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The effect of an enriched environment on activity levels in people with stroke in an acute stroke unit:… Rosbergen, Ingrid C M; Grimley, Rohan S; Hayward, Kathryn S; Walker, Katrina C; Rowley, Donna; Campbell, Alana M; McGufficke, Suzanne; Robertson, Samantha T; Trinder, Janelle; Janssen, Heidi; Brauer, Sandra G Aug 2, 2016

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STUDY PROTOCOL Open AccessThe effect of an enriched environment onactivity levels in people with stroke in anacute stroke unit: protocol for a before-afterpilot studyIngrid C. M. Rosbergen1,2*, Rohan S. Grimley3, Kathryn S. Hayward1,4, Katrina C. Walker2, Donna Rowley5,Alana M. Campbell2, Suzanne McGufficke2, Samantha T. Robertson2, Janelle Trinder5, Heidi Janssen6and Sandra G. Brauer1AbstractBackground: Clinical practice guidelines advocate engaging stroke survivors in as much activity as possible earlyafter stroke. One approach found to increase activity levels during inpatient rehabilitation incorporated an enrichedenvironment (EE), whereby physical, cognitive, and social activity was enhanced. The effect of an EE in an acutestroke unit (ASU) has yet not been explored.Methods/design: We will perform a prospective non-randomized before-after intervention study. The primary aimis to determine if an EE can increase physical, social, and cognitive activity levels of people with stroke in an ASUcompared to usual care. Secondary aims are to determine if fewer secondary complications and improved functionaloutcomes occur within an EE. We will recruit 30 people with stroke to the usual care block and subsequently 30 to theEE block. Participants will be recruited within 24–72 h after onset of stroke, and each block is estimated to last for12 weeks. In the usual care block current management and rehabilitation within an ASU will occur. In the EE block, theASU environment will be adapted to promote greater physical, social, and cognitive activity. Three months after the EEblock, another 30 participants will be recruited to determine sustainability of this intervention. The primary outcome ischange in activity levels measured using behavioral mapping over 12 h (7.30 am to 7.30 pm) across two weekdays andone weekend day within the first 10 days of admission. Secondary outcomes include functional outcome measures,adverse and serious adverse events, stroke survivor, and clinical staff experience.Discussion: There is a need for effective interventions that starts directly in the ASU. The EE is an innovativeintervention that could increase activity levels in stroke survivors across all domains and promote early recoveryof stroke survivors in the acute setting.Trial registration: Australian New Zealand Clinical Trial Registry, ANZCTN12614000679684Keywords: Stroke, Acute stroke unit, Enriched environment, Activity, Behavioral mapping, Complications* Correspondence: Ingrid.rosbergen@health.qld.gov.au1Division of Physiotherapy, School of Health and Rehabilitation Sciences,University of Queensland, Brisbane, Australia2Allied Health Services, Nambour General Hospital, Sunshine Coast Hospitaland Health Service, PO Box 547, Nambour 4560, AustraliaFull list of author information is available at the end of the article© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Rosbergen et al. Pilot and Feasibility Studies  (2016) 2:36 DOI 10.1186/s40814-016-0081-zBackgroundStroke survivors who receive care in an acute stroke unit(ASU) are more likely to be alive and independent com-pared with general ward care [1]. Characteristics of theASU considered to contribute to these outcomes includeearly mobility and multidisciplinary coordinated rehabili-tation [2] to prevent immobility-related complications[3] and commence functional recovery early after stroke.Strong evidence indicates that increased engagement inphysical activities targeting mobility and arm-hand func-tion early after stroke result in improved functional out-comes [4]. Yet, despite awareness of the positive effectsof increased physical activity, available evidence indicatesthat stroke survivors spend the majority of the day phys-ically inactive and alone early after stroke [5].Social support has been recognized as an importantdeterminant of health-related quality of life in stroke sur-vivors [6]. The relationship between various types of socialsupport such as emotional, instrumental, or informationalsupport and quality of life is inconsistent [6]. Some studieshave found that high levels of social support are associatedwith larger improvements in functional status [7, 8]. It isargued that social support can offer encouragement, as-sistance, and increase compliance with treatments [7, 9]and assist in dealing with the consequences of stroke [6].However, not all aspects of social support may be bene-ficial; instrumental support may lead to poorer health ifsomeone becomes dependent on the provided assistance[10]. Limited evidence is available regarding cognitiveactivity after stroke. Cognitive activity such as listening tomusic during early recovery has been shown to enhancefocused attention [11], lessen depressed mood [11], andimprove visual attention in those with unilateral neglect[12]. Despite these possible benefits, little is known re-garding social and cognitive activity levels in stroke survi-vors early after stroke.There is a need to identify interventions that can increaseactivity levels across physical, social, and cognitive domainsand concurrently have a positive effect on outcomes earlyafter stroke. One possible intervention is an enrichedenvironment (EE). In animal research, an EE is definedas an organized stimulating environment to enhancesensory, motor, and cognitive activities [13]. A systematicreview and meta-analysis in animal research of stroke hasshown that an EE has a positive effect on physical re-covery, learning, and exploratory behavior, which includesreduced decline in memory and levels of anxiety [14]. Apilot study of EE in people with stroke was recently under-taken in the sub-acute inpatient rehabilitation setting [15].This study showed promising results, with increased activ-ity levels demonstrated across these activity domains [15].An EE was achieved within this study by creating com-munal areas with stimulating equipment and individualenrichment through provision of personal equipment suchas music and hobby activities [15]. An EE can provideactivities that are meaningful and tailored to each strokesurvivor as a wide variety of activities can be included inan enriched clinical setting. In addition, novel advancedtechnology such as virtual reality, IPads, and active gam-ing technologies can be a valuable addition to providestimulation to stroke survivors with a therapeutic effect[16–18]. Enrichment strategies with a more conventionalcharacter could involve music and art, as these activitieshave shown to reduce boredom and a positive effect onmood in stroke survivors [19, 20].Taken together, it is plausible that the implementationof an EE immediately post-stroke within an ASU couldpositively influence activity levels across all domains andlead to fewer complications and improved functional out-comes. This pilot study aims to determine the effect ofimplementing an EE in an ASU on physical, social, andcognitive activity levels, adverse events, and functionaloutcomes. We hypothesize that stroke survivors who starttheir journey in an ASU with an embedded EE will bemore active, experience fewer complications, and achievegreater functional outcomes compared to those who starttheir journey in an ASU without embedded EE.Methods/designThe study involves a prospective non-randomized beforeand after design. We will recruit 30 people with stroketo usual care (block 1) and subsequently 30 to EE inter-vention (block 2). We will evaluate activity levels acrossall domains, secondary complications, and functionaloutcomes within both blocks. Following block 1, we willembed an EE in the same ASU during a 6-week periodbefore commencement of block 2. To determine if em-bedding an EE within an ASU persists, activity levels willbe re-evaluated 3 months post-Block 2 (EE) with an add-itional 30 stroke participants.Participants and settingAll recruitment for this study will be conducted in the sameASU in a regional Australian acute hospital. The ASU is anendorsed unit with 470 stroke admissions per annum, anaverage acute length of stay of 4.1 days, and an in-hospitalmortality rate of 17 %. Rehabilitation by a multidisciplinaryteam is commenced on the day of admission, with transferto general inpatient rehabilitation units (public and private)if length of stay is predicted to be greater than 7–10 days.Several community-based rehabilitation services are avail-able spanning home and center based and slower transitioncare. The ASU has 8 funded stroke beds and is embeddedwithin a 16-bed ward (8 single rooms and 4 double rooms).The ward is supported by 2.0 fulltime equivalent (FTE)physiotherapists, 1.6 FTE occupational therapists, 1.0 FTEspeech therapist, 1.0 FTE social worker, 0.5 FTE dietician,and 0.7 FTE therapy assistant.Rosbergen et al. Pilot and Feasibility Studies  (2016) 2:36 Page 2 of 6All stroke survivors admitted to the hospital will bescreened for eligibility with consecutive recruitment ofeligible participants. Recruitment is estimated to occurover 12 weeks or until the target number is reached.Participants will be included if they are (1) admitted tothe ASU within 24–72 h after onset of stroke (ischemicor hemorrhagic, first and/or recurrent stroke), (2) ableto complete a transfer from bed to chair with assistanceof two persons or less, (3) able to follow single stagecommands, (4) requiring assistance for basic activities ofdaily living (ADLs), and (5) were able to walk independentlypremorbidly (functional ambulation category score ≥4) andhave a modified Rankin Score (mRS) of ≤2 from self-report.Participants will be excluded if they have (1) a retrospectivepremorbid mRS of ≥3, (2) a concurrent diagnosis of rapidlydeteriorating disease, or (3) have an extensive psychiatrichistory. To allow for observational data collection, strokesurvivors will also be excluded if discharge from the ASU islikely to occur within 2 days of admission. Informed con-sent will be obtained from participants or their substitutedecision maker. Participants will be informed that theproject aims to compare an alternative model of rehabi-litation with the traditional model of rehabilitation, but notinformed regarding the specific intervention being investi-gated or group allocation.Baseline measuresBaseline measures will include demographics; previousmRS and living arrangements; stroke details such as date,estimated time of onset, lesion location and type, OxfordStroke Classification, and National Institute of HealthStroke Scale (NIHSS). Stroke severity will be classifiedaccording to NIHSS [21] on admission (day 1 if thrombo-lyzed): mild (<8), moderate (8–16), and severe (>16).InterventionIn the 12-week usual care block, participants will receiveusual stroke management within the ASU and rehabilita-tion will be delivered in one-on-one interventions bytherapists to stroke participants. At this site, therapistshave access to a common therapy room, discipline-specific allied health assistants for individual treatmentsessions and equipment to increase practice. Staffinglevels will be monitored across the study period to en-sure that they remain consistent across blocks.After the usual care block, there will be a 6-week periodin which the environment of the ASU will be adapted.Several communal areas will be created on the wardwhere participants have access to stimulating equipment.Self-directed exercise programs, iPads loaded with apps,iPods loaded with music, books, board games, puzzles,magazines, newspapers, and music will be available duringand outside of therapy hours. During these 6 weeks, stafffocus towards enabling activity will be reinforced throughinterdisciplinary education sessions. At these sessions, theEE theoretical concept, EE intervention, and ‘enablers andbarriers’ of implementation of the intervention will beinteractively discussed [22]. We will educate staff to en-courage participants to attend communal areas and touse stimulating equipment in communal areas and atthe bedside. Allied health assistants will be trained fromdiscipline-specific to “generic” allied health assistantsfor the EE intervention. By doing this, all assistants willbe able to mobilize patients and assist all therapists. Inaddition to interdisciplinary education, we will appointnurse champions to facilitate and encourage adherenceto the intervention on a day-to-day basis.In the 12-week EE block, communal areas will be usedto enhance individual and group activities. A daily groupsession will focus on different aspects of stroke recoverysuch as education, emotional support, communication,and physical activities. On three weekdays, there will bean interactive breakfast, and every weekday, an interactivelunchtime will be organized. These interactive mealtimesare aimed to increase the frequency of mobilization, en-courage sitting upright for mealtimes, and stimulate socialinteraction. Staff present during mealtimes will facilitateindependence in consuming meals and encourage nutri-tional intake in participants. Participants will be encour-aged to voluntarily attend mealtimes without coercion forany activity. As total staffing numbers will not change withthe EE, any staff time in group/meal sessions will bediverted from previous 1:1 therapy time. Allied healthassistants will play the main role in managing mealtimes.Participants of the EE block will receive a brochurethat outlines the importance of frequent activity earlyafter stroke; advice about how families can be involvedand the day structure of the ASU will be explained. Toencourage family involvement, stimulating equipmentand individualized activity cards will be placed at theparticipant’s bedside tailored to the stroke survivor’sgoals. Family and staff will be advised to bring personalitems and hobby activities for the participant and toencourage the participant to engage in these activitiesoutside therapy hours and on weekends.Fidelity of the interventionDuring the EE intervention, we will monitor the occur-rence of mealtimes and group sessions, availability ofresources, and provision of information brochures. Ourmain measure for a successful implementation is to deter-mine if participants in the EE intervention demonstratesignificant higher activity levels as compared to usual careand that the EE is a safe intervention in the ASU.Primary outcomesActivity levels will be determined for 'any activity', physical,social, and cognitive activity and time spent alone. AnyRosbergen et al. Pilot and Feasibility Studies  (2016) 2:36 Page 3 of 6activity is defined as the stroke survivor performing at leastone physical, social, or cognitive activity or a combinationof activities in these domains [23]. Total activity will beexpressed as a percentage of the total number of observa-tions performed, as will activity within physical, social, andcognitive activity domains. The first 10 days after admissionwill be considered as the primary exposure profile.The behavioral mapping protocol by Janssen et al. [23]has been adapted for this study and will be used formeasuring activity. Protocol adaptation included incorp-orating typical activities and equipment utilized in theacute setting.Participants will be observed for 1-min at 10-min in-tervals from 7.30 am till 7.30 pm on two weekdays andone weekend day for a maximum of three mapping daysor until discharge from the ASU. For each observation,the main activity performed during 1-min will be re-corded for each category. In addition, we will report ifthe participant performed the observed activity inde-pendently, supervised, or with assistance. The partici-pant’s location, body position, and people present willalso be documented. Participants can be engaged in 'noactivity' and can perform activities across more than onedomain concurrently.During each observation, the observer will collect datafor as many categories as able. When the observer isunable to view the participant due to activity precludingdirect observation (e.g., participant is in the bathroom),an attempt will be made to retrospectively estimateactivity from nearby staff or the participant. Intervalswhere a participant is unable to be observed (e.g., off theward for investigations) or activity unable to be esti-mated will be classified as 'unobserved'. Unintentionalnon-observations will be classified as 'missing' data. Un-observed and missing data will not contribute to thetotal number of observations for a participant. The rea-son for and proportion of 'unobserved and missingobservations' will be reported by group.Staff performing behavioral mapping will have spe-cific training, followed by assessment compromisingobservation of four patients for 1 h, providing 24 obser-vations. Competency to record study data is defined asattaining ≥90 % agreement with concurrent observationsby the investigator. Behavioral mapping staff members willnot receive any study details.Secondary outcomesSecondary measures to be collected include functional out-comes, adverse and serious adverse events, and mood.Functional outcomes will be assessed with the mRS, modi-fied Barthel index (MBI), 10-m walk test, and MobilityScale for Acute Stroke patients (MSAS). Mood will beassessed with the Hospital Anxiety and Depression Scale(HADS), and nutritional status will be determined throughweight and the Subjective Global Assessment (SGA) toassess for malnutrition. Serious adverse events (SAE) aredefined as an adverse event that led to death and/or ledto serious deterioration in health of a patient, whereasadverse events (AE) are defined as any untoward orunfavorable medical occurrence in a patient. Complica-tions recorded include falls, pneumonia, pressure areas,cardiac problems, seizures, reduced Glasgow Coma Scale,stroke, transient ischemic attack, urinary tract infection, de-pression, constipation, malnutrition, delirium, and “other”including shoulder pain, deep venous thrombosis, and urin-ary retention [24, 25].Data collection time pointsAn investigator will conduct the initial assessment onentry to the study. Blinded assessors will perform dis-charge assessments immediately prior to discharge fromthe ASU or when a decision for palliative intent is made.Blinded assessors will also undertake follow-up phonecalls at 3 months post-stroke to determine mRS, livingarrangement, Health State Score [26], and if any SAEshave occurred after discharge. Three months after theEE block, another period of behavioral mapping willoccur to determine whether activity levels have beensustained in the ASU. We aim to recruit 30 participantsusing the same eligibility criteria and complete behav-ioral mapping on a single, randomly chosen day from7.30 am till 7.30 pm.Participant and staff experienceDuring both blocks, patient/carer and staff experienceswill be explored through surveys. A short patient andcarer survey will explore the patient/carer’s experienceand whether they felt sufficient stimulation was offeredto assist early rehabilitation and recovery during theacute stay. Staff surveys will be handed out to 25 nursingand therapy staff members of the unit. These surveyswill explore their perceptions of innovation, patient care,team relationships, work satisfaction, and workload duringeach block. In addition, after block 2, up to ten semi-structured interviews with nursing and therapy staff willbe conducted until saturation of data is reached. Theseinterviews will focus on staff experience during the EEintervention period only. Questions will aim to exploreperceived barriers in implementing an EE and what staffwill need to be able to sustain the EE in the future. The-matic content analysis will be performed on all qualitativedata. Figure 1 shows a flow chart of the pilot study.Sample sizeWe performed a sample size calculation to ensure that thispilot study has sufficient power to determine significantpositive effect on our primary outcome measure—totalactivity levels in stroke survivors. Estimates were based onRosbergen et al. Pilot and Feasibility Studies  (2016) 2:36 Page 4 of 6data from a recent study of the effect of an EE on activitylevels conducted during inpatient stroke rehabilitation [15].This study reported a mean increase in the proportion ofobservations with 'any activity' in the EE group of 13 %(SD 14) and the control (no EE) group of 2 % (SD 16.5),equivalent to an effect size of 0.719. We performed a one-sided, between-groups test as this past research has shownan enriched environment to increase activity levels instroke survivors [15]. Based on a rounded effect size of0.7, we calculated that we would need to recruit 26 partic-ipants per group to detect one standard deviation differ-ence between EE and non-EE groups for any activity withan alpha level of 0.05 and a power of 0.8. Allowing for aconservative dropout rate of 12 %, we will aim to recruit30 participants per group.Statistical analysisBaseline characteristics of participants will be describedusing means and standard deviations for continuous vari-ables and counts and percentages for categorical variables.To address the primary outcome (change in activity levelsfor 'any activity'), we will compare the proportion of activ-ity between usual care and EE intervention group. We willassume that at each observation, the participant remainsengaged in that activity for the entire 10-min interval; thiswill allow us to calculate the proportion of time eachgroup is engaged in any activity. Subsequently, we willexplore for differences in each activity domain and subcat-egories within domains. Consistent with previous researchin the field [15], unobserved and missing data will beexcluded from the analysis for the primary outcome ofchange in activity level. Total number of observations perparticipant will be summed and used to calculate theproportion of observations each participant is observed tobe engaged in any activity (and physical, social, and cogni-tive activity and other fields included in the data collectionsheet). The difference in activity levels between groups willbe determined using one-way ANCOVA with group asindependent variable, activity levels as the dependentvariable, and adjusting for covariates age (years), strokeseverity (NIHSS), and premorbid function (mRS). Todetermine differences in secondary outcome measures be-tween groups, one-way repeated-measures ANCOVA willbe performed for variables separately, adjusting for age(years), stroke severity (NIHSS), and premorbid function(mRS). We will adjust for the above covariates as thesecovariates impact on activity levels, functional outcomes,and mood in stroke survivors [27–29].DiscussionResearch has consistently shown that ASU care providesvery limited opportunities for people with a stroke to beinvolved in physical activities and that patients are oftenalone. Increased activity levels after stroke are associatedwith better functional outcomes and reduced complica-tion rates. In addition, with the aging population and therising incidence in stroke, there is a strong need for thedevelopment of resource-efficient interventions that canimprove patient and service outcomes without increas-ing staffing cost. The EE is an innovative interdisciplin-ary model of care that could build the capacity of acutestroke teams to deliver efficient and effective care forpeople with stroke.AcknowledgementsStudy status: recruitment for this study took place from June 2014 throughto July 2015.Authors’ contributionsAll authors have made an intellectual contribution to this research trial.Principal investigator IR and co-investigators SB, RG, and KH were responsiblefor designing the study protocol, ethic application, funding applications, andwriting and correcting the manuscript. SB and IR developed the statisticalanalysis plan. IR and KH adjusted the behavioral mapping documents andeducated the behavioral mapping staff. IR and associate investigators KW,AC, DR, JT, SR, and SM were responsible for the recruitment of participantsand data collection during the study. Associate investigator HJ wrote theoriginal behavioral mapping protocol. All authors have contributed to theconceptual design, development, and implementation of the intervention.All authors have read and approved the final version of the manuscript.Competing interestsThe authors declare that they have no competing interests.Assessment for eligibility and consentInitial assessmentDemographics, NIHSS, Oxford Classification, mRS, MSAS, 10-meter walk test, weight, MBI, speech screener and HADSDischarge assessmentmRS, MSAS, 10-meter walk test, weight, MBI, HADSpatient surveys3-months post stroke follow-up phone callmRS, Health State Score, living arrangement, SAEBlock 1: usual care group (N=30)Staff surveys at 6 weeks Block 2: EE intervention group (N=30) Staff surveys at 6 weeks Block 3: Sustainability   3-months post EE recruitment (N=30)Staff semi-structured InterviewsBehavioral Mapping AE and SAEBehavioral Mapping Fig. 1 Flowchart of study. NIHSS National Institutes of Health StrokeScale, mRS modified Rankin Scale, MSAS Mobility Scale for AcuteStroke, MBI Modified Barthel Index, HADS Hospital Anxiety andDepression Scale, EE enriched environment, AE adverse events,SAE serious adverse eventsRosbergen et al. Pilot and Feasibility Studies  (2016) 2:36 Page 5 of 6Ethics approval and consent to participateEthical approval has been obtained from Human Research Ethics Committee,Metro North Hospital and Health Service, The Prince Charles Hospital (HREC/14/QPCH/21), and from the Medical Research Ethics Committee, The Universityof Queensland (MREC/2014000371). Informed consent will be obtained fromparticipants or their substitute decision maker and from those participating insurveys and semi-structured interviews.Study organization and fundingThe trial is registered with the Australian New Zealand Clinical Trials RegistryANZCTN12614000679684. The study is supported by Wishlist Foundation,Sunshine Coast Hospital and Health Service (SCHHS) research grant, aQueensland Health Health Practitioner research grant, a SCHHS Scholarship,and by the Acute Stroke Unit and Allied Health Services, SCHHS.Author details1Division of Physiotherapy, School of Health and Rehabilitation Sciences,University of Queensland, Brisbane, Australia. 2Allied Health Services,Nambour General Hospital, Sunshine Coast Hospital and Health Service, POBox 547, Nambour 4560, Australia. 3Sunshine Coast Clinical School, TheUniversity of Queensland, Nambour, Australia. 4Department of PhysicalTherapy, University of British Columbia, Vancouver, BC, Canada. 5Nursing andMidwifery, Sunshine Coast Hospital and Health Service, Nambour, Australia.6Hunter Medical Research Institute, Newcastle, Australia.Received: 22 January 2016 Accepted: 20 July 2016References1. Stroke Unit Trialists’ Collaboration. Organised inpatient (stroke unit) care forstroke. 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Part II: predictors of depression after stroke andimpact of depression on stroke outcome: an updated systematic review ofobservational studies. Int J Stroke. 2014;9(8):1026–36.29. Veerbeek JM, Kwakkel G, van Wegen EE, Ket JC, Heymans MW. Earlyprediction of outcome of activities of daily living after stroke: a systematicreview. Stroke. 2011;42(5):1482–8.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services •  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submitSubmit your next manuscript to BioMed Central and we will help you at every step:Rosbergen et al. Pilot and Feasibility Studies  (2016) 2:36 Page 6 of 6


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