Self-efficacyNCT01838135
WheelSeeU Feasibility Study
A study testing WheelSeeU Training Program in people with Self-efficacy and Wheelchair Mobility, run by University of British Columbia at 1 site in Canada.
Trial summary
Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to determine if: 1.WheelSeeU is feasible to administer; 2. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Self-efficacy, Wheelchair Mobility
- What is being tested?
- WheelSeeU Training Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years of age or older
- live in the community
- self-propel a manual wheelchair at least 1 hour/day
- have wheelchair mobility goals
- are cognitively able to engage in the program (Modified Mini-mental Status Exam score of ≥ 24).
Who cannot join
- cannot communicate and complete study questionnaires in English
- anticipate a health condition or procedure that contraindicates training (e.g., surgery scheduled which would impair physical activity)
- have a degenerative condition that is expected to progress quickly (e.g., Amyotrophic lateral sclerosis (ALS))
- are concurrently or are planning to receive wheelchair mobility training during the period of the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Wheelchair Self-efficacy Enhanced Training Program to Improve Wheelchair Use in Older Adults
Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use, confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in older adults compared to group-based information sessions; and 3. the study design is appropriate. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.
Read the detailed description
This study will use a two-site (Vancouver and Quebec City), single blinded (Tester) RCT to compare differences in older adults' wheelchair skill with WheelSeeU versus group-based information sessions. Subjects will be randomly assigned to the experimental group (WheelSeeU) or a control group (information sessions) using a 1:1 allocation ratio between groups. To support balance between groups and blinding of assignment, a central computerized randomization process will be designed by our team statistician, with an undisclosed block size and stratified by site (Vancouver n = 20 [+4 for 20% dropout]; Quebec City n = 20 +4 ). Once subjects are enrolled, the Tester will collect baseline data and enter them into a secure database. The Site Coordinator will contact Dr. Goldsmith via telephone or email and obtain group assignment within 48 hours. Subject contact information will be forwarded to the appropriate group Trainer to arrange for an initial training session or peer support session. To address bias, subjects will be instructed not to discuss their program and the Testers (1 per site) will be blinded to group allocation. Follow-up testing will occur at immediately and 6 months post-intervention.
To mask the participants from the study objectives, participants in both the intervention and control groups will be told that the intervention is designed to improve wheelchair use. The findings from the study will be summarized and mailed to each participant upon study completion.
WheelSeeU and the control group will be held at Blusson Spinal Cord Centre, GF Strong or in the community depending on participant preference.
- Conditions
- Self-efficacy, Wheelchair Mobility
- Being tested
- WheelSeeU Training Program
- Keywords
- wheelchair, manual wheelchair, rehabilitation, self-efficacy, older adults, feasibility, intervention, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WheelSeeU Training ProgramDevice
WheelSeeU sessions will be administered by a peer-trainer (older adult wheelchair user), who will be trained in a 2-day workshop to use social cognitive approaches (i.e. facilitating successful performance of wheelchair skills, learning through observation of peers, positive verbal reinforcement from peers and family members, and re-interpretation of physiological symptoms) to foster the improvement of self-efficacy for wheelchair use. Each WheelSeeU session will be tailored to the individual goals of participants, which will be identified during the start of each session.
| Study group | Role | What they receive |
|---|---|---|
| Group-based information sessions | No intervention | Control group subjects will take part in 6 x 1.5 hour sessions of group-based information sessions facilitated by a trained instructor, consisting of topics on general wheelchair use, transportation, pain and fatigue management, nutrition, and internet resources. The instructor will be trained to not provide any training on wheelchair skills, and will be instructed to divert any wheelchair skills related questions. |
| WheelSeeU Training Program | Experimental | Experimental group subjects will attend 6 x 1.5 hour training sessions (1-2 sessions/week) with a peer-Trainer. The peer-Trainer will facilitate WheelSeeU sessions and will lead participants through practice of wheelchair use goals. Receives: Device: WheelSeeU Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair Skills Test Version 4.1 (WST) Change
Wheelchair Skills Test Version 4.1 (WST) for manual wheelchair users is a standardized objective evaluation of the execution of 32 manual wheelchair skills (pass/fail) and the safety of skill execution (safe/unsafe). Total percent scores (0-100%) are calculated for both skill execution and safety. The WST was selected as the primary measure because it is a standardized tool for evaluating wheelchair capacity, the primary construct of interest.
Measured: Baseline, 6 weeks, 6 month follow-up
Secondary outcomes (6)
Wheelchair-use Confidence Scale (WheelCon) Version 3.0
Wheelchair-use Confidence Scale (WheelCon) Version 3.0 for manual wheelchair users is a 65-item self-report scale (0-100) with documented reliability and validity. Responses indicate current level of perceived confidence (%) to navigate the physical environment in a wheelchair, perform activities in a wheelchair, problem solve, advocate for specific needs, and manage social situations and emotions. The WheelCon was selected as a secondary outcome measure because confidence for using a wheelchair has been shown to influence wheelchair skills capacity.
Measured: Baseline, 6 weeks, 6 month follow-up
Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q)
Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q) for manual wheelchair users is a standardized subjective evaluation of perceived ability to execute 32 manual wheelchair skills (pass/fail). Total percent scores (0-100%) are calculated for wheelchair performance, based on whether or not the individual has successfully accomplished the skill in the past month. The WST-Q was selected as a secondary measure because it measures wheelchair skills performance, which may influence or be influenced by confidence using a wheelchair.
Measured: Baseline, 6 weeks, 6 month follow-up
Life-Space Assessment (LSA)
Life-Space Assessment (LSA) is a 20-item questionnaire that tracks the mobility habits of wheelchair users in a continuum of environmental contexts (home; around the home; in the neighbourhood; in town; and outside of town). Participants report on their attainment of each life-space during the past 4 weeks, the frequency of attainment, and whether assistance was required. The LSA was selected as an outcome measure because it provides information about an individual's mobility habits.
Measured: Baseline, 6 weeks, 6 month follow-up
Wheelchair Outcome Measure (WhOM)
The Wheelchair Outcome Measure (WhOM) is a client-specific measurement tool that identifies satisfaction with participation in desired activities for wheelchair users. Rates of perceived 'importance' of the goal (0-10) and 'satisfaction' with current performance of this activity (0-10) will be obtained. Scoring is calculated by multiplying 'importance' by 'satisfaction'. The WhOM was selected to obtain some information about participation goals of manual wheelchair users and to explore whether a wheelchair training intervention could influence perceived satisfaction with participation.
Measured: Baseline, 6 weeks, 6 month follow-up
Late Life Function and Disability Instrument (LLFDI)
Late Life Function and Disability Instrument (LLFDI) is comprised of a 16-item disability component and a 40-item function component, which includes 8 items specific for individuals who use assistive devices for mobility. Participants are first asked to identify the frequency of performing life tasks using a scale ranging from 1 (never) to 5 (very often) and then asked to identify the extent that they feel limited in performing specified tasks using a scale ranging from 1 (completely) to 5 (not at all). Item responses are summed to obtain two dimension scores and four domain scores in the disability component, and one overall function score and three domain scores in the function component. The scores are then converted into interval level scores ranging from 0 to 100.
Measured: Baseline, 6 weeks, 6 month follow-up
Health Utility Index Mark 3 (HUI3)
Health utility measurement is useful in performing cost-utility and cost-effectiveness analyses of new rehabilitation interventions. The 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)
Measured: Baseline, 6 weeks, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Self-efficacyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William C. Miller, University of British Columbia
- Investigators
- William C Miller, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838135
- Sponsor's protocol ID
- H13-00509
- Other IDs
- H13-00509
- Status last verified
- Jul 2024
- First submitted
- 28 Mar 2013
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller WC, Best KL, Eng JJ, Routhier F. Influence of Peer-led Wheelchair Training on Wheelchair Skills and Participation in Older Adults: Clinical Outcomes of a Randomized Controlled Feasibility Trial. Arch Phys Med Rehabil. 2019 Jun;100(6):1023-1031. doi: 10.1016/j.apmr.2018.10.018. Epub 2018 Nov 23.
PubMed 30476489Best KL, Miller WC, Routhier F, Eng JJ. Feasibility of the trial procedures for a randomized controlled trial of a community-based peer-led wheelchair training program for older adults. Pilot Feasibility Stud. 2017 Jul 17;4:18. doi: 10.1186/s40814-017-0158-3. eCollection 2018.
PubMed 28725451Best KL, Miller WC, Eng JJ, Routhier F, Goldsmith C. Randomized controlled trial protocol feasibility: The Wheelchair Self-Efficacy Enhanced for Use (WheelSeeU). Can J Occup Ther. 2014 Dec;81(5):308-19. doi: 10.1177/0008417414546743.
PubMed 25702375
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wheelchair Self-efficacy Enhanced Training Program to Improve Wheelchair Use in Older Adults
- ClinicalTrials.gov ID
- NCT01838135
- Acronym / sponsor ID
- H13-00509
- Conditions
- Self-efficacy, Wheelchair Mobility
- Keywords
- wheelchair, manual wheelchair, rehabilitation, self-efficacy, older adults, feasibility, intervention, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention for older adults (WheelSeeU) to determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use, confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in older adults compared to group-based information sessions; and 3. the study design is appropriate. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.
Detailed description
This study will use a two-site (Vancouver and Quebec City), single blinded (Tester) RCT to compare differences in older adults' wheelchair skill with WheelSeeU versus group-based information sessions. Subjects will be randomly assigned to the experimental group (WheelSeeU) or a control group (information sessions) using a 1:1 allocation ratio between groups. To support balance between groups and blinding of assignment, a central computerized randomization process will be designed by our team statistician, with an undisclosed block size and stratified by site (Vancouver n = 20 [+4 for 20% dropout]; Quebec City n = 20 +4 ). Once subjects are enrolled, the Tester will collect baseline data and enter them into a secure database. The Site Coordinator will contact Dr. Goldsmith via telephone or email and obtain group assignment within 48 hours. Subject contact information will be forwarded to the appropriate group Trainer to arrange for an initial training session or peer support session. To address bias, subjects will be instructed not to discuss their program and the Testers (1 per site) will be blinded to group allocation. Follow-up testing will occur at immediately and 6 months post-intervention.
To mask the participants from the study objectives, participants in both the intervention and control groups will be told that the intervention is designed to improve wheelchair use. The findings from the study will be summarized and mailed to each participant upon study completion.
WheelSeeU and the control group will be held at Blusson Spinal Cord Centre, GF Strong or in the community depending on participant preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-based information sessions | No intervention | –Control group subjects will take part in 6 x 1.5 hour sessions of group-based information sessions facilitated by a trained instructor, consisting of topics on general wheelchair use, transportation, pain and fatigue management, nutrition, and internet resources. The instructor will be trained to not provide any training on wheelchair skills, and will be instructed to divert any wheelchair skills related questions. |
| WheelSeeU Training Program | Experimental | Device: WheelSeeU Training ProgramExperimental group subjects will attend 6 x 1.5 hour training sessions (1-2 sessions/week) with a peer-Trainer. The peer-Trainer will facilitate WheelSeeU sessions and will lead participants through practice of wheelchair use goals. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 55 years of age or older
- live in the community
- self-propel a manual wheelchair at least 1 hour/day
- have wheelchair mobility goals
- are cognitively able to engage in the program (Modified Mini-mental Status Exam score of ≥ 24).
Key exclusion criteria (4 listed)
- cannot communicate and complete study questionnaires in English
- anticipate a health condition or procedure that contraindicates training (e.g., surgery scheduled which would impair physical activity)
- have a degenerative condition that is expected to progress quickly (e.g., Amyotrophic lateral sclerosis (ALS))
- are concurrently or are planning to receive wheelchair mobility training during the period of the study.
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 |
|---|---|---|
| WheelSeeU Training ProgramWheelSeeU sessions will be administered by a peer-trainer (older adult wheelchair user), who will be trained in a 2-day workshop to use social cognitive approaches (i.e. facilitating successful performance of wheelchair skills, learning through observation of peers, positive verbal reinforcement from peers and family members, and re-interpretation of physiological symptoms) to foster the improvement of self-efficacy for wheelchair use. Each WheelSeeU session will be tailored to the individual goals of participants, which will be identified during the start of each session. | Device | WheelSeeU Training Program |
Primary outcome
Wheelchair Skills Test Version 4.1 (WST) Change
Time frame: Baseline, 6 weeks, 6 month follow-up
Wheelchair Skills Test Version 4.1 (WST) for manual wheelchair users is a standardized objective evaluation of the execution of 32 manual wheelchair skills (pass/fail) and the safety of skill execution (safe/unsafe). Total percent scores (0-100%) are calculated for both skill execution and safety. The WST was selected as the primary measure because it is a standardized tool for evaluating wheelchair capacity, the primary construct of interest.
6 secondary outcomes
Wheelchair-use Confidence Scale (WheelCon) Version 3.0
Time frame: Baseline, 6 weeks, 6 month follow-up
Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q)
Time frame: Baseline, 6 weeks, 6 month follow-up
Life-Space Assessment (LSA)
Time frame: Baseline, 6 weeks, 6 month follow-up
Wheelchair Outcome Measure (WhOM)
Time frame: Baseline, 6 weeks, 6 month follow-up
Late Life Function and Disability Instrument (LLFDI)
Time frame: Baseline, 6 weeks, 6 month follow-up
Health Utility Index Mark 3 (HUI3)
Time frame: Baseline, 6 weeks, 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 30476489Miller WC, Best KL, Eng JJ, Routhier F. Influence of Peer-led Wheelchair Training on Wheelchair Skills and Participation in Older Adults: Clinical Outcomes of a Randomized Controlled Feasibility Trial. Arch Phys Med Rehabil. 2019 Jun;100(6):1023-1031. doi: 10.1016/j.apmr.2018.10.018. Epub 2018 Nov 23.
- Derived from this study: PubMed 28725451Best KL, Miller WC, Routhier F, Eng JJ. Feasibility of the trial procedures for a randomized controlled trial of a community-based peer-led wheelchair training program for older adults. Pilot Feasibility Stud. 2017 Jul 17;4:18. doi: 10.1186/s40814-017-0158-3. eCollection 2018.
- Derived from this study: PubMed 25702375Best KL, Miller WC, Eng JJ, Routhier F, Goldsmith C. Randomized controlled trial protocol feasibility: The Wheelchair Self-Efficacy Enhanced for Use (WheelSeeU). Can J Occup Ther. 2014 Dec;81(5):308-19. doi: 10.1177/0008417414546743.
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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.
William C Miller, 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 study testing WheelSeeU Training Program in people with Self-efficacy and Wheelchair Mobility, run by University of British Columbia 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 4 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 29 Jul 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wheelchair Skills Test Version 4.1 (WST) Change (time frame: Baseline, 6 weeks, 6 month follow-up). 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 NCT01838135, which also lists 3 linked publications.
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 29 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.