EPIC WheelS Feasibility Study

NCT01740635 | Completed

• 1 other identifier: H12-02043
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Difficulty Walking

Keywords

rehabilitation; wheelchair; manual wheelchair; wheelchair users; older adults; cognitive computer games; home-based training; community mobility

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (11)

• Wheelchair Outcome Measure (WhOM)

  Baseline, 4 weeks

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

  Baseline, 4 weeks

• Life-Space Assessment (LSA)

  Baseline, 4 weeks

• Health Utility Index 3

  Baseline, 4 weeks

• Wheeling While Talking Test

  Baseline, 4 weeks

Study Arms (2)

EPIC WheelS Training Program

EXPERIMENTAL

The 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.

Device: EPIC WheelS Training Program

Cognitive games

NO INTERVENTION

To 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.

Interventions

EPIC WheelS Training Program DEVICE

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.

EPIC WheelS Training Program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

Related Publications (3)

• 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.

  PMID: 20125106 BACKGROUND

• 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.

  PMID: 31336101 DERIVED

• 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.

  PMID: 24156396 DERIVED

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William C. Miller, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: December 4, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

CA (2)