e-health support after stroke (CARE4STROKE) in addition to usual care with the aim to improve functional outcome and to facilitate early supported discharge by increasing the intensity of task specific training.

          Methods

          An observer-blinded randomized controlled trial in which 66 stroke patient-caregiver couples were included during inpatient rehabilitation. Patients allocated to the CARE4STROKE program trained an additional amount of 150 minutes a week with a caregiver and were compared to a control group that received usual care alone. Primary outcomes: self-reported mobility domain of the Stroke Impact Scale 3.0 (SIS) and length of stay (LOS). Secondary outcomes: motor impairment, strength, walking ability, balance, mobility and (Extended) Activities of Daily Living of patients, caregiver strain of caregivers, and mood, self-efficacy, fatigue and quality of life of both patients and caregivers. Outcomes were assessed at baseline, 8 and 12 weeks after randomization.

          Results

          No significant between-group differences were found regarding SIS-mobility after 8 (β 6.21, SD 5.16; P = 0.229) and 12 weeks (β 0.14, SD 2.87; P = 0.961), and LOS ( P = 0.818). Significant effects in favor of the intervention group were found for patient’s anxiety (β 2.01, SD 0.88; P = 0.023) and caregiver’s depression (β 2.33, SD 0.77; P = 0.003) post intervention. Decreased anxiety in patients remained significant at the 12-week follow-up (β 1.01, SD 0.40; P = 0.009).

          Conclusions

          This proof-of concept trial did not find significant effects on both primary outcomes mobility and LOS as well as the secondary functional outcomes. Treatment contrast in terms of total exercise time may have been insufficient to achieve these effects. However, caregiver-mediated exercises showed a favorable impact on secondary outcome measures of mood for both patient and caregiver.

          Clinical trial registration

          NTR4300, URL– http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4300.

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          Most cited references35

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          Stroke--1989. Recommendations on stroke prevention, diagnosis, and therapy. Report of the WHO Task Force on Stroke and other Cerebrovascular Disorders.

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            Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale.

            To assess multiple psychometric characteristics of a new stroke outcome measure, the Stroke Impact Scale (SIS), using Rasch analysis, and to identify and remove misfitting items from the 8 domains that comprise the SIS. Secondary analysis of 3-month outcomes for the Glycine Antagonist in Neuroprotection (GAIN) Americas randomized stroke trial. A multicenter randomized trial performed in 132 centers in the United States and Canada. A total of 696 individuals with stroke who were community-dwelling and independent prior to acute stroke. Not applicable. Rasch analysis was performed using WINSTEPS, version 3.31, to evaluate 4 psychometric characteristics of the SIS: (1) unidimensionality or fit (the extent to which items measure a single construct), (2) targeting (the extent to which the items are of appropriate difficulty for the sample), (3) item difficulty (the ordering of items from least to most difficult to perform), and (4) separation (the extent to which the items distinguish distinct levels of functioning within the sample). (1) Within each domain, most of the items measured a single construct. Only 3 items misfit the constructs and were deleted ("add and subtract numbers," "get up from a chair," "feel emotionally connected") and 2 items ("handle money," "manage money") misfit the combined physical domain. These items were deleted to create SIS, version 3.0. (2) Overall, the items are well targeted to the sample. The physical and participation domains have a wide range of items that capture difficulties that most individuals with stroke experience in physical and role functions, while the memory, emotion, and communication domains include items that capture limitations in the most impaired patients. (3) The order of items from less to more difficult was clinically meaningful. (4) The individual physical domains differentiated at least 3 (high, average, low) levels of functioning and the composite physical domain differentiated more than 4 levels of functioning. However, because difficulties with communication, memory, and emotion were not as frequently reported and difficulties with hand function were more frequently reported, these domains only differentiated 2 (high, low) to 3 (high, average, low) strata of patients. Time from stroke onset to administration of the SIS had little effect on item functioning. Rasch analysis further established the validity of the SIS. The domains are unidimensional, the items have an excellent range of difficulty, and the domain scores differentiated patients into multiple strata. The activities of daily living/instrumental activities of daily living, mobility, strength, composite physical, and participation domains have the most robust psychometric characteristics. The composite physical domain is most able to discriminate difficulty in function in individuals after stroke, while the communication, memory, and emotion domain items only capture limitations in function in the more impaired groups of patients.
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              Standardized measurement of sensorimotor recovery in stroke trials: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.

              Finding, testing and demonstrating efficacy of new treatments for stroke recovery is a multifaceted challenge. We believe that to advance the field, neurorehabilitation trials need a conceptually rigorous starting framework. An essential first step is to agree on definitions of sensorimotor recovery and on measures consistent with these definitions. Such standardization would allow pooling of participant data across studies and institutions aiding meta-analyses of completed trials, more detailed exploration of recovery profiles of our patients and the generation of new hypotheses. Here, we present the results of a consensus meeting about measurement standards and patient characteristics that we suggest should be collected in all future stroke recovery trials. Recommendations are made considering time post stroke and are aligned with the international classification of functioning and disability. A strong case is made for addition of kinematic and kinetic movement quantification. Further work is being undertaken by our group to form consensus on clinical predictors and pre-stroke clinical data that should be collected, as well as recommendations for additional outcome measurement tools. To improve stroke recovery trials, we urge the research community to consider adopting our recommendations in their trial design.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: Project administrationRole: Writing – review & editing
                Role: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: Writing – review & editing
                Role: ResourcesRole: Writing – review & editing
                Role: ResourcesRole: Writing – review & editing
                Role: MethodologyRole: ResourcesRole: Writing – review & editing
                Role: Formal analysisRole: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: Funding acquisitionRole: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: Funding acquisitionRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                8 April 2019
                2019
                : 14
                : 4
                : e0214241
                Affiliations
                [1 ] Amsterdam Rehabilitation Research Centre, Reade, Amsterdam, The Netherlands
                [2 ] Department of Rehabilitation Medicine, Amsterdam Neuroscience and Amsterdam Movement Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
                [3 ] AptaVivar, Hengelo, The Netherlands
                [4 ] Department of General Practice and Elderly Care Medicine and the EMGO Institute for Health and Care Research, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
                [5 ] Department of Health Sciences & Amsterdam Movement Sciences, Faculty of Science, VU University, Amsterdam, The Netherlands
                [6 ] Department of Physiotherapy & Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark
                [7 ] Department of Physical Therapy and Human Movement Sciences, Northwestern University, Evanston, IL, United States of America
                University of Glasgow, UNITED KINGDOM
                Author notes

                Competing Interests: We have the following interests. Henry Mulder is employed by AptaVivar. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

                Author information
                http://orcid.org/0000-0002-1460-4660
                http://orcid.org/0000-0002-7845-5799
                Article
                PONE-D-18-31640
                10.1371/journal.pone.0214241
                6453481
                30958833
                030af082-4f26-4df6-a10b-bfc97b486789
                © 2019 Vloothuis et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 3 November 2018
                : 8 March 2019
                Page count
                Figures: 2, Tables: 1, Pages: 14
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100001826, ZonMw;
                Award ID: 837001408
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100001826, ZonMw;
                Award ID: 606300098012
                Award Recipient :
                This study was funded by the Netherlands Organization of Health Research and Development (ZonMW - www.zonmw.nl) grant number 837001408 (2013) and grant number 606300098012 (2015) Both grants were awarded to GK and EvW. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. AptaVivar provided support in the form of salary for author HM, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of this author are articulated in the ‘author contributions’ section.
                Categories
                Research Article
                Medicine and Health Sciences
                Complementary and Alternative Medicine
                Exercise Therapy
                Medicine and Health Sciences
                Public and Occupational Health
                Physical Activity
                Physical Fitness
                Exercise
                Medicine and Health Sciences
                Sports and Exercise Medicine
                Exercise
                Biology and Life Sciences
                Sports Science
                Sports and Exercise Medicine
                Exercise
                Biology and Life Sciences
                Psychology
                Emotions
                Anxiety
                Social Sciences
                Psychology
                Emotions
                Anxiety
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Mood Disorders
                Depression
                Medicine and Health Sciences
                Health Care
                Patients
                Medicine and Health Sciences
                Health Care
                Physiotherapy
                Medicine and Health Sciences
                Sports and Exercise Medicine
                Biology and Life Sciences
                Sports Science
                Sports and Exercise Medicine
                Medicine and Health Sciences
                Neurology
                Cerebrovascular Diseases
                Stroke
                Hemorrhagic Stroke
                Medicine and Health Sciences
                Vascular Medicine
                Stroke
                Hemorrhagic Stroke
                Custom metadata
                All relevant data are within the manuscript and its Supporting Information files.

                Uncategorized
                Uncategorized

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