Power WheelchairPhase 1CoPILOTNCT02320786
Collaborative Power Mobility Innovative Learning OpporTunity (CoPILOT) - A Pilot Study of a New Training Approach (Phase 1)
A Phase 1 study testing CoPILOT in people with Power Wheelchair and Mild Cognitive Impairment, run by University of British Columbia at 1 site in Canada.
Trial summary
Losing the ability to walk can lead to fewer opportunities to socialize with friends and family and participate in the community. When this happens, powered wheelchairs can provide access to homes and communities, contributing to health and well-being. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Power Wheelchair, Mild Cognitive Impairment, Spinal Cord Injuries
- What is being tested?
- CoPILOT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Dec 2020
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
The following criteria MUST be met in order for the participant to be eligible for the study:
- Have sustained a spinal cord injury; and
- Have mild to moderate cognitive impairment (MMSE 18-26); and
- Be new to powered wheelchairs (no full time driving experience for 3 weeks or more within the past five years) or previously denied a powered wheelchair (due to cognitive impairments impacting ability to learn or inability to learn the required skills); and
- Be physically able to operate a powered wheelchair joystick.
Participants will not be eligible for the study if ANY of the following criteria are met:
- Have a visual or hearing impairment which may compromise training safety; OR
- Do not understand English well enough to complete assessments and/or training.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Losing the ability to walk can lead to fewer opportunities to socialize with friends and family and participate in the community. When this happens, powered wheelchairs can provide access to homes and communities, contributing to health and well-being. Training by a qualified occupational therapist allows an individual to use a powered wheelchair safely and effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time consuming for people with cognitive and physical challenges. In this study, we will ask participants with cognitive impairments to complete training with an occupational therapist using either a shared control wheelchair or training methods according to the standard of care. We believe shared control training, entitled Collaborative Powered mobility Innovative Learning OpporTunity (CoPILOT) will enhance driving skill while maximizing safety learning. CoPILOT has the potential to enable people to participate more in their day to day lives and regain mobility independence.
Read the detailed description
Background: Powered wheelchairs can improve participation in daily life, increase quality of life, and add 'life to years' for individuals with SCI. Cognitive limitations, associated with advanced age at the time of a spinal cord injury or comorbid traumatic brain injury, impair learning and may prevent an individual from acquiring or maintaining skills necessary to drive a powered mobility device. Standard power wheelchair training, limited by time, equipment and budget constraints, may not meet the learning needs of individuals with cognitive impairment, preventing an individual from obtaining use of a powered wheelchair, impacting independence and quality of life. The total system cost of procuring a power wheelchair can range from $10,000 - $30,000; suboptimal use resulting from inadequate training is a poor use of resources and comes at a substantial social price. The Collaborative Power mobility Innovative Learning OpporTunity (CoPILOT) is a training approach utilizing shared control wheelchair technology and allows a therapist to provide an error-free learning experience for individuals in their own environments, while maintaining safety of the user and the individuals around them. Using shared control technology, the wheelchair user remains in control of the wheelchair while learning to drive, except in cases where the trainer overrides the control (using a remote controlled interface) to maintain safety and provide targeted learning opportunities.
Purpose and Objectives: Our purpose is to obtain pilot data for a larger randomized control trial of a shared control power wheelchair training program (CoPILOT) for improving power wheelchair mobility skills among novice power wheelchair users with comorbid cognitive impairment compared to standard of care. Collection of pilot data is necessary prior to moving forward with a larger randomized controlled trial (RCT).
Hypotheses: We expect the intervention protocol will be feasible for a larger randomized control trial. Compared to the standard of care group, we expect the CoPILOT group will experience significant improvement in power wheelchair skill capacity. We also expect the CoPILOT group will experience improvements in wheelchair skill safety, confidence, capacity for divided attention tasks, and health related quality of life, compared to the standard of care participants.
Methods: Our feasibility study will use an evaluator blind parallel RCT. New power wheelchair users with mild to moderate cognitive impairment will be recruited from the GF Strong or Vancouver General Hospital Spinal Cord Injury patient population. Participants will be randomly assigned to a CoPILOT (shared control training) group or standard of care group. All training will be completed by qualified occupational therapist trainers. Participants in both groups will receive 12 hours of training in a standard powered wheelchair; however, the CoPILOT groups will use remote control technology we have developed. Post-Treatment Qualitative Interviews will be conducted. Questions will be related to protocol administration and use of the CoPILOT approach and shared control technology, including necessary modifications.
- Being tested
- CoPILOT
- Keywords
- Power mobility, Wheelchair skills training, Spinal Cord Injury
- Medical subject headings
- Cognitive Dysfunction, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoPILOTBehavioural
Participants in both groups will receive twelve hours of training in a standard powered wheelchair however the CoPILOT groups will use remote control technology we have developed. The technology provides the trainer with remote control of wheelchair speed and direction allowing the trainer to override the participant's actions as needed to ensure safe error-free shared controlled wheelchair training. The CoPILOT approach will accommodate varied learning needs, as per adult learning principles, while decreasing trainer input until the participant can complete tasks independently.
| Study group | Role | What they receive |
|---|---|---|
| CoPILOT | Experimental | Experimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 12 hours total training time (one hour, four times per week for three weeks). Receives: Behavioral: CoPILOT |
| Standard of Care | No intervention | Standard of care participants will receive training according to the standard of care in rehabilitation facilities in the Vancouver area in a standard powered wheelchair, consisting of 12 hour protocols in a standard power wheelchair (one hour, four times per week for three weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Power-mobility Indoor Driving Assessment (PIDA)
The PIDA covers specific tasks required for functional indoor driving, which are specific to the environment (i.e. accessing the bed from the right and left, and approaching the closet and dresser in the bedroom). The PIDA has been evaluated for content and face validity, has good inter-rater (ICC 0.87) and fair intra-rater (ICC 0.67) reliability.55. We aim to explore the potential usefulness of this outcome measure for this population, in this environment, for inclusion in future clinical trials.
Measured: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Secondary outcomes (6)
Change in Wheelchair Skills Test Questionnaire (WST-P-Q)
The WST-P-Q is a standardized subjective evaluation of the capacity, performance, and confidence for 30 powered wheelchair skills. Total percent scores (0-100%) are calculated for both capacity, performance, and confidence. The WST was selected as a secondary measure because it is a standardized tool for evaluating wheelchair capacity, the primary construct of interest.
Measured: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Change in Wheelchair-use Confidence Scale (WheelCon-P )
This measurement for power wheelchair users is a 59-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 (pre-randomization), 5 weeks (immediate post-intervention)
Change in 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 (pre-randomization), 5 weeks (immediate post-intervention)
Change in The Wheelchair Outcome Measure (WhOM)
The WhOM assess the individual's wheelchair related goals, the importance of those goals, and the satisfaction in their ability to complete those tasks. This will be used to assess goal attainment (performance and satisfaction) following training.
Measured: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
The Wheeling While Talking Test
The Wheeling While Talking Test assesses the individual's ability to complete wheeling tasks under divided attention conditions. This test is being evaluated for use in powered wheelchair studies.
Measured: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Sensory data
A variety of anonymized sensor data will be collected (not linked to participant files). Data will be used to characterize situations which were deemed unsafe by the trainer, and to analyse steering and intervention behaviours. The following sensor data will be collected from the wheelchair control system (computerized): Joystick movements and button presses (both trainer and participant) and wheelchair movements (odometry). The following sensors data will be collected from sensors attached to the wheelchair: distance to obstacles (laser rangefinders), environmental context (outward looking RGBD cameras), wheelchair movements (accelerometer, gyroscope, compass).
Measured: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startOct 2016
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Power WheelchairStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Networks of Centres of Excellence of Canada, Alzheimer Society of Canada, Canadian Institutes of Health Research (CIHR), Promobilia Foundation, Rick Hansen Foundation
- 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
- NCT02320786
- Sponsor's protocol ID
- H14-01702
- Acronym
- CoPILOT
- Status last verified
- Jul 2024
- First submitted
- 10 Dec 2014
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith EM, Tregobov N, Miller WC. A feasibility study of a shared control powered wheelchair training program for individuals with spinal cord injury. Spinal Cord. 2026 Jan;64(1):40-45. doi: 10.1038/s41393-025-01134-5. Epub 2025 Nov 12.
PubMed 41225155
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Power Mobility Innovative Learning OpporTunity (CoPILOT) - A Pilot Study of a New Training Approach (Phase 1)
- ClinicalTrials.gov ID
- NCT02320786
- Acronym / sponsor ID
- CoPILOT / H14-01702
- Keywords
- Power mobility, Wheelchair skills training, Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Networks of Centres of Excellence of Canada, Alzheimer Society of Canada, Canadian Institutes of Health Research (CIHR), Promobilia Foundation, Rick Hansen Foundation
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 19 Dec 2014 (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.
Losing the ability to walk can lead to fewer opportunities to socialize with friends and family and participate in the community. When this happens, powered wheelchairs can provide access to homes and communities, contributing to health and well-being. Training by a qualified occupational therapist allows an individual to use a powered wheelchair safely and effectively. Learning to drive a powered wheelchair can be difficult, frustrating and time consuming for people with cognitive and physical challenges. In this study, we will ask participants with cognitive impairments to complete training with an occupational therapist using either a shared control wheelchair or training methods according to the standard of care. We believe shared control training, entitled Collaborative Powered mobility Innovative Learning OpporTunity (CoPILOT) will enhance driving skill while maximizing safety learning. CoPILOT has the potential to enable people to participate more in their day to day lives and regain mobility independence.
Detailed description
Background: Powered wheelchairs can improve participation in daily life, increase quality of life, and add 'life to years' for individuals with SCI. Cognitive limitations, associated with advanced age at the time of a spinal cord injury or comorbid traumatic brain injury, impair learning and may prevent an individual from acquiring or maintaining skills necessary to drive a powered mobility device. Standard power wheelchair training, limited by time, equipment and budget constraints, may not meet the learning needs of individuals with cognitive impairment, preventing an individual from obtaining use of a powered wheelchair, impacting independence and quality of life. The total system cost of procuring a power wheelchair can range from $10,000 - $30,000; suboptimal use resulting from inadequate training is a poor use of resources and comes at a substantial social price. The Collaborative Power mobility Innovative Learning OpporTunity (CoPILOT) is a training approach utilizing shared control wheelchair technology and allows a therapist to provide an error-free learning experience for individuals in their own environments, while maintaining safety of the user and the individuals around them. Using shared control technology, the wheelchair user remains in control of the wheelchair while learning to drive, except in cases where the trainer overrides the control (using a remote controlled interface) to maintain safety and provide targeted learning opportunities.
Purpose and Objectives: Our purpose is to obtain pilot data for a larger randomized control trial of a shared control power wheelchair training program (CoPILOT) for improving power wheelchair mobility skills among novice power wheelchair users with comorbid cognitive impairment compared to standard of care. Collection of pilot data is necessary prior to moving forward with a larger randomized controlled trial (RCT).
Hypotheses: We expect the intervention protocol will be feasible for a larger randomized control trial. Compared to the standard of care group, we expect the CoPILOT group will experience significant improvement in power wheelchair skill capacity. We also expect the CoPILOT group will experience improvements in wheelchair skill safety, confidence, capacity for divided attention tasks, and health related quality of life, compared to the standard of care participants.
Methods: Our feasibility study will use an evaluator blind parallel RCT. New power wheelchair users with mild to moderate cognitive impairment will be recruited from the GF Strong or Vancouver General Hospital Spinal Cord Injury patient population. Participants will be randomly assigned to a CoPILOT (shared control training) group or standard of care group. All training will be completed by qualified occupational therapist trainers. Participants in both groups will receive 12 hours of training in a standard powered wheelchair; however, the CoPILOT groups will use remote control technology we have developed. Post-Treatment Qualitative Interviews will be conducted. Questions will be related to protocol administration and use of the CoPILOT approach and shared control technology, including necessary modifications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoPILOT | Experimental | Behavioral: CoPILOTExperimental group participants will receive structured training in a standard powered wheelchair using the CoPILOT shared control wheelchair technology consisting of 12 hours total training time (one hour, four times per week for three weeks). |
| Standard of Care | No intervention | –Standard of care participants will receive training according to the standard of care in rehabilitation facilities in the Vancouver area in a standard powered wheelchair, consisting of 12 hour protocols in a standard power wheelchair (one hour, four times per week for three weeks). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CoPILOTParticipants in both groups will receive twelve hours of training in a standard powered wheelchair however the CoPILOT groups will use remote control technology we have developed. The technology provides the trainer with remote control of wheelchair speed and direction allowing the trainer to override the participant's actions as needed to ensure safe error-free shared controlled wheelchair training. The CoPILOT approach will accommodate varied learning needs, as per adult learning principles, while decreasing trainer input until the participant can complete tasks independently. | Behavioural | CoPILOT |
Primary outcome
Change in Power-mobility Indoor Driving Assessment (PIDA)
Time frame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
The PIDA covers specific tasks required for functional indoor driving, which are specific to the environment (i.e. accessing the bed from the right and left, and approaching the closet and dresser in the bedroom). The PIDA has been evaluated for content and face validity, has good inter-rater (ICC 0.87) and fair intra-rater (ICC 0.67) reliability.55. We aim to explore the potential usefulness of this outcome measure for this population, in this environment, for inclusion in future clinical trials.
6 secondary outcomes
Change in Wheelchair Skills Test Questionnaire (WST-P-Q)
Time frame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Change in Wheelchair-use Confidence Scale (WheelCon-P )
Time frame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Change in Health Utility Index Mark 3 (HUI3)
Time frame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Change in The Wheelchair Outcome Measure (WhOM)
Time frame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
The Wheeling While Talking Test
Time frame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
Sensory data
Time frame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)
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 23 Jul 2024.
- Derived from this study: PubMed 41225155Smith EM, Tregobov N, Miller WC. A feasibility study of a shared control powered wheelchair training program for individuals with spinal cord injury. Spinal Cord. 2026 Jan;64(1):40-45. doi: 10.1038/s41393-025-01134-5. Epub 2025 Nov 12.
Related trials for Power Wheelchair
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Active, not recruiting
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
Cerebral Palsy, Spinal Muscular Atrophy
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 Phase 1 study testing CoPILOT in people with Power Wheelchair and Mild Cognitive Impairment, 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?
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 23 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.
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?
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?
Change in Power-mobility Indoor Driving Assessment (PIDA) (time frame: Baseline (pre-randomization), 5 weeks (immediate post-intervention)). 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 NCT02320786, 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 23 Jul 2024.