Determining Levels of Function Associated With Permobil SmartDrive Manual Wheelchair Assist

Wheelchairs Clinical Trial

Official title:

Determining Levels of Enhanced Function Associated With the Permobil SmartDrive Manual Wheelchair Power Assist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973059
• Other study ID #: Pro00106859
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 4, 2022

Study information

• Verified date: October 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 4, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Wheelchairs

Intervention

Device:
• SmartDrive Summer
The SmartDrive is a power assist accessory for a manual wheelchair
• SmartDrive Winter
The SmartDrive is a power assist accessory for a manual wheelchair

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Permobil, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wheelchair Users Outcome Measure (WhOM) change is being assessed	Wheelchair Users Outcome Measure Range 0-100 high values indicate high level of satisfaction with wheelchair participation/activity	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.
Primary	Wheelchair User's Shoulder Pain Index (WUSPI) change is being assessed	Wheelchair Users' Pain Index Range 0 - 150 VAS high values indicate higher pain	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.