Study protocol of ‘Prism Adaptation in Rehabilitation’: a randomized controlled trial in stroke patients with neglect
Identifieur interne : 000530 ( Main/Exploration ); précédent : 000529; suivant : 000531Study protocol of ‘Prism Adaptation in Rehabilitation’: a randomized controlled trial in stroke patients with neglect
Auteurs : Antonia F. Ten Brink [Pays-Bas] ; Johanna Ma Visser-Meily [Pays-Bas] ; Tanja Cw Nijboer [Pays-Bas]Source :
- BMC Neurology [ 1471-2377 ] ; 2015.
Abstract
A frequent disorder after stroke is neglect, resulting in a failure to report or respond to contralesional stimuli. Rehabilitation of neglect is important, given the negative influence on motor recovery, independence in self-care, transfers, and locomotion. Effects of prism adaptation (PA) to alleviate neglect have been reported. However, either small groups or no control group were included and few studies reported outcome measurements on the level of activities of daily living (ADL). The current ongoing RCT investigates the short- and long-term effects of PA in a large population in a realistic clinical setting. Measures range from the level of function to the level of ADL.
Neglect patients in the sub-acute phase after stroke are randomly assigned to PA (n = 35) or sham adaptation (SA; n = 35). Adaptation is performed for 10 consecutive weekdays. Patients are tested at start of the study, 1 and 2 weeks after starting, and 1, 2, 4 and 12 weeks after ending treatment. Primary objectives are changes in performance on neuropsychological tests and neglect in ADL. Secondary objectives are changes in simulated driving, eye movements, balance, visual scanning and mobility, subjective experience of neglect in ADL and independence during ADL.
If effective, PA could be implemented as a treatment for neglect.
This trial is registered at the Dutch Trial Register #
Url:
DOI: 10.1186/s12883-015-0263-y
PubMed: 25648350
PubMed Central: 4326203
Affiliations:
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Ten Brink</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht</wicri:regionArea><wicri:noRegion>3583 TM Utrecht</wicri:noRegion></affiliation></author><author><name sortKey="Visser Meily, Johanna Ma" sort="Visser Meily, Johanna Ma" uniqKey="Visser Meily J" first="Johanna Ma" last="Visser-Meily">Johanna Ma Visser-Meily</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht</wicri:regionArea><wicri:noRegion>3583 TM Utrecht</wicri:noRegion></affiliation></author><author><name sortKey="Nijboer, Tanja Cw" sort="Nijboer, Tanja Cw" uniqKey="Nijboer T" first="Tanja Cw" last="Nijboer">Tanja Cw Nijboer</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht</wicri:regionArea><wicri:noRegion>3583 TM Utrecht</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:aff id="Aff2">Department of Experimental Psychology, Helmholtz Institute, Utrecht University, Heidelberglaan 1, 3584 CS Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Experimental Psychology, Helmholtz Institute, Utrecht University, Heidelberglaan 1, 3584 CS Utrecht</wicri:regionArea><orgName type="university">Université d'Utrecht</orgName><placeName><settlement type="city">Utrecht</settlement><region nuts="2">Utrecht (province)</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25648350</idno><idno type="pmc">4326203</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326203</idno><idno type="RBID">PMC:4326203</idno><idno type="doi">10.1186/s12883-015-0263-y</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000753</idno><idno type="wicri:Area/Pmc/Curation">000753</idno><idno type="wicri:Area/Pmc/Checkpoint">000313</idno><idno type="wicri:Area/Ncbi/Merge">003666</idno><idno type="wicri:Area/Ncbi/Curation">003666</idno><idno type="wicri:Area/Ncbi/Checkpoint">003666</idno><idno type="wicri:Area/Main/Merge">000530</idno><idno type="wicri:Area/Main/Curation">000530</idno><idno type="wicri:Area/Main/Exploration">000530</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Study protocol of ‘Prism Adaptation in Rehabilitation’: a randomized controlled trial in stroke patients with neglect</title><author><name sortKey="Ten Brink, Antonia F" sort="Ten Brink, Antonia F" uniqKey="Ten Brink A" first="Antonia F" last="Ten Brink">Antonia F. Ten Brink</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht</wicri:regionArea><wicri:noRegion>3583 TM Utrecht</wicri:noRegion></affiliation></author><author><name sortKey="Visser Meily, Johanna Ma" sort="Visser Meily, Johanna Ma" uniqKey="Visser Meily J" first="Johanna Ma" last="Visser-Meily">Johanna Ma Visser-Meily</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht</wicri:regionArea><wicri:noRegion>3583 TM Utrecht</wicri:noRegion></affiliation></author><author><name sortKey="Nijboer, Tanja Cw" sort="Nijboer, Tanja Cw" uniqKey="Nijboer T" first="Tanja Cw" last="Nijboer">Tanja Cw Nijboer</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Rembrandtkade 10, 3583 TM Utrecht</wicri:regionArea><wicri:noRegion>3583 TM Utrecht</wicri:noRegion></affiliation><affiliation wicri:level="4"><nlm:aff id="Aff2">Department of Experimental Psychology, Helmholtz Institute, Utrecht University, Heidelberglaan 1, 3584 CS Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Experimental Psychology, Helmholtz Institute, Utrecht University, Heidelberglaan 1, 3584 CS Utrecht</wicri:regionArea><orgName type="university">Université d'Utrecht</orgName><placeName><settlement type="city">Utrecht</settlement><region nuts="2">Utrecht (province)</region></placeName></affiliation></author></analytic><series><title level="j">BMC Neurology</title><idno type="eISSN">1471-2377</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>A frequent disorder after stroke is neglect, resulting in a failure to report or respond to contralesional stimuli. Rehabilitation of neglect is important, given the negative influence on motor recovery, independence in self-care, transfers, and locomotion. Effects of prism adaptation (PA) to alleviate neglect have been reported. However, either small groups or no control group were included and few studies reported outcome measurements on the level of activities of daily living (ADL). The current ongoing RCT investigates the short- and long-term effects of PA in a large population in a realistic clinical setting. Measures range from the level of function to the level of ADL.</p></sec><sec><title>Methods/Design</title><p>Neglect patients in the sub-acute phase after stroke are randomly assigned to PA (n = 35) or sham adaptation (SA; n = 35). Adaptation is performed for 10 consecutive weekdays. Patients are tested at start of the study, 1 and 2 weeks after starting, and 1, 2, 4 and 12 weeks after ending treatment. Primary objectives are changes in performance on neuropsychological tests and neglect in ADL. Secondary objectives are changes in simulated driving, eye movements, balance, visual scanning and mobility, subjective experience of neglect in ADL and independence during ADL.</p></sec><sec><title>Discussion</title><p>If effective, PA could be implemented as a treatment for neglect.</p></sec><sec><title>Trial registration</title><p>This trial is registered at the Dutch Trial Register #<ext-link ext-link-type="uri" xlink:href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3278">NTR3278</ext-link>.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Appelros, P" uniqKey="Appelros P">P Appelros</name></author><author><name sortKey="Karlsson, Gm" uniqKey="Karlsson G">GM Karlsson</name></author><author><name sortKey="Seiger, A" uniqKey="Seiger A">A Seiger</name></author><author><name sortKey="Nydevik, I" uniqKey="Nydevik I">I Nydevik</name></author></analytic></biblStruct><biblStruct><analytic><author><name 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Nes</name></author><author><name sortKey="Geurts, Ach" uniqKey="Geurts A">ACH Geurts</name></author><author><name sortKey="Brouwer, Wh" uniqKey="Brouwer W">WH Brouwer</name></author><author><name sortKey="Fasotti, L" uniqKey="Fasotti L">L Fasotti</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Verlander, D" uniqKey="Verlander D">D Verlander</name></author><author><name sortKey="Hayes, A" uniqKey="Hayes A">A Hayes</name></author><author><name sortKey="Mcinnes, Jk" uniqKey="Mcinnes J">JK McInnes</name></author><author><name sortKey="Liddle, Rj" uniqKey="Liddle R">RJ Liddle</name></author><author><name sortKey="Liddle, Gw" uniqKey="Liddle G">GW Liddle</name></author><author><name sortKey="Clarke, Ge" uniqKey="Clarke G">GE Clarke</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Collin, C" uniqKey="Collin C">C Collin</name></author><author><name sortKey="Wade, D" uniqKey="Wade D">D Wade</name></author><author><name 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Ten Brink</name></noRegion><name sortKey="Nijboer, Tanja Cw" sort="Nijboer, Tanja Cw" uniqKey="Nijboer T" first="Tanja Cw" last="Nijboer">Tanja Cw Nijboer</name><name sortKey="Nijboer, Tanja Cw" sort="Nijboer, Tanja Cw" uniqKey="Nijboer T" first="Tanja Cw" last="Nijboer">Tanja Cw Nijboer</name><name sortKey="Visser Meily, Johanna Ma" sort="Visser Meily, Johanna Ma" uniqKey="Visser Meily J" first="Johanna Ma" last="Visser-Meily">Johanna Ma Visser-Meily</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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}}
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