Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04973059
Brief 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.
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:
NCT04973059
Study Brief:
Protocol Section:
NCT04973059