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Difficulty WalkingNCT01740635

EPIC WheelS Feasibility Study

A study testing EPIC WheelS Training Program in people with Difficulty Walking, run by University of British Columbia at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many older adults have difficulty walking. A wheelchair can improve their participation but older adults typically receive little wheelchair training. Structured training programs are effective but rely on multiple 1:1 sessions with a skilled clinician. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Difficulty Walking
What is being tested?
EPIC WheelS Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesCanada
Study dates
Mar 2013to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Wheelchair users must
  • be at least 50 years old
  • use his/her wheelchair for at least 1 hour per day on average
  • live within the metropolitan boundaries of Vancouver or Winnipeg
  • have a caregiver who is able to attend training sessions and supervise home training
  • Caregivers must
Show all 10Show fewer
  • be 19 years old or older
  • be a caregiver of a manual wheelchair user who is 50 years or older
  • able to attend the training sessions
  • be able to supervise or spot the wheelchair user during home training

Who cannot join

  • Wheelchair users would be excluded if he/she
  • cannot communicate or complete the study questionnaires in English
  • has a health condition or upcoming procedure that would prevent you from performing training activities (e.g., cancer treatment, surgery)
  • is currently receiving wheelchair skills training elsewhere
  • cannot use both arms to propel your wheelchair
  • Caregivers will be excluded if
  • he/she cannot communicate in English
  • he/she has a health condition or upcoming procedure that would prevent you from supervising training activities (e.g., cancer treatment, surgery)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • GF Strong Rehabilitation Centre

    Vancouver, British Columbia, V5Z 2G9

  • University of Manitoba

    Winnipeg, Manitoba, R3E 0T6

Other trials in Canada

About this study

Official title: Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): A Feasibility Study

Many older adults have difficulty walking. A wheelchair can improve their participation but older adults typically receive little wheelchair training. Structured training programs are effective but rely on multiple 1:1 sessions with a skilled clinician. EPIC WheelS combines 2 brief training sessions and a 4-week home training program delivered using a portable computer tablet and monitored by an expert trainer. This study investigates the feasibility and potential for using EPIC WheelS with older adult novice wheelchair users in Vancouver and Winnipeg, measuring the impact on wheelchair skill, safety and confidence compared to a control group receiving only cognitive training.

Hypotheses: The investigators expect that the feasibility outcomes will be sufficiently robust to support conducting a subsequent multi-site RCT. The investigators also expect the EPIC WheelS training program will have a significant treatment effect with improvement in wheelchair mobility, compared to a control group.

Read the detailed description

Many older adults rely on a manual wheelchair (MWC) for community mobility, but are not provided with the skills for independent and effective use of their wheelchair. Suboptimal use of the wheelchair results in substantial social costs such as reduced engagement in meaningful activity, social isolation, and higher caregiver burden. This is a poor use of financial resources, including the cost of wheelchair acquisition and requirements for attendant care. Access to skills training is constrained by the expense and limited availability of skilled therapists; demands of patient and/or clinician travel; and lack of training programs designed specifically for older adults.

Enhancing Participation In the Community by improving Wheelchair Skills (EPIC WheelS) is an individualized home-training program that optimizes learning for older adults while limiting the time demands of expert trainers. Using an affordable mainstream computer tablet device, EPIC WheelS provides a structured training program that can be customized for specific users needs. The tablet is mobile, for in-chair or tabletop use, in home and community locations. A touch screen operated audio-visual display features interactive training and practice activities as well as video-recording capability. Wireless Internet enables user-trainer communication and remote program monitoring and updating by the trainer. A monitored home program that is effective and efficient for older adults has the potential for application to other target groups, particularly those in rural and remote locations with limited access to rehabilitation.

PURPOSE: The purpose is to evaluate the feasibility and effect size estimate of a 1-month customized home training program (EPIC WheelS) for improving wheelchair mobility skills among novice older adult manual wheelchair users compared to usual care. Despite the pervasive use of wheelchairs as an intervention in rehabilitation, the evidence for training in effective wheelchair use is still underdeveloped. Structured training has demonstrated excellent potential, but the most effective and efficient means of providing that training remains unclear. Larger multi-site clinical trials are required to establish evidence to inform and direct clinical practice. The investigators propose that this 2-year feasibility trial is not only critical, but also prudent, prior to moving forward with an expensive large multi-site randomized controlled trial (RCT). Specifically the results of this study will address 1) feasibility outcomes (i.e., recruitment and retention; trainer and subject burden; safety; intervention administration and adherence; perceived benefit) and 2) clinical outcomes (i.e., effect size calculations for the primary and secondary measures). Although the principal intent is feasibility, the sample size calculation is based on the primary clinical outcome to provide a reasonable estimate of an effect size for planning the subsequent large scale RCT.

HYPOTHESES: The investigators expect that the feasibility outcomes will be sufficiently robust to support conducting a subsequent multi-site RCT. The investigators also expect the EPIC WheelS training program will have a significant treatment effect with improvement in wheelchair mobility, compared to a control group. The primary clinical endpoint will be wheelchair skill capacity, as measured by the Wheelchair Skills Test (WST). Secondary clinical outcomes will include wheelchair skill safety; confidence with wheelchair use; mobility; and user evaluation of performance in participation-oriented activities.

Being tested
EPIC WheelS Training Program
Keywords
rehabilitation, wheelchair, manual wheelchair, wheelchair users, older adults, cognitive computer games, home-based training, community mobility
Medical subject headings
Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPIC WheelS Training ProgramDevice

    Subjects will attend an initial assessment/training session and receive a customized home program from their Trainer, which is delivered by way of a portable, interactive computer tablet that can be used for practice in their home or other community venues. After 2 weeks of practice, subjects return for a second 1-hour training session. The Trainer updates their program and they continue practicing at home for another 2 weeks. Subjects will have a caregiver attend all training sessions and supervise their home training. Trainers monitor subject activity remotely and will contact subjects by telephone at the end of weeks 1 and 3 to promote program adherence. Participants in an extra wheeling sub-group will be instructed to perform additional, unstructured wheeling for 15 minutes, 5 days per week and document these on a simple calendar-style form provided.

Study groups in NCT01740635
Study groupRoleWhat they receive
EPIC WheelS Training ProgramExperimentalThe EPIC WheelS program includes a comprehensive, structured library of educational material and training activities, organized in a hierarchy from simple to complex. Experimental group subjects will attend 2 training sessions with an expert Trainer. The Trainer will individualize a structured home training program, delivered via a computer tablet, and subjects will train at home for 1 month.
Receives: Device: EPIC WheelS Training Program
Cognitive gamesNo interventionTo provide a comparable level of investigator attention, control group subjects will receive two 1-hour social visits. To control for Trainer bias, the experimental and control groups will have separate Trainers. During social visits, the Trainer will discuss subjects' current community activities and their experience using the wheelchair, and provide verbal information related to barriers encountered. Subjects will receive a computer tablet with cognitive stimulation games to account for activity and tablet device exposure. Participants in the extra wheeling sub-group will be instructed to perform additional, unstructured wheeling for 15 minutes, 5 days per week (total 75 minutes/week) and document these on a simple calendar-style form provided. To minimize attrition, control subjects will receive a DVD with a condensed MWC skills education program after the post-intervention data collection is complete.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wheelchair Skills Test (WST) - Capacity

    Wheelchair mobility skill capacity will be measured using the Wheelchair Skills Test 4.1 (WST). The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed. To optimize stability of the measure, increase precision, and control for a learning effect, the WST will be administered twice at baseline and a mean baseline score calculated. Standardized equipment required for the WST (e.g., 5 degree \& 10 degree ramps, gravel) is available at both test sites.

    Measured: 4 weeks

Secondary outcomes (11)
  1. Wheelchair Outcome Measure (WhOM)

    The rehabilitation literature strongly suggests that intervention outcomes should include not only externally defined measures, but also measures of user-identified activities of relevance and perceived satisfaction with performance. As part of the baseline data collection, the five most important activities identified with the WhOM will be used to customize the training program for experimental group subjects.

    Measured: Baseline, 4 weeks

  2. Wheelchair Use Confidence Scale for Manual Wheelchair Users (WheelCon-M 3.0)

    The WheelCon is a self-report questionnaire composed of 65 statements related to confidence using a wheelchair in activities and environments, each rated on a scale from 0 ("not confident") to 100 ("completely confident"), producing a total mean score of 0 - 100.

    Measured: Baseline, 4 weeks

  3. Life-Space Assessment (LSA)

    The LSA will capture the mobility habits of study subjects. It is a 20-item questionnaire that tracks the locations to which wheelchair users travel on a continuum of 5 environments from the home to outside of town. Subjects report on their movement in each life-space during the past 4 weeks, the frequency of travel, and whether assistance was required.

    Measured: Baseline, 4 weeks

  4. Health Utility Index 3

    The Health Utility Index 3 (HUI3) is a brief questionnaire that asks subjects about their health status, reflected in a single-score measure of health-related quality of life (HRQOL).

    Measured: Baseline, 4 weeks

  5. Wheeling While Talking Test

    The Walking While Talking test will be modified for use with a wheelchair and used to evaluate divided-attention during wheelchair propulsion; we will call this the Wheeling While Talking test.

    Measured: Baseline, 4 weeks

  6. Wheelchair Skills Test (WST) - Safety

    The WST also provides a total Skill Safety score (0-100%) reflecting the number of skills addressed in a safe manner, regardless of whether the skill is passed or not.

    Measured: Baseline, 4 weeks

  7. Participant retention rate of 80%

    Measured: Baseline, 4 weeks

  8. Training adherence (150 minutes/week) rate of 85%

    Measured: Baseline, 4 weeks

  9. No adverse events reported

    Measured: Baseline, 4 weeks

  10. Wheeling While Talking test

    Wheelchair mobility is a complex skill and prone to risk for tips, falls and potential injury, particularly with older adult users where motor and cognitive function may decline with age. The Wheeling While Talking test is a new divided-attention assessment for wheelchair users, currently undergoing reliability testing. Collecting data in this study will allow investigation of associations between performance and wheelchair skill, safety and other demographic factors, contributing to validation of this tool.

    Measured: Baseline, 4 weeks

  11. Data logger

    To capture level of activity while in the wheelchair, a data logger will be mounted on the drive wheel spokes of each participant's wheelchair. The data logger is a small, unobtrusive 'black box' that collects distance and speed via an accelerometer over a period of 6-10 days, depending upon battery life. Collecting this data will allow description and comparison of wheeling patterns and extent of activity among participants. Data loggers will be installed at the first training session and removed at the second training session, approximately 2 weeks later.

    Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740635
Sponsor's protocol ID
H12-02043
Status last verified
May 2018
First submitted
15 Nov 2012
Last updated
30 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Rushton PW, Miller WC, Mortenson WB, Garden J. Satisfaction with participation using a manual wheelchair among individuals with spinal cord injury. Spinal Cord. 2010 Sep;48(9):691-6. doi: 10.1038/sc.2009.197. Epub 2010 Feb 2.

    PubMed 20125106
  • Giesbrecht EM, Miller WC. Effect of an mHealth Wheelchair Skills Training Program for Older Adults: A Feasibility Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):2159-2166. doi: 10.1016/j.apmr.2019.06.010. Epub 2019 Jul 20.

    PubMed 31336101
  • Giesbrecht EM, Miller WC, Eng JJ, Mitchell IM, Woodgate RL, Goldsmith CH. Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial. Trials. 2013 Oct 24;14:350. doi: 10.1186/1745-6215-14-350.

    PubMed 24156396

Questions about this trial

What is this clinical trial studying?

A study testing EPIC WheelS Training Program in people with Difficulty Walking, run by University of British Columbia at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wheelchair Skills Test (WST) - Capacity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01740635, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.

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