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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartDrive - baseline and intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartDrive Mx2+ | Device | Rear-mounted power assist |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claes Hultling, Prof. | Spinalis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stiftelsen Spinalis | Solna | 169 70 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35793399 | Derived | Butler Forslund E, Lofvenmark I. Effects of the SmartDrive on mobility, activity, and shoulder pain among manual wheelchair users with spinal cord injury - a prospective long-term cohort pilot study. Disabil Rehabil Assist Technol. 2024 Feb;19(2):397-406. doi: 10.1080/17483107.2022.2091670. Epub 2022 Jul 5. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2023 | May 19, 2023 | 3 |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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) |
| D014947 | Wounds and Injuries |