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      Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients

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          Abstract

          Background

          Most acute stroke patients with disabilities do not receive recommended rehabilitation following discharge to the community. Functional and social barriers are common reasons for non-adherence to post-discharge rehabilitation. Home rehabilitation is an alternative to centre-based rehabilitation but is costlier. Tele-rehabilitation is a possible solution, allowing for remote supervision of rehabilitation and eliminating access barriers. The objective of the Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial is to determine if a novel tele-rehabilitation intervention for the first three months after stroke admission improves functional recovery compared to usual care.

          Methods/design

          This is a single blind (evaluator blinded), parallel, two-arm randomised controlled trial study design involving 100 recent stroke patients. The inclusion criteria are age ≥40 years, having caregiver support and recent stroke defined as stroke diagnosis within 4 weeks. Consenting participants will be randomized with varying block size of 4 or 6 assuming a 1:1 treatment allocation with the participating centre as the stratification factor. The baseline assessment will be done within 4 weeks of stroke onset, followed by follow-up assessments at 3 and 6 months. The tele-rehabilitation intervention lasts for 3 months and includes exercise 5-days-a-week using an iPad-based system that allows recording of daily exercise with video and sensor data and weekly video-conferencing with tele-therapists after data review. Those allocated to the control group will receive usual care. The primary outcome measure is improvement in life task’s social activity participation at three months as measured by the disability component of the Jette Late Life Functional and Disability Instrument (LLFDI). Secondary outcome variables consist of gait speed (Timed 5-Meter Walk Test) and endurance (Two-Minute Walk test), performance of basic activities of daily living (Shah-modified Barthel Index), balance confidence (Activities-Specific Balance Confidence Scale), patient self-reported health-related quality-of-life [Euro-QOL (EQ-5D)], health service utilization (Singapore Stroke Study Health Service Utilization Form) and caregiver reported stress (Zarit Caregiver Burden Inventory).

          Discussion

          The goal of this trial is to provide evidence on the potential benefit and cost-effectiveness of this novel tele-rehabilitation programme which will guide health care decision-making and potentially improve performance of post-stroke community-based rehabilitation.

          Trial Registration

          This trial protocol was registered under ClinicalTrials.gov on 18 July 2013 as study title “The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study” (ID: The STARS Study, ClinicalTrials.gov Identifier: NCT01905917).

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          Most cited references17

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          EuroQol: the current state of play.

          R. Brooks (1996)
          The EuroQol Group first met in 1987 to test the feasibility of jointly developing a standardised non-disease-specific instrument for describing and valuing health-related quality of life. From the outset the Group has been multi-country, multi-centre, and multi-disciplinary. The EuroQol instrument is intended to complement other forms of quality of life measures, and it has been purposefully developed to generate a cardinal index of health, thus giving it considerable potential for use in economic evaluation. Considerable effort has been invested by the Group in the development and valuation aspects of health status measurement. Earlier work was reported upon in 1990; this paper is a second 'corporate' effort detailing subsequent developments. The concepts underlying the EuroQol framework are explored with particular reference to the generic nature of the instrument. The valuation task is reviewed and some evidence on the methodological requirements for measurement is presented. A number of special issues of considerable interest and concern to the Group are discussed: the modelling of data, the duration of health states and the problems surrounding the state 'dead'. An outline of some of the applications of the EuroQol instrument is presented and a brief commentary on the Group's ongoing programme of work concludes the paper.
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            Improving the sensitivity of the Barthel Index for stroke rehabilitation.

            The Barthel Index is considered to be the best of the ADL measurement scales. However, there are some scales that are more sensitive to small changes in functional independence than the Barthel Index. The sensitivity of the Barthel Index can be improved by expanding the number of categories used to record improvement in each ADL function. Suggested changes to the scoring of the Barthel Index, and guidelines for determining the level of independence are presented. These modifications and guidelines were applied in the assessment of 258 first stroke patients referred for inpatient comprehensive rehabilitation in Brisbane, Australia during 1984 calendar year. The modified scoring of the Barthel Index achieved greater sensitivity and improved reliability than the original version, without causing additional difficulty or affecting the implementation time. The internal consistency reliability coefficient for the modified scoring of the Barthel Index was 0.90, compared to 0.87 for the original scoring.
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              Outcome measures in acute stroke trials: a systematic review and some recommendations to improve practice.

              There is little consistency in the measurement of outcome in acute stroke trials, and this may complicate interpretation of the results and reduce the likelihood of detecting worthwhile drug effects. This study aims to investigate empirically the measures used to date and to give recommendations for future studies. A systematic review of all published randomized studies of acute stroke drug intervention was undertaken, and the measures used were recorded. Fifty-one studies involving 57 214 subjects were identified. These studies used 14 different measures of impairment, 11 different measures of activity, 1 measure of "quality of life," and 8 miscellaneous other measures. Timing of outcome assessments varied from 1 week to 1 year, with the modal time being 3 months. Many studies used ordinal measures but dichotomized results for analysis. Of the 51 studies included in the review, only 21 demonstrated benefit with the defined primary outcome measure. In several studies, however, post hoc analysis using varied outcome measures or varied cut points for dichotomizing outcomes resulted in positive results, whereas the primary study analysis failed to do so. There is no consensus on the level of outcome to be used, the method of measurement to be used, or the most appropriate timing of the assessment. It is recommended that future studies should include extended/instrumental activities and advanced mobility as components of the primary outcome measure, with outcome assessment being undertaken at 6 months. New initiatives in developing stroke-specific outcomes may address some of the current problems in the assessment of stroke outcomes
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                Author and article information

                Contributors
                +65-65164979 , Gerald_Koh@nuhs.edu.sg
                shihcheng@nus.edu.sg
                arthurtay@nus.edu.sg
                angela_cheong@nuhs.edu.sg
                ng.yee.sien@sgh.com.sg
                gnrdsd@sgh.com.sg
                Carolina_Png@amkh.org.sg
                kevin.caves@duke.edu
                karenkoh7@gmail.com
                yoga.nus@gmail.com
                phan@nus.edu.sg
                bee_choo_tai@nuhs.edu.sg
                cynthiachen@u.nus.edu
                effie_chew@nuhs.edu.sg
                medcz@nus.edu.sg
                A0102238@nus.edu.sg
                koh.yen.sin91@nus.edu.sg
                helen.hoenig@va.gov
                Journal
                BMC Neurol
                BMC Neurol
                BMC Neurology
                BioMed Central (London )
                1471-2377
                5 September 2015
                5 September 2015
                2015
                : 15
                : 161
                Affiliations
                [ ]Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, #10-03-G, Tahir Foundation Building, Block MD1, 12 Science Drive 2, Singapore, 117549 Singapore
                [ ]Yong Loo Lin School of Medicine, National University of Singapore, National University Health System, Singapore, Singapore
                [ ]Department of Electrical and Computer Engineering, National University of Singapore, Singapore, Singapore
                [ ]Singapore General Hospital, Singapore, Singapore
                [ ]National Neuroscience Institute, Singapore General Hospital campus, Singapore, Singapore
                [ ]Ang Mo Kio Thye Hua Kwan Hospital, Singapore, Singapore
                [ ]Department of Surgery, Medicine and Biomedical Engineering, Duke University, Durham, USA
                [ ]Department of Rehabilitation Medicine, National University Hospital, Singapore, Singapore
                [ ]Department of Biological Science, National University of Singapore, Singapore, Singapore
                [ ]Investigational Medicine Unit, National University Health System, Singapore, Singapore
                [ ]Physical Medicine & Rehabilitation Service, Durham Veterans Affairs Medical Centre, Durham, USA
                Article
                420
                10.1186/s12883-015-0420-3
                4560876
                26341358
                5fed9fb2-6783-4459-a672-f2c5141416aa
                © Koh et al. 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the 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.

                History
                : 5 March 2015
                : 1 September 2015
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2015

                Neurology
                tele-rehabilitation,home rehabilitation,stroke,post-stroke functional recovery
                Neurology
                tele-rehabilitation, home rehabilitation, stroke, post-stroke functional recovery

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