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      Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial

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          Abstract

          Background

          Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial.

          Methods

          A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities ( n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life.

          Discussion

          The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses.

          Trial registration

          Clinical Trials NCT01740635.

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          Most cited references46

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          A multifactorial intervention to reduce the risk of falling among elderly people living in the community.

          Since falling is associated with serious morbidity among elderly people, we investigated whether the risk of falling could be reduced by modifying known risk factors. We studied 301 men and women living in the community who were at least 70 years of age and who had at least one of the following risk factors for falling: postural hypotension; use of sedatives; use of at least four prescription medications; and impairment in arm or leg strength or range of motion, balance, ability to move safely from bed to chair or to the bathtub or toilet (transfer skills), or gait. These subjects were given either a combination of adjustment in their medications, behavioral instructions, and exercise programs aimed at modifying their risk factors (intervention group, 153 subjects) or usual health care plus social visits (control group, 148 subjects). During one year of follow-up, 35 percent of the intervention group fell, as compared with 47 percent of the control group (P = 0.04). The adjusted incidence-rate ratio for falling in the intervention group as compared with the control group was 0.69 (95 percent confidence interval, 0.52 to 0.90). Among the subjects who had a particular risk factor at base line, a smaller percentage of those in the intervention group than of those in the control group still had the risk factor at the time of reassessment, as follows: at least four prescription medications, 63 percent versus 86 percent, P = 0.009; balance impairment, 21 percent versus 46 percent, P = 0.001; impairment in toilet-transfer skills, 49 percent versus 65 percent, P = 0.05; and gait impairment, 45 percent versus 62 percent, P = 0.07. The multiple-risk-factor intervention strategy resulted in a significant reduction in the risk of falling among elderly persons in the community. In addition, the proportion of persons who had the targeted risk factors for falling was reduced in the intervention group, as compared with the control group. Thus, risk-factor modification may partially explain the reduction in the risk of falling.
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            A simple sample size formula for analysis of covariance in randomized clinical trials.

            Randomized clinical trials that compare two treatments on a continuous outcome can be analyzed using analysis of covariance (ANCOVA) or a t-test approach. We present a method for the sample size calculation when ANCOVA is used. We derived an approximate sample size formula. Simulations were used to verify the accuracy of the formula and to improve the approximation for small trials. The sample size calculations are illustrated in a clinical trial in rheumatoid arthritis. If the correlation between the outcome measured at baseline and at follow-up is rho, ANCOVA comparing groups of (1-rho(2))n subjects has the same power as t-test comparing groups of n subjects. When on the same data, ANCOVA is used instead of t-test, the precision of the treatment estimate is increased, and the length of the confidence interval is reduced by a factor 1-rho(2). ANCOVA may considerably reduce the number of patients required for a trial.
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              Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research.

              The minimal clinically important difference (MCID) for an instrument is a much sought after, but elusive figure. In this review we will highlight new findings in this area, including taxonomy of MCID, methods used to ascertain MCID, the perspective taken for evaluating importance, and other sources of variation for MCID values. In the end we believe the MCID will be a context-specific value rather than a fixed number. The review highlights the need to do methodological research in this area, especially concurrent comparisons between approaches, or across different patient groups. There are many faces to the MCID, it is not a simple concept, nor simple to calculate.
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                Author and article information

                Contributors
                Journal
                Trials
                Trials
                Trials
                BioMed Central
                1745-6215
                2013
                24 October 2013
                : 14
                : 350
                Affiliations
                [1 ]Department of Occupational Science and Occupational Therapy, University of British Columbia, Vancouver, Canada
                [2 ]Department of Physical Therapy, University of British Columbia, Vancouver, Canada
                [3 ]Department of Computer Science, University of British Columbia, Vancouver, Canada
                [4 ]Faculty of Nursing, University of Manitoba, Winnipeg, Canada
                [5 ]Faculty of Health Sciences, Simon Fraser University, Burnaby, Canada
                Article
                1745-6215-14-350
                10.1186/1745-6215-14-350
                3874600
                24156396
                e0992413-f54e-479d-b369-cf7ea4666802
                Copyright © 2013 Giesbrecht et al.; licensee BioMed Central Ltd.

                This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 August 2013
                : 11 October 2013
                Categories
                Study Protocol

                Medicine
                cognitive computer games,home-based training,manual wheelchair,older adults,rehabilitation

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