WheelchairsNCT04973059
Determining Levels of Function Associated With Permobil SmartDrive Manual Wheelchair Assist
A study testing SmartDrive Summer and SmartDrive Winter in people with Wheelchairs, run by University of Alberta at 1 site in Canada.
Trial summary
This study will determine whether a power assist accessory for manual wheelchairs increases participation in community activities. This study will determine whether the power assist device (SmartDrive) is effective by increase participating in both winter and summer conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wheelchairs
- What is being tested?
- SmartDrive Summer and SmartDrive Winter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 4 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active wheelchair user using a wheelchair as their primary means of mobility (at least 4 hours each day)
- Capable of giving signed informed consent which includes compliance with the requirements listed in the informed consent form (ICF) and in this protocol
- 18 years of age inclusive, at the time of signing the informed consent.
- If the participant has a spinal cord injury Motor level C6-L3 Spinal Cord Injury, American Spinal Injury Association Impairment Scale (AIS) A-C since at least six months
- Full time manual wheelchair users, able to propel their own wheelchairs independently
- Eligible reason for SmartDrive prescription (Self-reported shoulder pain, and/or decreased physical endurance for propulsion, limiting user from activity)
Who cannot join
- Uncontrolled exercise-induced asthma
- Heart condition or high blood pressure
- Chest pain at rest, during physical activity, or during physical activity
- Severe visual impairment that requires an attendant or guide dog
- Cognitive impairment affecting the ability to operate the SmartDrive, indicated by participant's clinician
- Weigh more than 150 Kg due to the technical specification of the SmartDrive
Show all 10Show fewer
- Currently participating in another clinical study anticipated to affect the outcome or ability to compete this study
- Planned change from daily routines during the measurement periods, such as holiday, move, change jobs
- For any other reason not suitable for participation in the study indicated by participant's clinician
- Do not use a smart phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining Levels of Enhanced Function Associated With the Permobil SmartDrive Manual Wheelchair Power Assist
This study will determine whether a power assist accessory for manual wheelchairs increases participation in community activities. This study will determine whether the power assist device (SmartDrive) is effective by increase participating in both winter and summer conditions.
Read the detailed description
The University of Alberta, Faculty of Rehabilitation Medicine Rehabilitation Robotics Laboratory undertakes a wide range of research relating to wheelchair propulsion. They have developed a sensor (Redliner ) that measures levels of exertion associated with wheelchair ambulation during everyday activities. The device is linked to the user's cell phone and records a wide range of clinically relevant parameters continuously linking them to the GPS (global positioning system) coordinates of the wheelchair user. This device has significant advantages over more sophisticated wheelchair propulsion force measuring devices such as SmartWheel which are heavy and intended for clinic-based measurements. Redliner fits onto the wheels of any manual wheelchair and its low cost lends itself to clinical studies that are fully powered statistically.
Permobil have developed a product, SmartDrive, that can be retrofitted to a manual wheelchair to provide assistance in propelling the wheelchair. It is paired to PushTracker E2 which communicates with the SmartDrive to record parameters such as location, distance travelled, speed and provides a convenient way to control the SmartDrive which is located between the rear wheels of the wheelchair.
The cost of the SmartDrive at US$6,500 exceeds that of most publicly funded manual wheelchairs but is much less than most powered wheelchairs. For manual wheelchair users the SmartDrive is intended to reduce the risk of upper extremity overuse injuries and enables wheelchair users who are marginally functional for community ambulation to achieve their goals, without substantial investment and the collateral costs of transportation and home modifications that a powered wheelchair entails.
One of the challenges of the SmartDrive technology is that the data that has been collected so far is not benchmarked against the performance of wheelchair users prior to acquiring the power assist capability. The "value added" by the device to the user is therefore primarily anecdotal. With the objective of ensuring this technology is widely available, including through public and employer funded benefits, criteria to indicate the level of benefit achieved with SmartDrive are needed. These in turn could be translated into eligibility criteria to be used by both wheelchair users and funders. Redliner could then be used routinely to collect baseline data for wheelchair users wishing to obtain a SmartDrive to determine this eligibility.
This study will compare the benefits of the SmartDrive in the challenging winter conditions in Edmonton and then in the Spring when snow cover has melted. Many wheelchair users in Canada report social isolation due to winter conditions, particularly associated with snow covered sidewalks and streets and this study could demonstrate a particular benefit of the SmartDrive.
The proposed project will bring together our Redliner technology with the SmartDrive/Pushtracker E2 in a complimentary manner in a carefully designed clinical trial of active manual wheelchair users. The study design will be a longitudinal (1 week), repeated measures, cohort, intervention cross-over trial conducted in winter and non-winter conditions. The order of the intervention (SmartDrive use) will be randomized. Both the SmartDrive and Redliner will provide measures of community functioning.
- Conditions
- Wheelchairs
- Being tested
- SmartDrive Summer, SmartDrive Winter
- Keywords
- wheelchair, participation, accessibility, power assist, overuse injury
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartDrive SummerDevice
The SmartDrive is a power assist accessory for a manual wheelchair
SmartDrive WinterDevice
The SmartDrive is a power assist accessory for a manual wheelchair
| Study group | Role | What they receive |
|---|---|---|
| Summer Conditions with SmartDrive | Active comparator | This arm is with the participant using the SmartDrive during a week in the summer. The SmartDrive is a manual wheelchair accessory that provide power assistance to reduce the necessary level of propulsion force. The goal is to increase participation by reducing propulsion effort. Receives: Device: SmartDrive Summer |
| Summer Conditions activity measurement only | No intervention | This arm is with the participant using their wheelchair during a week in the summer no power assist. |
| Winter Conditions activity measurement only | No intervention | This arm is with the participant using their wheelchair during a week in the winter no power assist |
| Winter Conditions with SmartDrive | Active comparator | This arm is with the participant using the SmartDrive during a week in the winter. The SmartDrive is a manual wheelchair accessory that provide power assistance to reduce the necessary level of propulsion force. The goal is to increase participation by reducing propulsion effort. Receives: Device: SmartDrive Winter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair User's Shoulder Pain Index (WUSPI) change is being assessed
Wheelchair Users' Pain Index Range 0 - 150 VAS high values indicate higher pain
Measured: Arm 1: Applied after 7 days of Use. Arm 2: Applied after 7 days of Use. Arm 3: Applied after 7 days of Use. Arm 4: Applied after 7 days of Use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Sep 2021
- Primary completion15 Apr 2022
- Study completion4 Sep 2022
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 WheelchairsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is not evaluating a clinical intervention. There is no anticipated clinical benefit from this study. It is assessing whether use of the SmartDrive increases participation and decreases solution isolation. Secondarily it is will provide information about the levels of exertion needed in comparing wheelchair propulsion using SmartDrive and usual wheelchair propulsion. We intend to determine if SmartDrive improves participation in the winter when it is difficult to propel manual wheelchair on snow covered sidewalks and parking lots. Participants will be randomly assigned to using either the SmartDrive or not in the first week of monitoring in the summer. They will then switch to either the intervention (SmartDrive) or control (no SmarDrive) for the next week. This will then be repeated in the winter. Activity information will be collected using the SmartDrive sensor and another sensor that will measure a wide range of activity data including for the control arm of the study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Permobil, Inc.
- Responsible party
- Sponsor
- Investigators
- Martin Ferguson-Pell, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973059
- Sponsor's protocol ID
- Pro00106859
- Status last verified
- Oct 2022
- First submitted
- 16 Jun 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hopkins JE, Selby ET, Shandal RK, Martin N, Ferguson-Pell M, Armstrong E. The effects of the SmartDrive on fostering participatory opportunities for manual wheelchair users: a qualitative exploration. Disabil Rehabil Assist Technol. 2025 Oct;20(7):2500-2509. doi: 10.1080/17483107.2025.2488387. Epub 2025 Apr 8.
PubMed 40197107
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Levels of Enhanced Function Associated With the Permobil SmartDrive Manual Wheelchair Power Assist
- ClinicalTrials.gov ID
- NCT04973059
- Acronym / sponsor ID
- Pro00106859
- Conditions
- Wheelchairs
- Keywords
- wheelchair, participation, accessibility, power assist, overuse injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Permobil, Inc.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- 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.
This study will determine whether a power assist accessory for manual wheelchairs increases participation in community activities. This study will determine whether the power assist device (SmartDrive) is effective by increase participating in both winter and summer conditions.
Detailed description
The University of Alberta, Faculty of Rehabilitation Medicine Rehabilitation Robotics Laboratory undertakes a wide range of research relating to wheelchair propulsion. They have developed a sensor (Redliner ) that measures levels of exertion associated with wheelchair ambulation during everyday activities. The device is linked to the user's cell phone and records a wide range of clinically relevant parameters continuously linking them to the GPS (global positioning system) coordinates of the wheelchair user. This device has significant advantages over more sophisticated wheelchair propulsion force measuring devices such as SmartWheel which are heavy and intended for clinic-based measurements. Redliner fits onto the wheels of any manual wheelchair and its low cost lends itself to clinical studies that are fully powered statistically.
Permobil have developed a product, SmartDrive, that can be retrofitted to a manual wheelchair to provide assistance in propelling the wheelchair. It is paired to PushTracker E2 which communicates with the SmartDrive to record parameters such as location, distance travelled, speed and provides a convenient way to control the SmartDrive which is located between the rear wheels of the wheelchair.
The cost of the SmartDrive at US$6,500 exceeds that of most publicly funded manual wheelchairs but is much less than most powered wheelchairs. For manual wheelchair users the SmartDrive is intended to reduce the risk of upper extremity overuse injuries and enables wheelchair users who are marginally functional for community ambulation to achieve their goals, without substantial investment and the collateral costs of transportation and home modifications that a powered wheelchair entails.
One of the challenges of the SmartDrive technology is that the data that has been collected so far is not benchmarked against the performance of wheelchair users prior to acquiring the power assist capability. The "value added" by the device to the user is therefore primarily anecdotal. With the objective of ensuring this technology is widely available, including through public and employer funded benefits, criteria to indicate the level of benefit achieved with SmartDrive are needed. These in turn could be translated into eligibility criteria to be used by both wheelchair users and funders. Redliner could then be used routinely to collect baseline data for wheelchair users wishing to obtain a SmartDrive to determine this eligibility.
This study will compare the benefits of the SmartDrive in the challenging winter conditions in Edmonton and then in the Spring when snow cover has melted. Many wheelchair users in Canada report social isolation due to winter conditions, particularly associated with snow covered sidewalks and streets and this study could demonstrate a particular benefit of the SmartDrive.
The proposed project will bring together our Redliner technology with the SmartDrive/Pushtracker E2 in a complimentary manner in a carefully designed clinical trial of active manual wheelchair users. The study design will be a longitudinal (1 week), repeated measures, cohort, intervention cross-over trial conducted in winter and non-winter conditions. The order of the intervention (SmartDrive use) will be randomized. Both the SmartDrive and Redliner will provide measures of community functioning.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is not evaluating a clinical intervention. There is no anticipated clinical benefit from this study. It is assessing whether use of the SmartDrive increases participation and decreases solution isolation. Secondarily it is will provide information about the levels of exertion needed in comparing wheelchair propulsion using SmartDrive and usual wheelchair propulsion. We intend to determine if SmartDrive improves participation in the winter when it is difficult to propel manual wheelchair on snow covered sidewalks and parking lots. Participants will be randomly assigned to using either the SmartDrive or not in the first week of monitoring in the summer. They will then switch to either the intervention (SmartDrive) or control (no SmarDrive) for the next week. This will then be repeated in the winter. Activity information will be collected using the SmartDrive sensor and another sensor that will measure a wide range of activity data including for the control arm of the study.
| Arm | Type | Receives |
|---|---|---|
| Summer Conditions with SmartDrive | Active comparator | Device: SmartDrive SummerThis arm is with the participant using the SmartDrive during a week in the summer. The SmartDrive is a manual wheelchair accessory that provide power assistance to reduce the necessary level of propulsion force. The goal is to increase participation by reducing propulsion effort. |
| Summer Conditions activity measurement only | No intervention | –This arm is with the participant using their wheelchair during a week in the summer no power assist. |
| Winter Conditions activity measurement only | No intervention | –This arm is with the participant using their wheelchair during a week in the winter no power assist |
| Winter Conditions with SmartDrive | Active comparator | Device: SmartDrive WinterThis arm is with the participant using the SmartDrive during a week in the winter. The SmartDrive is a manual wheelchair accessory that provide power assistance to reduce the necessary level of propulsion force. The goal is to increase participation by reducing propulsion effort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Active wheelchair user using a wheelchair as their primary means of mobility (at least 4 hours each day)
- Capable of giving signed informed consent which includes compliance with the requirements listed in the informed consent form (ICF) and in this protocol
- 18 years of age inclusive, at the time of signing the informed consent.
- If the participant has a spinal cord injury Motor level C6-L3 Spinal Cord Injury, American Spinal Injury Association Impairment Scale (AIS) A-C since at least six months
- Full time manual wheelchair users, able to propel their own wheelchairs independently
Key exclusion criteria (10 listed)
- Uncontrolled exercise-induced asthma
- Heart condition or high blood pressure
- Chest pain at rest, during physical activity, or during physical activity
- Severe visual impairment that requires an attendant or guide dog
- Cognitive impairment affecting the ability to operate the SmartDrive, indicated by participant's clinician
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 |
|---|---|---|
| SmartDrive SummerThe SmartDrive is a power assist accessory for a manual wheelchair | Device | Summer Conditions with SmartDrive |
| SmartDrive WinterThe SmartDrive is a power assist accessory for a manual wheelchair | Device | Winter Conditions with SmartDrive |
Primary outcome
Wheelchair User's Shoulder Pain Index (WUSPI) change is being assessed
Time frame: Arm 1: Applied after 7 days of Use. Arm 2: Applied after 7 days of Use. Arm 3: Applied after 7 days of Use. Arm 4: Applied after 7 days of Use.
Wheelchair Users' Pain Index Range 0 - 150 VAS high values indicate higher pain
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 15 Nov 2022.
- Derived from this study: PubMed 40197107Hopkins JE, Selby ET, Shandal RK, Martin N, Ferguson-Pell M, Armstrong E. The effects of the SmartDrive on fostering participatory opportunities for manual wheelchair users: a qualitative exploration. Disabil Rehabil Assist Technol. 2025 Oct;20(7):2500-2509. doi: 10.1080/17483107.2025.2488387. Epub 2025 Apr 8.
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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.
Martin Ferguson-Pell, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartDrive Summer and SmartDrive Winter in people with Wheelchairs, run by University of Alberta 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 6 inclusion and 10 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 15 Nov 2022. 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 User's Shoulder Pain Index (WUSPI) change is being assessed (time frame: Arm 1: Applied after 7 days of Use. Arm 2: Applied after 7 days of Use. Arm 3: Applied after 7 days of Use. Arm 4: Applied after 7 days of Use.). 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 NCT04973059, 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 15 Nov 2022.