Determining Levels of Function Associated With Permobil SmartDrive Manual Wheelchair Assist

NCT04973059 | Completed

• 1 other identifier: Pro00106859
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Wheelchairs

Keywords

wheelchair; participation; accessibility; power assist; overuse injury

Outcome Measures

Primary Outcomes (1)

• 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.

Other Outcomes (1)

• Wheelchair Users Outcome Measure (WhOM) change is being assessed

  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.

Study Arms (4)

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.

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.

Device: SmartDrive Winter

Interventions

SmartDrive Summer DEVICE

The SmartDrive is a power assist accessory for a manual wheelchair

Summer Conditions with SmartDrive

SmartDrive Winter DEVICE

The SmartDrive is a power assist accessory for a manual wheelchair

Winter Conditions with SmartDrive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Permobil, Inc.: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, AB T6G 2R3, Canada

Location

Related Publications (1)

• 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.

  PMID: 40197107 DERIVED

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and Strains; Wounds and Injuries

Study Officials

• Martin Ferguson-Pell, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 22, 2021
• Study Start: September 1, 2021
• Primary Completion: April 15, 2022
• Study Completion: September 4, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-10

Locations

CA (1)