Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request
Condition(s) studied
Investigational drug(s) / intervention(s)
SAM device (experimental): a removable structure, fixed to the horizontal frame of the medical bed, equipped with a handle to assist the sitting-up process: The patients will use the experimental device during 7 days straight as well as the comparator during 7 days straight. The order in which they will use each device will depend on the groupe they have been randomized in : - Groupe 1 : Experimental device during 7 days then control device during 7 days - Groupe 2 : Control device during 7 days then experimental device during 7 days
Over bed pole hoist (control device): The patients will use the experimental device during 7 days straight as well as the comparator during 7 days straight. The order in which they will use each device will depend on the groupe they have been randomized in : - Groupe 1 : Experimental device during 7 days then control device during 7 days - Groupe 2 : Control device during 7 days then experimental device during 7 days
Study summary
This is a randomized, cross-over, multi-center, intention-to-treat, open-label study to assess the impact of the SAM Ergonom light (SAM) device on independence when transferring from the supine to the sitting position at the edge of the bed in a population of individuals with an inability to transfer independently from the supine to the sitting position in bed, compared with the use of a raising arm.
Eligibility
Primary outcome measure(s)
- The impact on transfer independence will be measured by comparing the "bed transfer" item of the Functional Independence Measure (FIM), carried out at D7 and D14 by direct observation of the participant by the therapist. — At day 7 and day 14 of the experiment
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape | Ploemeur | France | Recruiting |
| Fondation Ildys | Ploemeur | France | Active Not Recruiting |
| Pôle Saint Hélier | Rennes | France | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06698653 on ClinicalTrials.gov ↗ ← All trials in France