Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request (SAM-24)

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.

Study Overview

• Status: Recruiting
• Conditions: no Specific Condition Targeted
• Intervention / Treatment: 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; Device: Over bed pole hoist (control device)

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie Leblong; Phone Number: +33299295099; Email: emilie.leblong@fondationsainthelier.com

Study Locations

• France
  • Ploemeur, France, 56270
    • Recruiting
    • Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape
    • Contact: Stephanie Leplaideur; Phone Number: +33297826023; Email: stephanie.leplaideur@vyv3.fr
    • Principal Investigator: Stéphanie LEPLAIDEUR
  • Ploemeur, France, 56270
    • Active, not recruiting
    • Fondation Ildys
  • Rennes, France, 35000
    • Recruiting
    • Pôle Saint Hélier
    • Principal Investigator: Emilie LEBLONG
    • Contact: Emilie Leblong; Phone Number: +33299295099; Email: emilie.leblong@fondationsainthelier.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 and over
• Unable to transfer from lying to sitting independently
• Requiring technical assistance or the help or supervision of a third party
• Using a medical bed
• In-patient care for a minimum of 3 weeks in a medical or rehabilitation facility
• Having freely consented to participate
• Affiliated with a social security scheme or entitled to benefits

Exclusion Criteria:

• Non-consolidated spinal or pelvic fracture
• Degenerative shoulder
• Cardiovascular disorders caused by physical exertion
• Joint pain localized to dorsolumbar spine
• Behavioural disorders (opposition, agitation, dementia)
• Invalid patient (disability, low tonicity), agitated, not lucid (confused, disoriented) at risk of falling, requiring physical restraint with bed rails on medical prescription
• Functional inability to move independently
• Cognitive impairment affecting reliability of response to questionnaires
• Motor or algic incapacity of the 2 upper limbs not allowing the use of a technical aid (lifting frame or SAM) to ensure transfer from lying to sitting position in bed
• Patient less than 146 cm tall
• Patient weighing less than 30 kg or more than 200 kg
• Patient with a mattress incompatible with the OS'CARE device
• Mattress length less than 190 cm or greater than 200 cm, and width less than 85 cm or greater than 120 cm

In addition, vulnerable persons covered by articles L. 1121-5 to 8 and L. 1122-1-2 of the French Public Health Code are excluded from the study:

• Pregnant, parturient or breast-feeding women
• Persons deprived of their liberty by judicial decision (including guardianship, curatorship and safeguard of justice) or administrative decision
• Persons under psychiatric care or admitted to a health or social institution for purposes other than research.
• Person in an emergency situation unable to give prior consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase A : Experimental; Phase A corresponds to the experimental phase where the patient will use the experimental device during 7 days.	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
Active Comparator: Phase B : Control; Phase B corresponds to the control phase where the patient will use the control 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
The psychosocial impact, including quality of life, will be measured by comparing the scale for measuring the psychosocial impact of a technical aid (F-PIADS) at D7 and D14.	At day 7 and day 14 of the experiment
Satisfaction with the use of the SAM device will be measured by comparing the satisfaction scale with the technical aid (ESAT) at D7 or D14.	At day 7 and day 14 of the experiment
Device acceptability will be measured by a questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) model at D7 and D14.	At day 7 and day 14 of the experiment
Overall independence will be measured by comparing global FIM at D7 and D14.	At day 7 and day 14 of the experiment
Effort during supine-to-sitting transfers will be measured by comparing the duration of a supine-to-sitting transfer at the edge of the bed at D7 and D14, and by the average duration of the transfer during the period of use of the devices.	At day 7 and day 14 of the experiment
The quantity and quality of the transfer will be evaluated indirectly by the total number of lifts and attempted lifts from the bed over 7 days for each device, measured by OS'CARE bed presence sensors.	At day 7 and day 14 of the experiment

Collaborators and Investigators

• Sponsor: WINNCARE
• Collaborators: Pôle Saint Hélier
• Investigators: Principal Investigator: Emilie Leblong, Fondation Saint Helier

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A01608-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No