Clinical trial NCT04241003: Effects of the SmartDrive on Mobility, Activity and Shoulder Pain Among People With SCI Using Manual Wheelchairs
Official title: Effects of the SmartDrive on Mobility, Activity and Shoulder Pain Among People With SCI Using Manual Wheelchairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Permobil, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in wheelchair usage per day (time)
timeFrame: Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
measure: Change in wheelchair usage per day (distance)
timeFrame: Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
measure: Change in activity level of patient reported wheelchair use
timeFrame: Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
Secondary outcomes:
measure: Pain in upper extremities, WUSPI
timeFrame: 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
measure: Pain in upper extremities, ISCOS
timeFrame: 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
measure: Wheelchair Outcome Measure WhOM
timeFrame: 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
measure: Change in pain level of patient reported wheelchair use
timeFrame: Two weeks during baseline (without SmartDrive) and two weeks during intervention (with SmartDrive)
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Stiftelsen Spinalis
Study officials:
affiliation: Spinalis
name: Claes Hultling, Prof.
role: PRINCIPAL_INVESTIGATOR
References: