Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request
WINNCARE
54 participants
Feb 11, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria18
- 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
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Interventions
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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06698653