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

WINNCARE

Status: Enrolling

Conditions: no Specific Condition Targeted

Treatments: Device: Over bed pole hoist (control device); 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06698653

2024-A01608-39

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Phase A : Experimental

Experimental group

Description:

Phase A corresponds to the experimental phase where the patient will use the experimental device during 7 days.

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

Phase B : Control

Active Comparator group

Description:

Phase B corresponds to the control phase where the patient will use the control device during 7 days.

Treatment:

Device: Over bed pole hoist (control device)