search
Back to results

EPIC WheelS Feasibility Study

Primary Purpose

Difficulty Walking

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
EPIC WheelS Training Program
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Difficulty Walking focused on measuring rehabilitation, wheelchair, manual wheelchair, wheelchair users, older adults, cognitive computer games, home-based training, community mobility

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • GF Strong Rehabilitation Centre
  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EPIC WheelS Training Program

Cognitive games

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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.
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.
Participant retention rate of 80%
Training adherence (150 minutes/week) rate of 85%
No adverse events reported
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.
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.

Full Information

First Posted
November 15, 2012
Last Updated
May 25, 2018
Sponsor
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT01740635
Brief Title
EPIC WheelS Feasibility Study
Official Title
Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficulty Walking
Keywords
rehabilitation, wheelchair, manual wheelchair, wheelchair users, older adults, cognitive computer games, home-based training, community mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPIC WheelS Training Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive games
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EPIC WheelS Training Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wheelchair Skills Test (WST) - Capacity
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Wheelchair Outcome Measure (WhOM)
Description
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.
Time Frame
Baseline, 4 weeks
Title
Wheelchair Use Confidence Scale for Manual Wheelchair Users (WheelCon-M 3.0)
Description
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.
Time Frame
Baseline, 4 weeks
Title
Life-Space Assessment (LSA)
Description
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.
Time Frame
Baseline, 4 weeks
Title
Health Utility Index 3
Description
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).
Time Frame
Baseline, 4 weeks
Title
Wheeling While Talking Test
Description
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.
Time Frame
Baseline, 4 weeks
Title
Wheelchair Skills Test (WST) - Safety
Description
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.
Time Frame
Baseline, 4 weeks
Title
Participant retention rate of 80%
Time Frame
Baseline, 4 weeks
Title
Training adherence (150 minutes/week) rate of 85%
Time Frame
Baseline, 4 weeks
Title
No adverse events reported
Time Frame
Baseline, 4 weeks
Title
Wheeling While Talking test
Description
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.
Time Frame
Baseline, 4 weeks
Title
Data logger
Description
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.
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C. Miller, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
GF Strong Rehabilitation Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20125106
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.
Results Reference
background
PubMed Identifier
31336101
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.
Results Reference
derived
PubMed Identifier
24156396
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.
Results Reference
derived

Learn more about this trial

EPIC WheelS Feasibility Study

We'll reach out to this number within 24 hrs