Older Adult Manual Wheelchair UsersPhase 1EPIC WheelSNCT01644292
Enhancing Participation In the Community by Improving Wheelchair Skills: Phase 2
A Phase 1 study testing EPIC WheelS in people with Older Adult Manual Wheelchair Users, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills home training program for older adults in preparation for a third phase feasibility study. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Older Adult Manual Wheelchair Users
- What is being tested?
- EPIC WheelS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Mar 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- at least 50 years old
- live in the community within metropolitan Winnipeg
- self-propel a MWC (Manual Wheelchair) at least 1 hour per day
- use their MWC for mobility outside of the home
- have used a MWC for less than 2 years
Who cannot join
- cannot communicate and complete study questionnaires in English
- anticipate a health condition that contraindicates wheelchair training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): Phase 2
The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills home training program for older adults in preparation for a third phase feasibility study.
Read the detailed description
Many older adults rely on a manual wheelchair for community mobility but are not provided with skills for independent and effective use. Suboptimal or disuse of the wheelchair results in substantial social costs such as reduced engagement in meaningful activity, social isolation, and higher caregiver burden. This represents a poor use of financial resources, including the cost of wheelchair acquisition and demands for attendant care. Access to skills training is constrained by the cost and limited availability of skilled therapists, the demands of patient and clinician travel, and lack of programs designed specifically for the needs of 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 demands on expert clinician trainers. It is delivered using a portable computer tablet that allows interactive learning, customized updating, and communication with an expert trainer. A monitored, home program that is effective and efficient for older adults has potential application for other target groups as well, particularly those with limited access to rehabilitation services in rural and remote locations.
- Conditions
- Older Adult Manual Wheelchair Users
- Being tested
- EPIC WheelS
- Keywords
- Mobility Impairment, Manual Wheelchair, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIC WheelSOther
EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
| Study group | Role | What they receive |
|---|---|---|
| EPIC Wheels Training Intervention | Experimental | EPIC Wheels skills training program Receives: Other: EPIC WheelS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score
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.
Measured: Baseline and follow-up (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older Adult Manual Wheelchair UsersStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ed M Giesbrecht, PhD (Cand.), Principal investigator, University of ManitobaWilliam C Miller, PhD, Principal investigator, University of British ColumbiaJanice Eng, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644292
- Sponsor's protocol ID
- H2012:069
- Acronym
- EPIC WheelS
- Status last verified
- Jan 2014
- First submitted
- 13 Jul 2012
- Last updated
- 30 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Giesbrecht EM, Miller WC, Jin BT, Mitchell IM, Eng JJ. Rehab on Wheels: A Pilot Study of Tablet-Based Wheelchair Training for Older Adults. JMIR Rehabil Assist Technol. 2015 Apr 30;2(1):e3. doi: 10.2196/rehab.4274.
PubMed 28582240
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): Phase 2
- ClinicalTrials.gov ID
- NCT01644292
- Acronym / sponsor ID
- EPIC WheelS / H2012:069
- Conditions
- Older Adult Manual Wheelchair Users
- Keywords
- Mobility Impairment, Manual Wheelchair, Older Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills home training program for older adults in preparation for a third phase feasibility study.
Detailed description
Many older adults rely on a manual wheelchair for community mobility but are not provided with skills for independent and effective use. Suboptimal or disuse of the wheelchair results in substantial social costs such as reduced engagement in meaningful activity, social isolation, and higher caregiver burden. This represents a poor use of financial resources, including the cost of wheelchair acquisition and demands for attendant care. Access to skills training is constrained by the cost and limited availability of skilled therapists, the demands of patient and clinician travel, and lack of programs designed specifically for the needs of 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 demands on expert clinician trainers. It is delivered using a portable computer tablet that allows interactive learning, customized updating, and communication with an expert trainer. A monitored, home program that is effective and efficient for older adults has potential application for other target groups as well, particularly those with limited access to rehabilitation services in rural and remote locations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPIC Wheels Training Intervention | Experimental | Other: EPIC WheelSEPIC Wheels skills training program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 50 years old
- live in the community within metropolitan Winnipeg
- self-propel a MWC (Manual Wheelchair) at least 1 hour per day
- use their MWC for mobility outside of the home
- have used a MWC for less than 2 years
Key exclusion criteria (2 listed)
- cannot communicate and complete study questionnaires in English
- anticipate a health condition that contraindicates wheelchair training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPIC WheelSEPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment. | Other | EPIC Wheels Training Intervention |
Primary outcome
Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score
Time frame: Baseline and follow-up (1 month)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28582240Giesbrecht EM, Miller WC, Jin BT, Mitchell IM, Eng JJ. Rehab on Wheels: A Pilot Study of Tablet-Based Wheelchair Training for Older Adults. JMIR Rehabil Assist Technol. 2015 Apr 30;2(1):e3. doi: 10.2196/rehab.4274.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed M Giesbrecht, PhD (Cand.) principal investigator
University of Manitoba
William C Miller, PhD principal investigator
University of British Columbia
Janice Eng, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPIC WheelS in people with Older Adult Manual Wheelchair Users, run by University of Manitoba at 1 site 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 5 inclusion and 2 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score (time frame: Baseline and follow-up (1 month)). 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 NCT01644292, which also lists 1 linked publication.
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 Nov 2023.