Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a … (NCT06698653) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request
France54 participantsStarted 2025-02-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
What they're measuring
1
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.