Clinical trial NCT01740635: EPIC WheelS Feasibility Study
Official title: Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficulty Walking
Keywords: rehabilitation
wheelchair
manual wheelchair
wheelchair users
older adults
cognitive computer games
home-based training
community mobility
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

* 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

Exclusion Criteria:

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)

Primary outcomes:
measure: Wheelchair Skills Test (WST) - Capacity
timeFrame: 4 weeks
Secondary outcomes:
measure: Wheelchair Outcome Measure (WhOM)
timeFrame: Baseline, 4 weeks
measure: Wheelchair Use Confidence Scale for Manual Wheelchair Users (WheelCon-M 3.0)
timeFrame: Baseline, 4 weeks
measure: Life-Space Assessment (LSA)
timeFrame: Baseline, 4 weeks
measure: Health Utility Index 3
timeFrame: Baseline, 4 weeks
measure: Wheeling While Talking Test
timeFrame: Baseline, 4 weeks
measure: Wheelchair Skills Test (WST) - Safety
timeFrame: Baseline, 4 weeks
measure: Participant retention rate of 80%
timeFrame: Baseline, 4 weeks
measure: Training adherence (150 minutes/week) rate of 85%
timeFrame: Baseline, 4 weeks
measure: No adverse events reported
timeFrame: Baseline, 4 weeks
measure: Wheeling While Talking test
timeFrame: Baseline, 4 weeks
measure: Data logger
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of British Columbia
name: William C. Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.