Difficulty Walking Clinical Trial
Official title:
Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): A Feasibility Study
NCT number | NCT01740635 |
Other study ID # | H12-02043 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | May 2016 |
Verified date | May 2018 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | May 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Canada | GF Strong Rehabilitation Centre | Vancouver | British Columbia |
Canada | University of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Baseline, 4 weeks | |
Secondary | 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. | Baseline, 4 weeks | |
Secondary | 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. | Baseline, 4 weeks | |
Secondary | 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). | Baseline, 4 weeks | |
Secondary | 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. | Baseline, 4 weeks | |
Secondary | 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. | Baseline, 4 weeks | |
Secondary | Participant retention rate of 80% | Baseline, 4 weeks | ||
Secondary | Training adherence (150 minutes/week) rate of 85% | Baseline, 4 weeks | ||
Secondary | No adverse events reported | Baseline, 4 weeks | ||
Secondary | 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. | Baseline, 4 weeks | |
Secondary | 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. | Baseline, 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01774201 -
Respiratory Function and Walking Capacity in Multiple Sclerosis
|
N/A | |
Completed |
NCT01844375 -
A Trial of Preoperative CHO Drinks on Postoperative Walking Capacity in Colorectal Surgery
|
N/A | |
Completed |
NCT02567227 -
Cognitive Remediation to Improve Mobility in Sedentary Seniors
|
N/A | |
Completed |
NCT01807273 -
Time Up and go in Hemiplegic Patients
|
N/A | |
Completed |
NCT02484781 -
Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip Arthroplasty, an Exploratory Study
|
N/A | |
Recruiting |
NCT05152069 -
Spatio-temporal Parameters of Walking in Patients Hospitalized in Acute Geriatrics
|
||
Completed |
NCT01180738 -
Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
|
N/A |