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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.