Using the SAM Ergonom light bedside handle to help people sit up in bed
Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request
This project will see if the SAM Ergonom light bedside handle helps adults who cannot sit up in bed on their own to move from lying to sitting more independently than using a standard over-bed pole.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Winncare Industry-sponsored |
| Locations | 3 sites (Ploemeur and 2 other locations) |
| Trial ID | NCT06698653 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label, crossover, multi-center study compares the SAM Ergonom light, a removable handle structure attached to a medical bed, with a standard over-bed pole hoist for helping patients move from supine to sitting at the edge of the bed. Eligible inpatients who cannot transfer independently will be randomized to device sequence and each participant will use both devices so outcomes can be compared within the same person. The trial uses an intention-to-treat analysis across several French rehabilitation centers to measure independence in bed transfers. Outcomes will focus on transfer independence and practical usability of the devices in routine care.
Who should consider this trial
Good fit: Adults (18+) who are inpatients using a medical bed for at least three weeks, unable to transfer from lying to sitting without technical assistance or supervision, and able to give informed consent are the intended participants.
Not a fit: Patients with non-consolidated spinal or pelvic fractures, severe shoulder or bilateral upper-limb motor impairments, major cognitive or behavioral disturbances, or other conditions preventing safe use of the handle are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, the SAM device could increase patients' ability to sit up without help, reduce caregiver assistance, and lower the risk of transfer-related injuries.
How similar studies have performed: Mechanical transfer aids and bedside handles have shown modest benefits in prior reports, but randomized crossover data specific to the SAM Ergonom light are limited, so this evaluation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ploemeur and 2 other locations
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape — Ploemeur, France (Recruiting)
- Fondation Ildys — Ploemeur, France (Active_not_recruiting)
- Pôle Saint Hélier — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Emilie Leblong — Fondation Saint Helier
- Study coordinator: Emilie Leblong
- Email: emilie.leblong@fondationsainthelier.com
- Phone: +33299295099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.