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1 Balance and walking after stroke rehabilitation: A randomised controlled trial comparing supported discharge in a day-unit or at home with treatment as usual Journal: Manuscript ID: bmjopen-0-00 Article Type: Research Date Submitted by the Author: -Oct-0 Complete List of Authors: Gjelsvik, Bente; Haukeland University Hospital, Department of Physiotherapy; University of Bergen, Department of Global Public Health and Primary Care, Physiotherapy Research Group Hofstad, Håkon; Haukeland University Hospital, Department of Physical Medicine and Rehabilitation; University of Bergen, Department of Global Public Health and Primary Care, Physiotherapy Research Group Smedal, Tori; Haukeland University Hospital, Department of Physiotherapy Eide, Geir; Haukeland University Hospital, Centre for Clinical Research Næss, Halvor; Haukeland University Hospital, Department of Neurology Skouen, Jan; Haukeland University Hospital, Department of Physical Medicine and Rehabilitation; University of Bergen, Department of Global Public Health and Primary Care, Physiotherapy Research Group Frisk, Bente; Haukeland University Hospital, Department of Physiotherapy Daltveit, Silje; Haukeland University Hospital, Department of Physiotherapy Strand, Liv; Haukeland University Hospital, Department of Physiotherapy; University of Bergen, Department of Global Public Health and Primary Care, Physiotherapy Research Group <b>primary Subject Heading</b>: Secondary Subject Heading: Neurology Keywords: Rehabilitation medicine Adult neurology < NEUROLOGY, Stroke < NEUROLOGY, REHABILITATION MEDICINE, Clinical trials < THERAPEUTICS - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

2 Page of Balance and walking after stroke rehabilitation: A randomised controlled trial comparing supported discharge in a day-unit or at home with treatment as usual Corresponding author:, Bente Elisabeth Bassøe Gjelsvik, MSc Contact information: bente.elisabeth.bassoe.gjelsvik@helse-bergen.no Centre for Clinical Research, Haukeland University Hospital, 0 Bergen, Norway Telephone: + Mobile: + 0 Telefax: + 0, Håkon Hofstad, MD Contact information: haakon.hofstad@helse-bergen.no Telephone: + Telefax: + 0 Tori Smedal, PhD Contact information: tori.smedal@helse-bergen.no Telephone: + Geir Egil Eide, Dr. philos Contact information: geir.egil.eide@helse-bergen.no Telephone: : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

3 Page of Halvor Næss, Professor, PhD Contact information: halvor.ness@helse-bergen.no Telephone: + 0, Jan Sture Skouen, Professor, PhD Contact information: jan.skouen@helse-bergen.no Telephone: + 00 Telefax: + 0 Bente Frisk, MSc Contact information: bente.frisk@hib.no Telephone: + Silje Daltveit, BSc Contact information: silje.daltveit@helse-bergen.no Telephone: + 00/, Liv Inger Strand, Professor, Dr. philos. Contact information: liv.strand@igs.uib.no Telephone: + Telefax: + 0 Department of Physiotherapy, Haukeland University Hospital, Bergen, Norway Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Bergen, Norway Department of Neurology, Haukeland University Hospital, Bergen, Norway Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

4 Page of Department of Global Public Health and Primary Care, Physiotherapy Research Group, University of Bergen, Norway Key-words: Stroke, balance, trunk control, walking, supported discharge Word count of text: Figures and tables Figures: (flow diagram) Tables: Web only: table - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

5 Page of Abstract Objective. To compare the effects of three rehabilitation models: two with supported discharge in two different environments and one treatment as usual, on balance and walking three months after stroke. Design. Randomised controlled study with blinded assessors. Computer-generated randomisation procedure. Setting. Hospital stroke unit and primary health care. Participants. patients with acute strokes. completed the study: / males/females, mean (SD). (.) years. Inclusion criteria: living at home prior to stroke, inclusion - days after onset and -0 hours after admission to the stroke unit, National Institutes of Health Stroke Scale of -, assessed with Postural Assessment Scale for Stroke (PASS) and discharged directly home from the stroke unit. Written informed consent was obtained. Exclusion criteria: serious psychological illness, drug addiction, serious co-morbidity like terminal cancer, and poor knowledge of the Norwegian language. Interventions. Supported discharge with treatment in ) day-unit or ) own home. Patients in the third group received treatment as usual after hospital discharge. Outcome measures. Primary: PASS. Secondary: Trunk Impairment Scale modified Norwegian version; timed Up-and-Go; meter timed walk; self-reports on problems with walking, balance, ADL, physical activity, pain and tiredness. The patients were tested before randomisation and months after inclusion. Results. There was no difference in change between the groups for PASS. There were differences in change for trunk control, median (%CI): day-unit, (0.,.); home-rehabilitation, (.0,.); control, (0.,.), p=0.0, and for - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

6 Page of self-report on walking, p=0.0, and ADL, p=0.0. Day-unit group improved above clinically important change for walking speed. Conclusions. Supported discharge was shown to be somewhat superior to treatment as usual. Home-rehabilitation seemed most effective for trunk control, day-unit rehabilitation for walking and perception of walking, and supported discharge irrespective of context more effective in improving perception of ADL as compared to treatment as usual. Article summary section Strengths of this study Use of both objective and self-reported outcome measures representing both body-functions and activity domains of the ICF Sample size giving strong power Limitations of this study High baseline scores for primary outcome Loss to follow-up Trial registration: The present study is a part study of the Early Supported Discharge after Stroke in Bergen, ClinicalTrials.gov (NCT00). Funding: This work was supported by the Research Council of Norway (grant number ), the Norwegian Fund for Post-graduate Training for Physiotherapists, Bergen Health Authority and the Regional Health Authority of Western Norway (no grant numbers). - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

7 Page of Allocation: Patients Follow-up: Patients Analysis: Patients Randomised Excluded (n=) Not tested with PASS (n = ) Discharged to other institution (n = ) Experimental group Allocated to intervention (n = ) Day-unit rehabilitation (n = ) Lost to follow-up (n = ) withdrew did not attend retest tester not available not available for retesting Analysed (n = ) patients received allocated intervention and were tested at both time points patient who did not receive allocated intervention but was tested at both time points were included the analyses Met inclusion criteria in the ESD Stroke Bergen Study (n = ) Excluded (n=) Not tested with PASS (n = ) Discharged to other institution (n = ) Baseline testing (n = 0) Experimental group Allocated to intervention (n = ) Home-rehabilitation (n = 0) Lost to follow-up (n = ) withdrew not testable did not attend retest not available for retesting Retested months after inclusion Analysed (n = ) patients received allocated intervention and were tested at both time points patients who did not receive allocated intervention but were tested at both time points were included in the analysis Excluded (n=) Not tested with PASS (n=) Discharged to other institution (n = ) Declined to participate (n = ) Control Allocated to control (n = ) Treatment as usual (n = ) Lost to follow-up (n = 0) withdrew did not attend retest tester not available not available for retesting Analysed (n = ) Figure. Flowchart of patients 00-0, randomised to treatment groups and tested both at baseline and months after inclusion. Abbreviation: ESD: Early Supported Discharge; PASS: Postural Assessment Scale for Stroke. - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

8 Page of INTRODUCTION Several studies have been published in the last decade to evaluate the effect of early supported discharge on both short and long term outcome after stroke. [-] The greatest benefits from such studies are associated with support from a coordinated multidisciplinary team.[] Early supported discharge combined with adequate resources has been found to reduce long-term physical dependency and need for admittance to an institution.[] However, rehabilitation models may differ, and the effectiveness of different models should be investigated. To our knowledge, effects of early supported discharge on the patients physical capacity, defined as what a person with a health condition can do in a standard environment,[] have only been examined in studies, showing no differences in balance and walking between the groups.[-] Two of these studies were poorly powered[,] and all had small sample sizes. Thus, the knowledge of changes in physical capacity and comparisons between treatment arms do not seem sufficiently explored. It is therefore desirable to examine change in physical capacity in larger scale studies comparing the effect of different rehabilitation models. The main objective of the study was to compare the effects on balance and walking months after stroke of rehabilitation models: two experimental conditions with supported discharge and treatment either at home or in a day-unit, and one control with treatment as usual. The social and physical context for rehabilitation is seen important to patient outcome.[] Rehabilitation provided at home allows the patient to practise in a real-life environment, which could enhance functioning and participation, and an easier and more direct transfer of skills learned in therapy. Meeting the actual needs of the patient and family within their own homes could motivate the patient more than when training takes place in an outpatient context. At the same time, - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

9 Page of rehabilitation in a centre could give enhanced training effects,[] which could improve balance and walking to a greater degree. The research hypothesis was: Supported discharge by a designated multidisciplinary team with rehabilitation either at home or in a day-unit after stroke, is superior to treatment as usual in improving balance and walking, as explored by physical capacity tests and self-report measures. METHOD Design overview A single blinded randomised controlled study was conducted in the context of a larger RCT trial, the Early Supported Discharge after Stroke in Bergen (ESD Stroke Bergen), registered in ClinicalTrials.gov (NCT00). The ESD Stroke Bergen had a predetermined inclusion period of years, and the protocol has already been published.[] The study was approved by the Regional Committee for Medical and Health Research Ethics and the Norwegian Social Science Data Services. Participants and allocation The study was conducted at a university hospital in collaboration with the primary health care services. The patients were recruited from the hospital stroke unit from December 00 to December 0, with a months follow-up until March 0. A stroke unit physician assessed eligibility for inclusion, and suitable patients were given a folder containing written information about the study. Inclusion criteria: the patients had to live in Bergen and at home prior to the stroke, be included in the study - days after stroke onset and between -0 hours after admission to the stroke unit, be awake and have a National Institutes of Health Stroke Scale score - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

10 Page of (NIHSS)[-] of -. The patients had to give written informed consent. If this was not possible, consent was given by next of kin, and the patients had to confirm this in writing as soon as they were able to. For the present study, only patients who were discharged directly home from the stroke unit and assessed by the primary outcome measure Postural Assessment Scale for Stroke (PASS)[] were included. Exclusion criteria were serious psychological illness, drug addiction, serious co-morbidity like terminal cancer, or having too poor knowledge of the Norwegian language to understand information. After inclusion and before randomisation, baseline testing was performed. For allocation of the patients, a computer-generated list of random numbers in blocks of ( patients allocated to each group) generated by an independent researcher at the local university, was used. A nurse at the stroke unit was responsible for giving the allocated patients written information about their assigned groups. The patients were tested at baseline and months after inclusion. Four experienced neurorehabilitation physiotherapists conducted the physical capacity tests and collected related self-reports. To assure standardisation, the physiotherapists underwent a period of training together in using the physical tests prior to the study. Neurologists were responsible for assessing NIHSS, and trained stroke nurses assessed Barthel Index (BI)[,] and modified Rankin Scale (mrs)[,] at baseline. At months BI and mrs were administered by a trained physiotherapist. All outcome assessors were blinded to the group of the patient. The patients were retested at the hospital out-patient clinic month after inclusion, according to study protocol. - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

11 Page of Interventions For the experimental groups two designated coordinated multidisciplinary teams were established: one ambulatory and one community health care team, each consisting of a nurse, a physiotherapist and an occupational therapist. The ambulatory team was a hospital based out-reach team which organised the transition from hospital to the patient s home. The health care team was based in the community and was responsible for the rehabilitation and actual treatment. The nurse was team leader and coordinator. The teams communicated and cooperated closely. The patients were discharged from hospital to own homes as early as possible. Experimental group I, day-unit rehabilitation: The patients travelled to a local dayrehabilitation unit in the community to receive treatment from the health care team. Treatment was mainly physiotherapy and occupational therapy and orientated towards impairments in body functions as well as task-oriented training. Experimental group II, home-rehabilitation: The patients received treatment from the health care team in their own homes. Treatment was mainly physiotherapy and occupational therapy and orientated towards task-oriented training in daily activities. The main difference between the experimental groups was the context in which the patients received their rehabilitation interventions. Control group, treatment as usual: The patients followed a routine discharge procedure with outpatient therapy on an ad hoc basis. Treatment by different health care professionals depended on the patients perceived needs, and consisted mostly of physiotherapy either at home or in private physiotherapy practices. Other health professions could be involved (occupational therapy and home nursing), however, the interventions were not team oriented or coordinated. - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

12 Page of Patients in all groups received speech therapy on an outpatient basis if needed. Outcomes and follow-up All patients were evaluated with a wide range of medical, ADL, physical capacity and self-report measures at baseline and at months. Brain scans using computer tomography or magnetic resonance imaging were performed shortly after admission to the stroke unit. Primary outcome measure Postural Assessment Scale for Stroke (PASS) was used to assess (a) ability to maintain a position, and (b) ability to maintain equilibrium during positional changes.[,] PASS contains items (0, highest score best), and has shown high sensitivity to change in postural control during the first - months post stroke.[,,0] A change of points for an individual reflects true change.[] PASS has demonstrated high internal consistency, good psychometric properties and predictive ability for ADL-function one year post stroke.[] Secondary outcome measures Trunk Impairment Scale-modified Norwegian version (TIS-modNV) was used to evaluate the patient s level of trunk control post stroke.[] The scale consists of ordinal items and has demonstrated good construct validity, excellent internal consistency, and high inter-tester and test retest reliability for the total score (0, highest score best). A change of points in an individual reflects true change. Functional Ambulation Categories (FAC)[] categorises the patient s walking ability in levels (0, highest category best). A m indoor walking distance is needed, as well as stairs to discern between categories and. The test has demonstrated - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

13 Page of good reliability, validity, and sensitivity to change during the first months post stroke. Timed Up-and-Go (TUG)[,] is a test of balance, walking speed and ADL. The patient rises from a chair, walks m, turns, walks back to the chair and sits down. Time used for the whole sequence is measured. TUG is sensitive for change over time, has shown predictive ability for walking outside unaided,[] and has demonstrated acceptable reliability and validity in stroke.[] Time used was transformed to m/s before analysis. m timed walk (mtw)[,] is a test for walking speed. mtw at a comfortable speed is seen to be the most responsive walking test during the first weeks post stroke, and has been reported to correlate with functional ability and balance confidence.[] A recommended - m acceleration and deceleration phase was used, and time used was transformed to m/s. This test was not included until the end of February 00, and the first patients were not tested. Patients who were unable to walk were given a score of 0 m/s in the walking tests. Self-report measures Numerical Rating Scales[] were used to uncover the patient s own perception of stroke-related problems with walking, balance, ADL, safety in physical activity, pain and tiredness. Other NIHSS is used to assess, amongst others, motor and sensory function, speech and language. NIHSS has shown high reliability and validity.[,] The scale used in this study was a items Norwegian version (0-, lowest score best), where mild stroke =0-, moderate =-, and severe.[] - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

14 Page of BI is a items scale (0-0, highest score best) used to assess the patient s dependence in ADL function, and has been reported to be a reliable and valid measure.[,] Dependence in ADL is defined as <.[0,] Modified Rankin Scale (mrs) is a level scale (0, lowest score best) used to measure outcome related to dependency and death, defined as equivalent to mrs >.[] Sample size calculation To detect a mean difference in change in PASS of points (above measurement error) from baseline to months between the groups assuming a standard deviation of. points[] for the change scores at significance level % (alpha=0.0), at least 0 patients in each group would give a power of at least 0% (analysis of variance F-test). (This assumes that the mean changes are equally spaced between the groups; with a more extreme distribution the power increases). The statistical program SamplePower was used to determine the power of the study. The ESD Stroke Bergen Study used a different main outcome measure than the present study, and the predetermined inclusion period of years was therefore expected to yield a larger amount of data than was needed for our study alone. Statistics Descriptive statistics were used for the background variables, baseline and change scores of the physical capacity tests and self-report measures. To compare baseline data of patients who were tested with PASS at both baseline and at months with those who were not tested with PASS at months, the independent t-test or Mann- Whitney s U-tests was used for continuous variables depending on the distribution, and the chi-square for categorical variables. - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

15 Page of One-way analysis of variance (ANOVA) was used to compare baseline scores between the groups. When data were not normally distributed or categorical, the corresponding non-parametric statistical tests were used (Kruskal-Wallis, chi-square), respectively. Non-parametric statistical test (Kruskal-Wallis) was used to compare difference in change between the groups as the change scores were not normally distributed. If a statistical significant difference (<0.0) between groups was found in the analysis, pairwise tests for independent groups were performed (Mann-Whitney U-test) using significance level 0.0/=0.0 to adjust for multiple comparisons. Simple (unadjusted), multiple (fully adjusted) and backward stepwise multiple linear regression analyses were performed for each of PASS, TIS-modNV, mtw and TUG scores at months as dependent variables on group allocation including age, gender, co-habitation, diagnosis, diabetes, previous stroke, previous nursing care, thrombolysis, baseline NIHSS scores and baseline scores of the dependent variable. The statistical programmes package SPSS (SPSS Inc. Chicago, Illinois 00) was used for all data analysis. RESULTS The predetermined inclusion period for the ESD Stroke Bergen Study resulted in 0 patients who were willing to participate. They were randomised into groups (Figure ). Excluded from the study were patients who were not tested with PASS at baseline and patients who were discharged from the stroke unit to a hospital rehabilitation unit or another institution. Of the remaining patients were in the day-unit group, 0 in the home-rehabilitation group and in the control group. In the day-unit group, (.%) were lost to follow-up; home-rehabilitation group, - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

16 Page of (.%); control group, 0 (.%), a total of (.%). Three patients in total, in the day-unit and in the home-rehabilitation groups, did not receive the allocated intervention, but were tested at both time points and were included in intention-totreat analyses. Insert Figure (Flowchart) about here Baseline characteristics are shown in Table. More men than women were tested with PASS at baseline, and most patients suffered ischemic strokes. Compared to patients who were tested at both baseline and months, the patients who were not tested at both test points were older, fewer lived with a partner, and they had more previous strokes and previous nursing care. - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

17 Page of Table. Baseline characteristics of all patients (N = ) discharged home after stroke unit stay. All Tested and retested Not retested with p-value Statistic Variables N = with PASS n = PASS n = Age; mean (SD), min, max 0. (.),. (.),.0 (.), <0.00 t-test Gender; n (%) 0. χ -test Male (.) (0.0) (.) Female (.) (0.0) 0 (.) Living with partner; n (%) (.) (.) (.) <0.00 χ -test Stroke diagnosis; n (%) 0.00 χ -test Ischemic (.0) (.) (.) Haemorrhagic (.0) (.) (.) Localization of lesion; n (%) 0. χ -test Right hemisphere 0 (.) (.) (.) Left hemisphere (.) (.) (0.) Bilateral (.) (.) (.) Brainstem (.) (.) (.) Cerebellum (.0) (.) (.) Most affected body half; n (%) 0. χ -test Right (.) 0 (.) (.) Left 0 (.) (.0) (.) Bilateral (. (.) (.) Thrombolysis; n (%) 0 (.0) (.) (.).000 χ -test Diabetes; n (%) a (.) (.) (.) 0. χ -test Previous stroke; n (%) b (.) (.) 0 (.) 0.0 χ -test Previous nursing care; n (%) (.) (.) (.) 0.0 χ -test Days stroke unit; mean (SD), min, max. (.),. (.0),. (.), 0. t-test a b Missing information on patient; Missing information on patients. Significant values (p<0.0) marked in bold; the p-values refer to the comparison between the two groups. on December 0 by guest. Protected by copyright. - : first published as./bmjopen-0-00 on May 0. Downloaded from

18 Page of There were significant differences in baseline PASS, BI, TUG and mtw, with patients not tested at both test points scoring worse than those who were retested (Table ). - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

19 Page of Table. Comparison of physical function at baseline between patients tested with PASS at both time points and patients who were not retested with PASS at three months, N = Variables Tested and retested with PASS n = Not retested with PASS n = p-value Statistic n median (IQR) min, max n median (IQR) min, max PASS (), 0 (), <0.00 M - W FAC (), () 0, 0. χ -test FAC; n (%) 0 0 (-) (.) (.) (.) (.) (.) (.) (.) (.) (.0) (.) (0.) NIHSS () 0, () 0, 0. M W BI a 0 (0), 0 0 (), M - W mrs () 0, () 0, 0. χ -test mrs; n (%) 0 (.) (.) (.) (.) (.) (.) (.) (.) (.) (.) n mean (SD) min, max n mean (SD) min, max TIS-modNV. (.),. (.0), 0. t-test TUG m/s 0. (0.) 0.00,. 0. (0.) 0.00,.00 <0.00 t-test mtw m/s d 0. (0.) 0.00,. 0. (0.0) 0.00, t-test Abbreviations: PASS: Postural Assessment Scale for Stroke, main outcome; TIS-modNV: Trunk Impairment Scale modified Norwegian version; FAC: Functional Ambulation Categories; TUG: timed Up-and-Go; mtw: meter Timed Walk; NIHSS: National Institutes of Health Stroke Scale; BI: Barthel Index; mrs: modified Rankin Scale; M W: Mann-Whitney U-test; t-test: t-test for independent samples. Significant values marked in bold. a Missing information on one patient; b patients were not tested at baseline. on December 0 by guest. Protected by copyright. - : first published as./bmjopen-0-00 on May 0. Downloaded from

20 Page of Because of the substantial number of patients excluded or lost to follow-up after randomisation to the original trial ESD Stroke Bergen, we compared baseline characteristics and test scores of the patients that were included in the present study. There were no differences between the experimental and control groups for any background characteristics (Web only file) or any physical outcome measure (Table ). The median score for PASS was high, and the mean (SD) walking speed (mtw) was above community walking speed, estimated as 0. m/s,[,] for all groups. The mean (SD) stay in the stroke unit was. (.) days with no significant difference between the groups, p= : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

21 Page 0 of Table. Baseline scores of the physical and self-report measures, and comparison between experimental and control groups (N = ). Experimental group I Experimental group II Control p- Statistic Variables n = n = 0 n = value median (IQR) min, max median (IQR) min, max median (IQR) min, max PASS (), (), () 0, 0. K - W FAC () 0, (), (), 0. χ -test FAC; n(%) 0 (.) 0 (-) 0 (-) 0 (-) (.) (.) (.) (.) (.) (.) (.) (0.0) (.) (.) (.) (.) (0.0) (.) NIHSS (), () 0, () 0, 0. K - W BI a 0 (0), 0 0 () 0, 0 0 () 0, K - W mrs 0. χ -test mrs; n (%) 0 (.) (.) (.) (.0) (.) (0.0) (.) (.) (.) (.) (.0) (.) (.) (.) (.) mean (SD) min, max mean (SD) min, max mean (SD) min, max TIS-modNV. (.),. (.),. (.), 0. ANOVA TUG m/s 0. (0.0) 0.00,. 0. (0.) 0.00,. 0. (0.) 0.00,. 0. ANOVA mtw m/s 0. (0.) 0.00,. 0. (0.) 0,00,. 0. (0.) 0.00,. 0.0 ANOVA NRS b. Walking. (.) 0,. (.) 0,.0 (.) 0, 0. ANOVA. Balance. (.) 0,. (.) 0,. (.) 0, 0. ANOVA. ADL. (.) 0,. (.) 0,. (.) 0, 0.0 ANOVA.Physical activity. (.0) 0,.0 (.) 0,. (.) 0, 0.0 ANOVA. Pain. (.) 0,. (.) 0,. (.) 0, 0. ANOVA. Tiredness. (.) 0,. (.) 0,. (.) 0, 0. ANOVA Experimental group I: day-unit rehabilitation; Experimental group II: home-rehabilitation. Abbreviations: PASS: Postural Assessment Scale for Stroke; TIS-modNV: Trunk Impairment Scale modified Norwegian version; FAC: Functional Ambulation Categories; TUG: timed Up-and-Go; mtw: meter Timed Walk; BI: Barthel Index; NIHSS: National Institutes of Health Stroke Scale; mrs: modified Rankin Scale; NRS: Numerical Rating Scale; IQR: Interquartale range; SD: standard deviation; K W: Kruskal-Wallis test; ANOVA: analysis of variance (one-way). a Missing BI: control; b Missing NRS, NRS, NRS, NRS, NRS : in Experimental group I, in Experimental group II, in Control; Missing NRS : in Experimental group I, in Experimental group II, in Control. on December 0 by guest. Protected by copyright. - : first published as./bmjopen-0-00 on May 0. Downloaded from 0

22 Page of The intervention by the health care team varied between and hours each time, - times per week, mainly given by a physiotherapist or occupational therapist, plus two days self-exercises at home per week mainly related to activities and participation, for up to five weeks, individually adjusted in time and content to the patients needs.[] The mean (SD) time between test and retest was. (.) weeks, with no difference between the groups. There was no difference in lost to follow-up between the groups, p=0.0. A significant difference in change between the groups was shown for TISmodNV and for self-reports on walking and ADL (Table ). Patients in the homerehabilitation group improved more in trunk control than day-unit and control, however, pairwise analyses adjusted for multiple comparisons were non-significant. Self-report on walking demonstrated greatest improvement in the day-unit group, with pair-wise analyses showing a significantly greater improvement for day-unit as compared to control, p=0.00. Self-report on ADL demonstrated that both experimental groups improved more than control, with a significant difference between home-rehabilitation and control, p=0.00. No other pair-wise comparisons demonstrated significant differences in change. - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

23 Page of Table. Between-group comparisons of change scores in the physical and self-report measures (N = ). Variables Experimental group I n = Experimental group II n = Control n = p- median (IQR) % CI median (IQR) % CI median (IQR) % CI value a PASS 0 () -0.,. () 0.,. () 0.,. 0. TIS-mod-NV () 0.,. ().0,. () 0.,. 0.0 FAC 0 () 0.,.0 () 0.,. 0 () 0.0, BI 0 (0) -.,. 0 () -0.,. 0 (0) -.,. 0. NIHSS b - () -., () -.0, -. - () -.0, mrs b 0 () -0., 0. - () -0., () -0., NRS b Walking - () -., () -., () -., Balance - () -., () -., () -., ADL - () -., () -., -. 0 () -., Physical activity - () -., () -., () -., Pain 0 () -., 0. 0 (0) -., 0. 0 () -0., Tiredness 0 () -., 0. 0 () -0.0, 0. 0 () -0., mean (SD) % CI mean (SD) % CI mean (SD) % CI TUG 0. (0.) 0.0, (0.) 0.0, (0.) -0.0, mtw 0. (0.) 0., (0.) 0.0, (0.) 0.0, Experimental group I: day-unit rehabilitation; Experimental group II: home-rehabilitation. Abbreviations: PASS: Postural Assessment Scale for Stroke, main outcome; TISmodNV: Trunk Impairment Scale-modified Norwegian version; FAC: Functional Ambulation Categories; TUG: timed Up-and-Go; mtw: meter Timed Walk; BI: Barthel Index; NIHSS: National Institutes of Health Stroke Scale; mrs: modified Rankin Scale; NRS: Numerical Rating Scale; ADL: activities of daily living; IQR: Interquartile range; SD: standard deviation; CI: confidence interval; a Non-parametric analysis: Kruskal-Wallis test; b Negative values indicate improvement in condition. Significant values marked in bold. on December 0 by guest. Protected by copyright. - : first published as./bmjopen-0-00 on May 0. Downloaded from

24 Page of Multiple regression analyses for PASS at months demonstrated a significant effect of age, baseline scores, previous cerebral lesion and previous nursing care with an explained variance of.% (Table ). - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

25 Page of Table. Multiple regression of PASS at months, N = Unadjusted simple regression models Adjusted multiple linear regression model Final multiple linear regression model a Predictors b %CI P- value R b %CI P- value b %CI P- value Age , -0. < , ,, Gender , ,. 0. Female 0 reference 0 reference Habital status , ,. 0. Living with partner 0 reference 0 reference PASS baseline 0. 0., 0. < , 0. < , 0. <0.00 Diagnosis , ,.0 0. Infarction 0 reference 0 reference Thrombolysis , ,.0 0. Yes 0 reference 0 reference Diabetes. 0.0, ,. 0. Yes 0 reference 0 reference Prev. cerebral lesion. 0., , , Yes 0 reference 0 reference Prev. nursing care..,.0 < , ,. 0.0 Yes 0 reference 0 reference Rehabilitation group Experimental I , , 0. Experimental II , , 0. Control 0 reference 0 reference R R adj Experimental group I: day-unit rehabilitation; Experimental group II: home-rehabilitation. a From backward stepwise selection at significance level 0.0. Abbreviations: PASS: Postural Assessment Scale for Stroke; Prev.: Previous; R adj: adjusted R. on December 0 by guest. Protected by copyright. - : first published as./bmjopen-0-00 on May 0. Downloaded from

26 Page of Multiple regression analyses for TIS-modNV at months found a significant effect of TIS-modNV baseline scores, previous stroke and previous nursing care giving an explained variance of.% (adjusted); for mtw at months age, baseline walking speed, previous stroke and nursing care as well as thrombolytic treatment gave an explained variance of.% (adjusted); and for TUG at months baseline TUG speed, previous stroke and nursing care as well as thrombolytic treatment gave an explained variance of.% (adjusted). Group allocation did not explain any of the variance in any of the dependent variables examined. DISCUSSION We found significant differences in change between the groups for trunk control and self-report on walking and ADL. Pairwise comparisons demonstrated a larger improvement in self-reported walking in the day-unit group as compared to control, and a larger improvement in self-reported ADL after home-rehabilitation as compared to control. Previous stroke and nursing care as well as baseline scores of the dependent variable were shown as explanatory factors of all balance and walking measures at months. Age was found significant for outcome of PASS and walking speed, and thrombolytic treatment for both walking tests. Strengths of this study are the use of both objective and self-reported outcome measures by blinded assessors for comparing balance and walking between study groups, and that both body-function and activity domains of the ICF are captured. The present study was designed towards early supported discharge for the day-unit and home-rehabilitation groups, but unexpectedly patients in the control group was discharged from the stroke unit just as early as the experimental groups. The acute management of stroke in stroke units has changed over the last decade and is - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

27 Page of constantly developing, especially for patients with ischemic strokes,[] and as a consequence, patients are discharged earlier than before. Patients with mild to moderate disability seem to be most suitable for early supported discharge.[,,] Our patients fitted well into this category, and as such, the results should be representative for rehabilitation models aiming for early supported discharge. However, the results of this study cannot be extended to stroke patients with poorer baseline physical function. The patients of the original study (ESD Stroke Bergen) were randomised to three groups, making them comparable as to background variables and test scores. As a large portion of the patients were excluded or lost to follow-up we could not be sure that the patients who remained in the groups for the present study were still comparable. Analysis of our study patients demonstrated however, no statistical significant difference between the groups, neither in demographic nor in test variables at baseline. A subgroup analysis of patients being discharged to a secondary institution before going home to receive their experimental intervention awaits analyses. Loss to follow-up tended to be greatest in the day-unit group (non-significant). The day-unit patients travelled to the day-unit several times per week to receive their rehabilitation. As all patients had to travel to the out-patient clinic at the hospital for retesting, the day-unit patients may have been less motivated for an extra trip (to hospital) for retesting, which may explain some of the loss to follow-up for this group. The home-rehabilitation patients may have been motivated by training in a real-life situation where the family could be involved in the rehabilitation process, which may have reduced loss to follow-up in this group. Also, patients in the home-rehabilitation group might have experienced travelling to the out-patient clinic as a positive diversion. Patients who were lost to follow-up were older, more lived alone and they had a poorer baseline function, therefore attending - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

28 Page of retesting might have been too challenging. Real differences might therefore go undetected. A recommendation for future studies would be to undertake retesting in the patients homes if possible, to minimise loss to follow-up. A shortcoming of this study is also that we did not register to what extent the patients in the control group had received treatment. When comparing outcome of the groups, this would have been advantageous to know. We did not find any significant differences in change between the groups for the primary outcome measure PASS. All groups had an overall median high level of function at baseline, a BI of more than 0/0 being defined as mild disability.[] Spontaneous recovery[,] combined with generally high baseline scores implying a ceiling effect might explain this result. However, no difference were found in previous studies between experimental and control groups on early supported discharge where physical capacity tests were used as main outcome.[-] The outcome measures used in these studies were different from ours, even walking was tested differently in Widen-Holmquist et al.,[] Askim et al.[,] and in our study, and therefore no direct comparison between these studies is possible. We did find a difference between the groups for trunk control. Previous stroke and nursing care as well as baseline scores on trunk control explained.% of the variance in TIS-modNV at months, but these variables would not seem to explain this difference in change between the groups. Trunk control improved above measurement error in the home-rehabilitation group (median value > points). Selfreport on ADL improved more in the experimental groups, with pairwise comparisons demonstrating a significantly greater change only for home-rehabilitation as compared to control. A relationship between trunk control and functional ability in daily life in patients suffering from stroke has been indicated in several studies.[ : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

29 Page of ] Previous studies on ESD compared to ordinary service have not found differences between groups in ADL function,[,] but the patients perception of problems with ADL was not reported and the results are therefore not directly comparable to ours. We would have expected that patients who received treatment mainly aimed at improving tasks in their own homes would improve more than dayunit and control, as these skills would be practised with the health care team within their own environment. The patients in the day-unit group also practised ADL tasks to some degree, which may have enhanced their perception of improvement. The groups demonstrated a mean moderate trunk control at baseline, and for patients with this level of trunk control, home-rehabilitation would therefore seem to be most effective. Self-report on walking improved most in the day-unit group, with a significant difference demonstrated between day-unit and control. Also, walking speed improved above clinically important change, estimated as 0. m/s[] in the day-unit, but not in the home-rehabilitation and control groups (Table ). Interestingly, a recent study found a significant relationship between self-reported walking ability and gait performance in chronic stroke patients,[] which supports our finding. Travelling to a day-unit several times per week may have given the patients enhanced training effects[] as well as more experience with varied environments. For walking speed, day-unit rehabilitation would therefore seem most effective. More research is needed to investigate which context for rehabilitation is most effective for different aspects of physical function, also in patients with poorer baseline function after stroke. - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

30 Page of CONCLUSION The results of this study indicate that supported discharge for patients with mild disability after stroke is somewhat superior to treatment as usual. Home-rehabilitation may be more effective in improving trunk control and perception of problems with ADL and day-unit rehabilitation more effective in improving walking and the perception of walking as compared to treatment as usual. Acknowledgements The authors wish to thank all patients who willingly gave their informed consent to take part, and the physiotherapists who gave significant contributions towards making the study possible: Torunn Grenstad and Veronica Bøe who tested the patients at both time-points, Odd-Arne Bergset and Elisabeth Skjefrås Kvile who tested the patients at baseline, and Silje Mæhle who organised the logistics at months followup. Competing interest None declared. Funding statement This work was supported by the Research Council of Norway, grant number, the Norwegian Fund for Post-graduate Training (no grant number), Bergen Health Authority and the Regional Health Authority of Western Norway (no grant number). Authors contribution Bente Gjelsvik was the main author of the present study. She was involved from the start of the ESD Stroke Bergen Study in relation to the physiotherapist s role in exploring physical function. Data from the physical capacity tests were used in the - : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

31 Page 0 of present study. BG also trained the testers, assembled the database, did the background literature searches, performed the statistical analysis and wrote the present article. Håkon Hofstad was the research coordinator and collected data for the ESD Stroke Bergen Study, and has been involved discussions and the writing process of the present study. Tori Smedal has been involved in all aspects of the study: planning, discussion of analyses and results and frequent feedback during the writing process. Geir Egil Eide is biostatistician and has been involved in power calculations, advice on and help in statistical analysis and discussion of the results as well as the writing process. Halvor Næss has been involved in the planning of the study and recruitment of patients. He supplied some of the background information on the patients, and has been involved in discussions and in the writing process. Jan Sture Skouen was project leader for the ESD Stroke Bergen Study and has been involved in discussions and the writing process for the present study. Bente Frisk was involved from the start of the planning of the physiotherapists role in the ESD Stroke Bergen Study. She has been involved in discussions and the writing process. Silje Daltveit collected and plotted the data from the balance and walking measures, and has been involved in discussions and the writing process. Liv Inger Strand has been involved in all aspects of the present study: planning, discussion of analyses and results and frequent feedback during the writing process : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

32 Page of Reference List. Early Supported Discharge Trialists. Services for reducing duration of hospital care for acute stroke patients. Cochrane Database Syst Rev 00.. Langhorne P, Taylor G, Murray G, et al. Early supported discharge services for stroke patients: a meta-analysis of individual patients' data. Lancet 00;:0-.. Langhorne P, Holmqvist LW. Early supported discharge after stroke. J Rehabil Med 00;:-.. Fearon P, Langhorne P. Services for reducing duration of hospital care for acute stroke patients. Cochrane Database Syst Rev 0;:CD000.. World Health Organization. The model of ICF. In: World Health Organization, editor. Towards a Common Language for Functioning, Disability and Health.Geneva, WHO (accessed Oct 0). Widen-Holmquist L, von Koch L, Kostulas V, et al. A randomized controlled trial of rehabilitation at home after stroke in southwest Stockholm. Stroke ;:-.. Askim T, Morkved S, Indredavik B. Does an extended stroke unit service with early supported discharge have any effect on balance or walking speed? J Rehabil Med 00;: : first published as./bmjopen-0-00 on May 0. Downloaded from on December 0 by guest. Protected by copyright.

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