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Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels)… Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H Oct 24, 2013

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STUDY PROTOCOL Open AccessFeasibility of the Enhancing Participation In theCommunity by improving Wheelchair Skills(EPIC Wheels) program: study protocol for arandomized controlled trialEdward M Giesbrecht1*, William C Miller1, Janice J Eng2, Ian M Mitchell3, Roberta L Woodgate4and Charles H Goldsmith5AbstractBackground: Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, trainingon 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 ImprovingWheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in oldernovice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose ofthis study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheelsprogram 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 wheelchairmobility skills between an EPIC Wheels treatment group and a computer-game control group, with additionalwheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicatorsrelated to study process, resources, management, and treatment issues will be collected during data collection andat the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collectedat baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skillcapacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures includewheelchair 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 forclinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherencefor older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinicaloutcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses.Trial registration: Clinical Trials NCT01740635.Keywords: Cognitive computer games, Home-based training, Manual wheelchair, Older adults, Rehabilitation* Correspondence: Ed.Giesbrecht@med.umanitoba.ca1Department of Occupational Science and Occupational Therapy, Universityof British Columbia, Vancouver, CanadaFull list of author information is available at the end of the articleTRIALS© 2013 Giesbrecht et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.Giesbrecht et al. Trials 2013, 14:350http://www.trialsjournal.com/content/14/1/350BackgroundCanada has a rapidly growing aging population; over thenext 50 years, the proportion of older people is expectedto double to more than one in four [1]. With age, the riskof a disabling health condition increases; mobility is themost prevalent area of impairment among older adults inCanada [2]. The number of wheelchairs provided to ad-dress mobility issues among older adults is also rising. In2001, an estimated 81,000 Canadians 65 years and olderrequired a wheelchair for mobility [3] – a rate four timesthe national average. A 2004 study [4] reported thatamong multiple assistive device users, the manual wheel-chair (MWC) was considered third most important, be-hind eyeglasses and canes. However, the wheelchair alsorepresents a substantial cost to consumers and the healthcare system. Beyond the cost of purchase, which variesfrom several hundred to thousands of dollars, our clinicalexperience has demonstrated that the process of assess-ment, procurement, fitting, and delivery can reach $10,000or more. These systemic costs are squandered if olderadults are unable to use their wheelchair effectively to par-ticipate in important activities of life.Merely acquiring a wheelchair does not guarantee inde-pendence or satisfactory performance with functional ac-tivities. In particular, environmental factors, such as carpet,ramps, curbs, gravel, and poor sidewalk conditions, presentbarriers to mobility and self-propulsion. In Canada, over90% of older MWC users experienced restricted perform-ance in at least one major life activity [2] (compared with15% of those without a mobility device) and nearly 60% re-quire assistance from a family member or other care pro-vider for even basic mobility [3]. Restricted mobility isassociated with reduced participation and a loss in socialconnectedness [5], which can lead to feelings of isolation,stress, and low self-esteem, impacting overall quality of life[6]. A 2006 study of stroke survivors adjusting to wheel-chair use identified substantial restriction in caregivers’ so-cial roles and an increased burden of care [7]. In Canada,25% of caregivers of the elderly are over 65 years them-selves [1], and risk both acute and overuse injury whenassisting with wheelchair use [8].In addition, MWC users are at risk of tips and falls,which often result in injury. In Canada, the yearly inci-dence of tips or falls is estimated to be 5.2%, with 4.2%resulting in injury and 2.5% requiring a visit to an emer-gency department [9]. In the United States in 2005,wheelchair-related accidents resulted in one death perweek and treatment for a hospitalized injury was estimatedat $25,000 to 75,000 [10].Providing comprehensive skills training is effective, butrelies on considerable 1:1 training time. The WheelchairSkills Training Program [11] is the only structured trainingprogram reported in the literature. An expert clinicianprovides personal training, typically requiring four to eightsessions of an hour or more. Several studies have demon-strated the Wheelchair Skills Training Program to be safeand practical [12,13], and randomized controlled trials re-port a significant improvement in skill capacity amongadult MWC users during inpatient rehabilitation [14] andin the community [15]. Improvements in safety with skillperformance have also been reported [16]. While the evi-dence indicates such training is effective, there has not beenwidespread clinical adoption and as a result older adults re-ceive little or no structured wheelchair skills training. Evenamong younger populations receiving inpatient rehabilita-tion, only 17 to 18% of wheelchair users receive any formaltraining [17,18], which typically focuses on such skills astransferring from the wheelchair to the bed, toilet, or bath-tub. A survey of older veterans who were prescribed awheelchair post-stroke found 53% had received no instruc-tion at all on wheelchair use [19]. Another study of US vet-erans reported that more than 50% had difficulty with evenbasic wheelchair propulsion, despite having access to atrained clinician and a custom-fitted wheelchair [20].Several factors contribute to the current situation of in-adequate training. First, many clinicians do not have suffi-cient knowledge of (or ability to demonstrate) wheelchairskills [12]. Second, other competing demands are oftenprioritized over wheelchair training during in-hospital re-habilitation. Older adults are frequently discharged with atemporary (standard) wheelchair and delivery of a custom-ized wheelchair occurs in community settings, when ther-apists’ time is limited. Finally, funding for home care andcommunity-based services in Canada and the UnitedStates has been in decline and is insufficient to supportclinician-intensive training either before or after discharge[21,22]. Often, the time and travel demands for both con-sumers and clinicians make traditional skills training cost-prohibitive [23]. Long wait lists and the inaccessibility ofrehabilitation services, particularly in rural areas, furtherexacerbate the problem [23,24].Delivering rehabilitation training as a monitored or self-managed home program among older adults has been ef-fective for a variety of outcomes including strengthening[25], physical activity [26], self-care [21,27] and exercise[28,29]. Home programs are advantageous because theyallow privacy for the user, occur in a familiar context, canbe conveniently integrated into the user’s schedule, and donot require the time, effort, and expense of travel [26]. Ad-herence to any intervention is critical to its effectiveness. A2010 Cochrane review of exercise interventions found thoseinterventions that incorporated social cognitive theory (thatis, self-efficacy), were monitored, and increasingly gradedcomplexity of the activity were more effective in improvingadherence, frequency, and duration of exercise [30].Computer-related devices are becoming increasinglyuseful for rehabilitation interventions, with advances in af-fordability, size, portability, accessibility, and user-interfaceGiesbrecht et al. Trials 2013, 14:350 Page 2 of 11http://www.trialsjournal.com/content/14/1/350simplicity. Computer and popular gaming systems haveshown promising results in rehabilitation by casting ther-apy in a more engaging and enjoyable context. Their usefor physical activity training in rehabilitation among olderadults has demonstrated high participation rates, in-creased motivation, and tolerance for activity, and trendstoward improvement in fitness [31].The Enhancing Participation in the Community by Im-proving Wheelchair Skills program (EPIC Wheels) is an in-dividualized home training program that optimizes learningfor older adults while limiting the time demands of experttrainers. The program content and delivery was developedusing principles of andragogy (adult learning) [32,33] andsocial cognitive (self-efficacy) [34,35] theory. Using an af-fordable computer tablet device, EPIC Wheels provides acustomized and mobile structured training program for in-chair or tabletop use at home and in the community. Atouch-screen audiovisual display features interactive train-ing and practice activities, and wireless Internet connectiv-ity enables trainee-trainer communication and remotetrainer monitoring. The EPIC Wheels program is 1 monthlong and includes a minimum of 10 hours of training andpractice. Training includes two personalized sessions with awheelchair expert; one at the outset and the second at themid-point of the program.Prior to moving to a large-scale randomized controlledtrial (RCT), it is not only critical but also prudent to en-sure that the feasibility indicators and the proposed clin-ical measures are sufficiently robust. This paper describesthe objectives and design of the EPIC Wheels feasibilitystudy that will be used to construct and implement a com-prehensive, multi-site RCT trial that directly assesses theguiding hypotheses.Study objectivesFeasibility indicatorsThese have been selected to assess the feasibility of studymethods and procedures, including: Process issues of subject recruitment, consent,retention, and perceived benefit. Resource issues of treatment adherence, burden ofdata collection, incorporating a health utility index,and intervention burden. Management issues of tablet reliability, subjectprocessing, and protocol administration. Treatment issues of safety, response, and treatmenteffect.Primary clinical outcomeThe aim of the study is to evaluate the effect of EPICWheels on wheelchair skill capacity and obtain an esti-mate of the treatment effect size.Secondary clinical outcomeThe secondary aims are to evaluate the effect of EPICWheels on wheelchair skill safety, wheelchair use confi-dence, satisfaction with activity performance, mobility,divided-attention, and health-related quality of life.Methods/designTrial designThis study uses a two-site RCT to compare differences inolder adults’ wheelchair mobility skills between an EPICWheels (treatment) group and a cognitive training (control)group, introducing ‘extra wheeling’ as a second factor.A 2 × 2 factorial design randomly assigns subjects using a1:1:1:1 allocation ratio between four groups: EPIC Wheels,EPIC Wheels with extra wheeling, cognitive training, andcognitive training with extra wheeling. To support balancebetween groups and masking of assignment, a central com-puterized randomization algorithm was designed by ourstatistician, with an undisclosed block size and stratified bysite (n = 20 at each site). Once subjects are enrolled, a testercollects baseline data before a study coordinator contactsthe statistician to obtain group assignment. A trainerwill initiate contact with the subject and implementthe 1-month program, after which time the tester willre-administer the outcome measures (see Figure 1). Toaddress bias, subjects will be instructed not to discusstheir program; separate trainers will be used for the treat-ment and control groups at each site; and testers will beblinded to group allocation. A protocol is included forcontrol group trainers to identify the potential value of thecontrol intervention for wheelchair mobility and strategiesto prevent participant attrition.EthicsThe protocol for this study has been approved by theResearch Ethics Boards at the University of BritishColumbia (Approval number, H12-02043) and the Universityof Manitoba (Approval number, HS15818), as well as the re-search review committee of the regional health authority foreach site. All study subjects, and their caregivers, will provideinformed consent prior to enrolment. The study wasfunded through a peer-reviewed operating grant fromthe Canadian Institutes of Health Research (MOP-123240).ParticipantsA total of 40 community-dwelling MWC users living intwo Canadian cities (20 at each site) will be recruited on avoluntary basis. Each site will have 20 participants, with fiveparticipants in each of four groups: treatment with extrawheeling, treatment without extra wheeling, control withextra wheeling, and control without extra wheeling. Tooptimize the impact of the treatment, individuals with lessthan one year of MWC use will be recruited. Novice usersare still developing routines and patterns of wheelchair useGiesbrecht et al. Trials 2013, 14:350 Page 3 of 11http://www.trialsjournal.com/content/14/1/350and are potentially more amenable to adapting their mobil-ity techniques [12]. Subjects will be ≥55 years old; live inthe community within the metropolitan boundaries; self-propel a MWC ≥1 hour/day; use their MWC for mobilityinside and outside their home; have used a MWC for <1year; and have a caregiver willing to attend training sessionsand supervise home training. There are no specific diagnos-tic criteria for enrolment; however, subjects must be able topropel a wheelchair with both hands. Individuals will be ex-cluded if they cannot communicate and complete studyquestionnaires in English; anticipate a health condition orprocedure that contraindicates training (for example, sur-gery scheduled which would impair physical activity); or arecurrently receiving outpatient therapy that includes wheel-chair mobility training. A caregiver for each participant willalso provide consent to participate in the study, and bothsubject and caregiver will indicate whether they are willingto be contacted for follow-up after the study is complete.Sample sizeTo address the feasibility indicators, the number of sub-jects is large enough to represent the target populationand assess the feasibility criteria [36]. In addition, the sam-ple size is powered to detect a statistically significant differ-ence between groups and provide a reasonable estimate ofa treatment effect. With a 2 × 2 factorial design, samplesize can be calculating using each main factor independ-ently, and then determined by selecting the larger of thetwo estimates [37]. Our calculations are based on the pri-mary clinical outcome measure (the Wheelchair Skills Testversion 4.1, WST), as this will be used in subsequent EPICWheels studies. Research in the field of wheelchair skillstraining is still maturing, with three published studies usingactual users, and given the novel home program approachan α of 0.10 was selected to ensure a potentially beneficialtreatment effect would not go undetected (Type I errorrate). Given the absence of data regarding the impact ofextra wheeling, we opted to use a comparable effect size(f = 0.54) in the second factor calculation. To minimize therisk of identifying such an effect merely by chance (Type IIerror), the study is powered at 90%. Based on a sample sizecalculation for analysis of covariance (ANCOVA) each ofthe four groups would require eight subjects for a total of32 participants. In previous Canadian trials, a 9 to 18%Treatment Group Control GroupExtra WheelingNon-Extra WheelingExtra WheelingNon-Extra WheelingTraining Session #1 Training Session #1Training Session #2 Training Session #2HomeTrainingProgram(2 weeks)HomeTrainingProgram(2 weeks)Follow-upPhone callStudy TesterCoordinatorTrainer #1 Trainer #2Study Tester (blinded)Week 1Week 2Week 3Week 4Follow-upPhone callFollow-upPhone callHomeTrainingProgram(2 weeks)HomeTrainingProgram(2 weeks)Follow-upPhone callFigure 1 Trial procedure.Giesbrecht et al. Trials 2013, 14:350 Page 4 of 11http://www.trialsjournal.com/content/14/1/350dropout rate has been reported; conservatively adjustingfor a 25% dropout rate (32/0.75), a total study N of 44 isplanned (n = 11 for each group).Previously published studies have used younger ormixed age populations; data specific to older adults arenot available. We obtained permission to use a data subset(adults >50 years) from a yet-to-be published study(F Routhier, personal communication) that providedWST change scores following training and powered ourstudy to capture a comparable change (m = 9.3%; s = 9.5%).A difference of 9.3% corresponds to an acquisition of threeadditional skills on the WST; previous studies report thatsubjects perceive a clinically important difference with suchimprovements [17,18]. In fact, the skills performed on theWST are sequenced from simple (for example, rollingforwards) to moderate (for example, propelling on carpet)to complex (for example, ascending a 10° ramp). Researchliterature reporting on MWC use among older adults spe-cifically implicates carpet, inclines, curbs, gravel, and poorsidewalk conditions as barriers to independent mobility [7].Acquisition of even one of these important skills couldquite reasonably represent a minimally clinically importantdifference (MCID) to wheelchair users, their caregivers,and those providing training. No formal MCID has beenestablished for the WST; however, using data from aCanadian trial [18], a smallest detectable differencecalculation suggests that a difference of 9.2% wouldexceed any measurement error or noise [38]. A reliabilitychange index calculation indicates that 3.0% is theminimal detectable change required and is a reasonableproxy for MCID [38].ProcedureSubjects attend an initial session with their respectivetrainer for 90 to 120 minutes, including orientation to thecomputer tablet. Subjects are provided with a preparedstudy tablet and printed reference handbook to engage intheir home training program for 2 weeks, with a minimumof 150 minutes of tablet-based activity per week. After 2weeks, subjects attend a second session with their trainerfor 60 to 90 minutes and then continue with their hometraining program for an additional 2 weeks. The trainermakes follow-up telephone contact at the end of weeks 1and 3.Extra wheelingThe EPIC Wheels program requires trainees to engage inwheelchair activity that they might not otherwise under-take. While it is unlikely that such additional wheelchairuse alone would substantially increase skill acquisition orproficiency, to address this potentially confounding vari-able subjects are randomly allocated into extra wheelingand non-extra wheeling subgroups. Subjects in the extrawheeling subgroups are asked to perform an additional 75minutes of unstructured wheelchair wheeling per week,which can occur in their home or in the community. Extrawheeling is defined as participants propelling their wheel-chair in addition to what they would typically do in thecourse of daily activities. For these subjects, the trainingtablet presents a prompting question every 24 hours askinghow many minutes of extra wheeling they have performed.Subjects toggle up and down in 5-minute increments andenter their data before the tablet returns to the training ac-tivities. Trainers can encourage subjects to increase theirextra wheeling activity during follow-up phone calls andtraining visits if target levels have not been met.InterventionTreatment group (EPIC wheels)EPIC Wheels trainers are occupational therapists with ≥5years of clinical experience in wheelchair provision andtraining, who have received a 2-day comprehensive orien-tation program. Each training session is administered usinga protocol and checklist. Trainers select a subset of skillsand training activities to incorporate into the home train-ing program based on ability, safety, and relevance for thesubject. The EPIC Wheels home program includes a com-prehensive, structured library of educational material andtraining activities, organized in a hierarchy from simple tocomplex. Trainers monitor a subject’s progress throughonline access to tablet usage data and re-assessment duringthe second training session, revising the home programwith more advanced skills and activities.The home program component is delivered using a 10-inch (≈25 cm) portable ASUS® computer tablet (ASUSTek,Markham, ON). The tablet is menu driven and interactive,using a touch-screen interface. Training is provided in amulti-modal format with illustrations and videos, allowingdetailed step-by-step guidance and slow-motion demon-strations. Female and male actors, both close to 70 yearsof age, were used to provide age-appropriate models in thevideos. Practice activities can be clearly demonstrated andinclude imitative, function-based, and interactive game-related activities. The tablet is mounted on a rigid plat-form with a simple strap that wraps around the subject’sthighs for use in a wheelchair. A ‘progress’ icon providesdaily updates on the number of minutes practiced perweek to reinforce adherence. Subjects can exchange voice-mail with their trainer using an integrated applet. Subjectsreceive a mobile Internet device for voicemail and datatransfer or update capability, but the tablet operates as asingle-function device with all other applications disabled.Control group (cognitive training)Control group subjects also attend two sessions with theirtrainer to address attention balance through exposure tostudy personnel. In addition, they receive an identical tab-let pre-loaded with computer games to account for tabletGiesbrecht et al. Trials 2013, 14:350 Page 5 of 11http://www.trialsjournal.com/content/14/1/350device and activity exposure. Nine different games addressproblem solving (for example, Tetris, Cogs); word, math,and memory challenges (for example, Scrabble, Sudoku);and dexterity or response skills (for example, Marble Saga,Cut the Rope). Each training session is administered usinga protocol and checklist. During the first session, the trainerdiscusses the potential benefits of computer-game trainingon cognition and motor function, and how these can posi-tively impact wheelchair mobility. Trainers provide anorientation to the cognitive games and operation of the tab-let device. During the second session, the trainer discussessubjects’ current community activities and experience usingthe wheelchair via a structured discussion guide, and pro-vide verbal information related to barriers encountered, aswell as any additional review or training related to the cog-nitive training games. To minimize attrition and providewheelchair skill-specific information, the consent form in-forms control group subjects that they will receive a DVDwith a condensed EPIC Wheels education program afterthe post-intervention data collection is complete.Training scheduleThe home training schedule for both groups targets a mini-mum of 1 or 2 sessions/day, 15 to 30 minutes in length, atleast 5 days per week (minimum 150 minutes/week). Theseguidelines are based on the National Blueprint consensusdocument on promoting physical activity for adults over 50years, which advocates that lifestyle- or endurance-relatedactivity of moderate intensity should be undertaken for atleast 30 minutes (in bouts of at least 10 minutes) 5 to 7days per week [39]. The minimum training time is at leastcomparable to 1:1 training time in other clinical studiesusing structured wheelchair skills training, where a signifi-cant improvement in skill capacity was observed [17-19].Adherence to this schedule is achievable, as demonstratedby a study of home-based training program for improvinghand function among stroke survivors (n = 77; m = 57years) which obtained 96% compliance for 1.3 hours oftraining per day, 7 days per week over 5 weeks [40].SafetyThe EPIC Wheels program incorporates extensive safety-related material, including teaching the safest mobilitystrategies; use of safety equipment; recognizing unsafe situ-ations; and seeking assistance when skills are insufficient toaddress environmental barriers. At the initial training ses-sion, subjects are provided with protective wheeling gloves.Caregivers attend and participate in both training sessionsand encouraged to supervise home training activities. A fit-ted spotter’s strap and demonstration and instruction areprovided for caregiver use during training to preventwheelchair tips. Operating a wheelchair in the communitycarries innate risks that cannot be entirely eliminated; how-ever, EPIC Wheels offers education and training designedto minimize risks of wheelchair operation. This knowledgeshould reduce the risk of a fall or injury that subjects mightbe exposed to in their everyday use of a MWC had theynot received this program. Any unsafe performance ob-served during training is addressed immediately with cor-rective feedback. Subjects are encouraged to contact thecoordinator immediately if they experience unusual dis-comfort, pain, or physical symptoms. A data and safetymonitoring board, consisting of a statistician, a physiatrist,and a physical therapist, review accumulating indicatordata and advise the investigators regarding safety issues,evidence of benefit, and need for modification to the studydesign [41]. Adverse events are documented by the trainerand reported to the data and safety monitoring board andthe ethics review board.Computer technology uptakeThe use of a computer tablet to deliver the home trainingprogram offers advantages of portability, audiovisual versa-tility, flexible configuration, and real-time updating. Al-though older adults are less likely than younger people toembrace technologies, such as computers, their use ofcomputers continues to grow. Studies in the United Statesbetween 2006 and 2010 found 84% of those over 60 yearshad experience with computers [42] and 40% of those over65 years are regular computer and Internet users [43]. Useof a tablet involves some new learning, and age-related de-clines in memory and fluid intelligence may restrict uptake.These issues are addressed through self-paced training,structures for successful experiences to build confidence,and by adapting the interface for familiarity and ease of usewith minimal memory requirements [44,45]. Consumer,caregiver, and clinician input were incorporated during theEPIC Wheels program development to ensure the deliveryformat addresses these concerns.Data collectionAt baseline, wheelchair device characteristics are collectedusing a modified wheelchair specification form [46]. De-scriptive characteristics including age, sex, marital status,highest level of education, primary diagnosis related toMWC use, length of time using the MWC, and propulsionmethod are collected along with cognitive status measuredusing the Standardized Mini-Mental Status Exam [47].Handgrip strength has been demonstrated to be an accur-ate surrogate measure of overall strength [48] and is mea-sured using a JamarTM 5030J1 dynamometer (SammonsPreston Rolyan, Chicago, IL).Feasibility indicators for process, resources, management,and treatment characteristics are collected during study ad-ministration and at the study’s end. Process indicators in-clude recruitment, consent, and retention rates at each site.Retention is a critical factor for subsequent clinical trials;follow-up with all discontinued participants regarding theirGiesbrecht et al. Trials 2013, 14:350 Page 6 of 11http://www.trialsjournal.com/content/14/1/350reason for dropout will inform future study design andsample size calculations. A post-treatment participant ques-tionnaire is used to evaluate perceived benefit. Resource in-dicators are monitored by tracking study staff time logs andtablet usage data. Management issues are evaluated using atrainer evaluation form and by tablet reliability or loss data.Treatment indicators include reporting of adverse eventsand statistical analysis of the treatment effect.The clinical outcome measures are collected at baseline(pre-randomization) and post-treatment (1 month). Theprimary outcome is wheelchair skill capacity, measuredusing the Wheelchair Skills Test 4.1 (WST) [14]. The WSTis a structured assessment with 32 discrete mobility skillsrequired to perform social roles in the community, eachscored dichotomously as pass or fail, producing a total skillcapacity score (0 to 100%) with a higher score reflectingmore skills acquired. The WST is sufficiently sensitive todetect proximal effects of training; can be completed in ap-proximately 30 minutes; and does not demonstrate floor orceiling effects [16]. Two systematic reviews of availablewheelchair skill outcome measures confirmed that theWST has the strongest psychometric properties and hasbeen used most extensively in clinical trials [49,50]. TheWST has demonstrated reliability for test-retest (intraclasscorrelation coefficient (ICC) = 0.90), intra-rater (ICC = 0.96),and inter-rater (ICC = 0.97) administration [16]. Con-struct validity has been supported by significant rela-tionships with predictive variables of age, sex, MWCexperience, diagnosis, and use of a lightweight wheelchair,which together accounted for 35% of variability in WSTscore using multiple regression (adjusted R2 = 0.35) [16].Concurrent validity has been established through positivecorrelation with two criterion measures: therapists’ globalassessment of user ability (RS = 0.39 - 0.40) and theFunctional Independence Measure (admission scoreRS = 0.38; discharge score RS = 0.31) [16,51].Secondary clinical outcomes reflect more distal impactsof the intervention. Given the dearth of evidence in the lit-erature, there is substantial value in understanding the re-lationship between skill acquisition and safety, confidence,community participation, mobility, and utility. Seven sec-ondary measures contribute to discerning a clinically im-portant impact of the EPIC Wheels intervention. WST 4.1 skill safety. The WST also provides a totalskill safety score (0-100%) reflecting the number ofskills addressed in a safe manner (higher scoreindicates greater safety), regardless of whether theskill is acquired or not. This is of considerableimportance, since training also involves learning torecognize risks and limitations. Wheelchair Outcome Measure (WhOM). Therehabilitation literature strongly suggests the use ofmeasures of user-identified activities of relevanceand perceived satisfaction with performance [52-54].Using an interview format, MWC users are asked toidentify relevant activities and rate them for bothimportance and satisfaction, using an 11-point scale(0 to 10), with higher scores indicating greaterimportance or satisfaction. The WhOMdemonstrates reliability and validity in use amongolder adults (Test-retest ICC = 0.77 to 1.00;correlation with QUEST [55] rs = 0.36 to 0.45) [56]. Wheelchair Use Confidence Scale for ManualWheelchair Users (WheelCon-M 3.0). Self-efficacyhas been identified as a key component in theperformance of wheelchair mobility skills [57] andpreliminary research has suggested that standardizedtraining can increase wheelchair confidence amongolder adults [58]. The WheelCon is a self-reportquestionnaire composed of 65 statements related toconfidence using a wheelchair in activities andenvironments, each rated on a scale from 0 (notconfident) to 100 (completely confident), producinga total mean score of 0 to 100 [59]. A 2010 studyevaluated test-retest reliability (ICC = 0.84) andsignificant correlation with comparison measuressupporting its validity [60]. Life-Space Assessment (LSA). The LSA is a 20-itemquestionnaire that tracks the wheelchair user’s travelon a continuum of five environments from thehome to outside of town [61], and capturingmobility habits over a 4-week period, includingfrequency of travel and level of assistance required.Scores vary from 0 to 120 and are weighted forfrequency and level of assistance, with higher scoresreflecting further distance from home, greaterfrequency of travel, and less assistance required.Evaluation of the LSA among power wheelchair usersfound excellent test-retest reliability (ICC = 0.87) [62]. Health Utility Index Mark 3 (HUI3). Health utilitymeasurement is useful in performing cost-utility andcost-effectiveness analyses of new rehabilitationinterventions. National guidelines for healthcareeconomic analyses strongly advocate the use of avalidated measure of health-related quality of life,which can be converted to quality-adjusted life yearsgained, so as to fully inform funding decisions [63].The HUI3 is a brief questionnaire that asks subjectsabout their health status, deriving both single- andmultiple-attribute utilities to ascertain quality-adjusted life years [64], and meets the criteria for avalid health-related quality-of-life utility score [65].Each single-attribute utility is scored between 0.00and 1.00 and the multiple-attribute utility scale isscored from −0.36 to 1.00, with higher scoresreflected better health and quality of life. Our studyis not sufficiently powered to undertake a cost-utilityGiesbrecht et al. Trials 2013, 14:350 Page 7 of 11http://www.trialsjournal.com/content/14/1/350analysis, but will determine the feasibility ofcollecting cost-utility data in a larger RCT andestimate what changes in health-related quality oflife might be anticipated. Wheeling While Talking test (WheelTalk).Wheelchair mobility is a complex skill and prone torisk of tips, falls, and potential injury, particularlywith older adult users, where motor and cognitivefunction may decline with age. The WheelTalk is anew divided-attention assessment for wheelchairusers. Scoring reflects the additional number ofseconds required to complete a slalom courseduring the dual-task versus motor task-onlycondition, with a larger time differential indicatingpoorer performance. Initial evaluation with residentsin a long-term care facility demonstrated reliabilityfor test-retest (ICC = 0.92), intra-rater (ICC = 1.00)and inter-rater (ICC = 1.00) administration [66].Collecting data in this study will allow investigationof associations between performance and wheelchairskill, safety, and other demographic factors,contributing to validation of this tool. Data logger. To capture level of activity while in thewheelchair, a data logger (three-axis self-recordingaccelerometer X16-1C, Gulf Coast Data Concepts,Waveland, MS) is mounted on the drive wheelspokes of each subject’s wheelchair. The data loggeris a small, unobtrusive ‘black box’ that collects drivewheel movement via an accelerometer over a periodof 6 to 10 days. Distance travelled and bouts oftravel will be calculated, with larger values reflectingmore activity. Collecting these data will allowdescription and comparison of wheeling patternsand extent of activity among participants. Dataloggers are installed at the first training session andremoved at the second training session,approximately 2 weeks later.Statistical analysesStudy analyses will consider study feasibility indicators aswell as clinical (statistical) outcomes. Means and standarddeviations (for continuous variables) and frequencies andproportions (for categorical variables) will be used tosummarize case mix and outcome variables for groups.Qualitative comparison of variable balance will be made,including determination of prognostic importance [36].Descriptive statistics of training time and number of train-ing sessions (collected via tablet usage data) will be usedto evaluate adherence and explore potential associationsbetween training intensity and measured outcomes.A detailed description of the feasibility indicators andmeasurement criteria is provided in Additional file 1.Feasibility indicators will be treated as binary, with‘success’ indicating that the protocol is sufficiently robustto move forwards with the large RCT with only small orno adaptation required, and ‘revise’ indicating a need formore substantive change before proceeding. The numberand extent of objectives requiring revision will determinewhether the feasibility study data can be conflated withthose produced in a larger subsequent RCT.Post-treatment WST skill capacity scores will be com-pared in the treatment and control groups using analysis ofcovariance (ANCOVA), controlling for baseline score as acovariate for the primary analysis [67]. Borm et al. [68]demonstrate that correlation between pre- and post-intervention scores (ρ) influences analysis power; when ρ >0.5, change score is more powerful than direct post-intervention comparison. However, when ρ lies between0.2 and 0.8, ANCOVA (controlling for baseline score) fur-ther reduces the required sample size by 10 to 40% overchange score. Given that preliminary data suggest ρ ~ 0.5(F Routhier, personal communication), ANCOVA shouldprovide the most powerful analysis, in addition to reducingerror variance and allowing modification when statisticalassumptions are not met [69]. Unequal cell sizes will be ac-commodated using Method 1 adjustment [70] and diagnos-tic assessments made for model assumptions. Significancetesting (P) and marginal means with 95% confidence inter-vals will be estimated. Effect size (partial η2) will be calcu-lated as a ratio of the effect and total sums of squares, witha 95% confidence interval. To preserve prognostic bal-ance, primary analysis will be based on intention totreat; however, since one objective is to estimate thetreatment effect, secondary analysis on a per-protocolbasis (subjects who adhere to treatment) will also beconducted, for comparison [71].One argument for potential improvement in wheelchairskills using the EPIC Wheels program is the inducementof subjects to use their wheelchair more, rather than thespecific content of the training program. Our factorial de-sign, with extra wheeling as a second factor, will attemptto address this question. Initial analysis will contrast thetwo main effects: training (EPIC Wheels versus cognitivegames) and extra wheeling (yes versus no). Secondary ana-lysis of the interaction contrast between factors may delin-eate whether additional wheeling has a synergistic orantagonistic effect on the training program.ANCOVA will be used to compare post-treatment scoresbetween groups for WST skill safety, wheelchair confidence(WheelCon), safety risk (WheelTalk), and mobility (LSA)as a secondary analysis. In each case, baseline score will beused as a covariate. Subjects’ satisfaction with performanceof meaningful activities (WhOM score) will be analyzedusing analysis of variance (ANOVA). Mean administrationtime for the HUI3 will be calculated and a preliminaryevaluation of change in the treatment group will be con-ducted. Endpoints and change analyses will also be con-ducted to compare their precisions with ANCOVA.Giesbrecht et al. Trials 2013, 14:350 Page 8 of 11http://www.trialsjournal.com/content/14/1/350Summary and descriptive statistics for distance and speed(mean and standard deviation) and bouts of activity(counts) will be calculated for the data logger data.DiscussionThe EPIC Wheels study is intended to establish the feasibil-ity of a novel intervention designed to improve wheelchairskills and safety among older adult manual wheelchairusers. The EPIC Wheels program is innovative in severalrespects. First, it offers evidence-based skills training in ahome training format that has greater potential for clinicaluptake. While structured training has been demonstratedto improve skill capacity, access to and related costs of one-on-one training with an expert clinician has restricted wide-spread adoption. Consolidating the majority of training in ahome program with remote electronic monitoring by theclinician makes for a more viable option from an economicand convenience standpoint. Second, EPIC Wheels has atheory-driven design to increase effectiveness among olderadults and enhance program adherence, explicitly incorpor-ating principles of social cognitive theory (self-efficacy) andandragogy (adult learning) into the content and deliveryformat. In addition, older adult stakeholder groups includ-ing MWC users, their caregivers, and clinician trainers,were intimately involved during the 1-year program devel-opment process. Research related to capacity and a prin-cipled teaching method for older adults to learn wheelchairmobility skills is sparse, and this study may provide import-ant new evidence. Third, the use of commercially availableand relatively inexpensive tablet technology provides a flex-ible and versatile mobile training interface. Trainees canpractice with the tablet on their wheelchair in their homeor community environment and communicate remotelywith their trainer, while clinicians can monitor training ac-tivity and communication through a web-based interface attheir convenience. Finally, the factorial study design willallow broader inferences about the contributions of in-creased wheelchair activity and the specific attributes of theEPIC Wheels training program, as well as an interactionbetween these factors.Owing to the nature of feasibility studies, several inherentlimitations arise and will be addressed in the larger multi-site RCT study to follow. The potential for recruitment ofnovice older adult MWC users is unknown: this is an im-portant feasibility indicator to address for future planning.Assessment of skill retention will not be addressed at thisstage. Control group subjects may be more likely to dropout. Providing control group trainers with structured strat-egies to maintain subject enthusiasm; weekly subjectcontact; engaging and fun cognitive computer games, andprovision of a condensed training DVD at the study conclu-sion will help mitigate this risk. Demonstration of atreatment effect may lack generalizability, owing to the re-stricted age group being targeted. Age is inversely related tomotor skill acquisition, including wheelchair mobility skills.We anticipate that a training program proven to be effect-ive with older adults should have at least as large a treat-ment effect in younger and stronger individuals; however,this assumption is as yet untested.The feasibility indicators of this study will be used toconstruct and implement a comprehensive, multi-site RCTtrial that directly measures the guiding hypotheses. Thissubsequent study will address skill retention using a 6-month follow-up evaluation. A large RCT will directly ad-dress evaluation of important changes in wheelchair skilland safety; wheelchair use confidence; mobility and com-munity participation; and cost-effectiveness. Evidence forthe effectiveness of EPIC Wheels would inform clinicalbest practice and provide justification for a pilot projectwhere a single trainer coordinates service to a large groupof wheelchair users across a broad geographical area. EPICWheels has great potential for use across age and diagnos-tic groups, including training for individuals who live inrural and remote locations where access to rehabilitationprograms is not practical. EPIC Wheels provides versatility,as it can be delivered on multiple platforms including com-puters, tablets, smart phones, and traditional DVD. Fur-thermore, the inherent capacity of the tablet device (that is,GPS, accelerometers) can be incorporated into future EPICWheels versions to collect real-time user data on wheel-chair performance; to create interactive training activitiesor games; to evaluate skill performance; and integrationwith other commercially available technology.Trial statusApproval has been obtained from the university ResearchEthics Boards and regional health authority ResearchReview Committees at both sites. All study staff havebeen hired and trained at both sites and recruitmentis currently underway.Additional fileAdditional file 1: Detailed description of feasibility indicators andmeasurement criteria.AbbreviationsANCOVA: Analysis of covariance; ANOVA: Analysis of variance;EPIC Wheels: Enhancing participation in the community by improvingwheelchair skills; HUI3: Health utilities index mark 3; ICC: Intraclass coefficient;LSA: Life-space assessment; MCID: Minimally clinically important difference;MWC: Manual wheelchair; RCT: Randomized controlled trial;WheelTalk: Wheeling while talking test; WhOM: Wheelchair outcomemeasure; WST: Wheelchair skills test, version 4.1.Competing interestsThe authors declare that they have no competing interests.Authors’ contributionsWCM was responsible for administration of the grant, oversight of the study,and first site lead. JJE provided guidance with the research design andimplementation. IMM was instrumental in the development of the tabletGiesbrecht et al. Trials 2013, 14:350 Page 9 of 11http://www.trialsjournal.com/content/14/1/350software applications and provided ongoing technology design and support forthe computer tablet software application. CHG provided expertise in the RCTdesign and analysis as well as cost-utility and cost-effectiveness evaluation. RLWcontributed to the program evaluation and development research phase. EMGwas primarily responsible for development of the intervention, pilot testing, andthe second site lead. EMG wrote the first draft of the manuscript and all authorsreviewed and contributed to the final version.AcknowledgementsThis study was funded by an operating grant from the Canadian Institutes ofHealth Research (MOP-123240). EMG is supported by a doctoral fellowshipfrom the Canadian Institutes of Health Research.Author details1Department of Occupational Science and Occupational Therapy, Universityof British Columbia, Vancouver, Canada. 2Department of Physical Therapy,University of British Columbia, Vancouver, Canada. 3Department of ComputerScience, University of British Columbia, Vancouver, Canada. 4Faculty ofNursing, University of Manitoba, Winnipeg, Canada. 5Faculty of HealthSciences, Simon Fraser University, Burnaby, Canada.Received: 14 August 2013 Accepted: 11 October 2013Published: 24 October 2013References1. Cranswick K, Dosman D: Eldercare: What We Know Today. Ottawa: StatisticsCanada; 2008. Catalogue no. 11–008.2. Statistics Canada: Participation and Activity Limitation Survey 2006: LabourForce Experience of People with Disabilities in Canada. Ottawa; 2008.Catalogue no. 89-628-X.3. Shields M: Use of wheelchairs and other mobility support devices.Health Rep 2004, 15:37–41.4. 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Moncur R, Larmer J: Clinical applicability of intention-to-treat analyses.McMaster Univ Med J 2009, 6:39–41.doi:10.1186/1745-6215-14-350Cite this article as: Giesbrecht et al.: Feasibility of the EnhancingParticipation In the Community by improving Wheelchair Skills(EPIC Wheels) program: study protocol for a randomized controlled trial.Trials 2013 14:350.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitGiesbrecht et al. Trials 2013, 14:350 Page 11 of 11http://www.trialsjournal.com/content/14/1/350

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