NCT04241003

Effects of the SmartDrive on Mobility, Activity and Shoulder Pain Among People With SCI Using Manual Wheelchairs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Permobil, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study of manual wheelchair users with spinal cord injury (SCI). The users will be their own controls. The primary purpose of the study is to evaluate the ability of the power assist device SmartDrive to increase the ability to be mobile.

Detailed description

The hypothesis of the study is that the SmartDrive will enable the user to be more active, both in commuting longer distances with less strokes needed, and managing single difficulties stopping them from activity. The two assessments selected, distance travelled and the daily diary, should directly reflect the impact of the SmartDrive. In addition, the the International Spinal Cord Society (ISCoS) pain data set, Wheelchair User's Shoulder Pain Index (WUSPI) and Wheelchair Outcome Measure (WhOM) will be used. In WhOM, the participants will state some activities they perform in their wheelchair that are important to them, and how satisfied they are with their current level of performance of that activity. After the intervention period the satisfaction is reassessed. This will enable to capture the effect SmartDrive usage has on the participant's daily life (beyond distance commuted and pain level). After enrollment, the participants will be followed for two weeks using their wheelchair without SmartDrive. After attaching the SmartDrive, they will have three weeks to get into a use of the device on a regular basis in their everyday life, and then follows two consecutive weeks of study intervention and data collection. To capture the long-term effect and allow for season variability, follow-up data will be collected at three and six months after start of study intervention.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	SmartDrive Mx2+	Rear-mounted power assist

Timeline

• Start date: 2019-06-11
• Primary completion: 2020-11-09
• Completion: 2021-05-14
• First posted: 2020-01-27
• Last updated: 2022-02-23

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study