Ireland
--:--IST
Recruiting Not applicable

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

NCT06698653 · tracked via the Priya Life Science France tracker
Sponsor
WINNCARE
Phase
Not applicable
Started
2025-02-11
Last updated
2025-08-01

Condition(s) studied

no Specific Condition Targeted

Investigational drug(s) / intervention(s)

SAM device (experimental): a removable structure, fixed to the horizontal frame of the medical bed, equipped with a handle to assist the sitting-up processOver bed pole hoist (control 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: 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

Over bed pole hoist (control device): 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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. — At day 7 and day 14 of the experiment

Trial sites (3)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06698653 on ClinicalTrials.gov ↗ ← All trials in France