Evaluating the Mobility Assistance System SAM Device to Help Adults Transfer from Lying to Sitting in Bed

What this Trial Is About

Researchers are evaluating the impact of the SAM Ergonom light SAM device on helping individuals who cannot transfer independently from lying down to sitting at the edge of a bed. This randomized, crossover, multi-center, open-label study compares the SAM device to an over bed pole hoist for improving transfer independence. The study focuses on participants who require assistance to transfer and aims to support reimbursement decisions for the SAM device. Participants will use both devices in two separate phases, each lasting 7 days. In Phase A, they will use the experimental SAM device, which is a removable structure fixed to the bed frame with a handle to assist sitting up. In Phase B, they will use the control device, an over bed pole hoist. The order of device use depends on randomization one group starts with the SAM device followed by the control device, and the other group uses the devices in the reverse order. During the study, therapists will directly observe participants to measure transfer independence using the Functional Independence Measure FIM at days 7 and 14. Secondary assessments include quality of life, satisfaction with the devices, device acceptability, overall independence, effort during transfers measured by duration, and the number and quality of lifts detected by bed sensors. The study involves in-patient participants using medical beds, with various evaluations conducted at the end of each 7-day device use period.

Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request