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RECRUITING
NCT06698653
NA

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

Sponsor: WINNCARE

View on ClinicalTrials.gov

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

Interventions

DEVICE

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

DEVICE

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