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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: SmartDrive Mx2+

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Solna, Sweden, 169 70
    • Stiftelsen Spinalis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: SmartDrive Mx2+; Rear-mounted power assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wheelchair usage per day (time)	Data captured by study specific smart watch to document usage of wheelchair	Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
Change in wheelchair usage per day (distance)	Data captured by study specific smart watch to document usage of wheelchair	Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
Change in activity level of patient reported wheelchair use	Paper diary for activity level (high, medium, low) rated by the participant every evening.	Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain in upper extremities, WUSPI	Wheelchair user shoulder pain index (WUSPI). WUSPI is a simple and effective self-report questionnaire for quickly measuring the functional cost of shoulder pain in wheelchair users. The WUSPI targets activity limitation resulting from shoulder pain (4 subsections), including wheelchair transfers, wheelchair mobility, selfcare and general activities.	At visit 2 and 3 (start and end of intervention) and at 3 and 6 months Follow up for a period of up to one year
Pain in upper extremities, ISCOS	The International Spinal Cord Injury Pain Basic Data Set is a questionnaire addressing clinically relevant core questions concerning SCI-related pain.	At visit 2 and 3 (start and end of intervention) and at 3 and 6 months Follow up for a period of up to one year
Wheelchair Outcome Measure WhOM	The WhOM is a client-centred two-part measure of wheelchair and seating system intervention, documenting expectations of the new intervention (part 1) which is followed up in the second part.	At visit 2 and 3 (start and end of intervention) and at 3 and 6 months Follow up for a period of up to one year
Change in pain level of patient reported wheelchair use	Paper diary for pain score on a Likert scale rated by the participant every evening.	Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)

Collaborators and Investigators

• Sponsor: Permobil, Inc.
• Investigators: Principal Investigator: Claes Hultling, Prof., Spinalis

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): November 9, 2020
• Study Completion (Actual): May 14, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Arthralgia; Shoulder Pain; Spinal Cord Injuries
• Other Study ID Numbers: Per2018M01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes