Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT04241003
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.
Study:
NCT04241003
Study Brief:
Protocol Section:
NCT04241003