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Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request
Sponsor: WINNCARE
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2025-02-11
Completion Date
2026-02
Last Updated
2025-08-01
Healthy Volunteers
No
Conditions
Interventions
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
Locations (3)
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape
Ploemeur, France
Fondation Ildys
Ploemeur, France
Pôle Saint Hélier
Rennes, France