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

NCT ID: NCT04241003

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2021-05-14

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SmartDrive - baseline and intervention

One arm for all users. Baseline - two weeks data collection documenting usage of wheelchair prior to intervention. Introduction of SmartDrive, a time period to get used to the SmartDrive and then two weeks data collection documenting usage of wheelchair with the intervention.

Group Type: EXPERIMENTAL

SmartDrive Mx2+

Intervention Type: DEVICE

Rear-mounted power assist

Interventions

SmartDrive Mx2+

Rear-mounted power assist

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

• Cognitive impairment affecting the ability to operate the SmartDrive, as deemed by prescribing clinician
• Weigh more than 150 kilos 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 following two months, such as holiday, move, change jobs
• For any other reason not suitable for participation in the study, as deemed by prescribing clinician
• Do not use a smart phone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Permobil, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claes Hultling, Prof.

Role: PRINCIPAL_INVESTIGATOR

Spinalis

Locations

Stiftelsen Spinalis

Solna, , Sweden

Countries

Sweden

Other Identifiers

Per2018M01

Identifier Type: -

Identifier Source: org_study_id