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

NCT06698653 | Recruiting

• 1 other identifier: 2024-A01608-39
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

no Specific Condition Targeted

Outcome Measures

Primary Outcomes (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.

  At day 7 and day 14 of the experiment

Secondary Outcomes (6)

• The psychosocial impact, including quality of life, will be measured by comparing the scale for measuring the psychosocial impact of a technical aid (F-PIADS) at D7 and D14.

  At day 7 and day 14 of the experiment

• Satisfaction with the use of the SAM device will be measured by comparing the satisfaction scale with the technical aid (ESAT) at D7 or D14.

  At day 7 and day 14 of the experiment

• Device acceptability will be measured by a questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) model at D7 and D14.

  At day 7 and day 14 of the experiment

• Overall independence will be measured by comparing global FIM at D7 and D14.

  At day 7 and day 14 of the experiment

• Effort during supine-to-sitting transfers will be measured by comparing the duration of a supine-to-sitting transfer at the edge of the bed at D7 and D14, and by the average duration of the transfer during the period of use of the devices.

  At day 7 and day 14 of the experiment

Study Arms (2)

Phase A : Experimental

EXPERIMENTAL

Phase A corresponds to the experimental phase where the patient will use the experimental device during 7 days.

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

Phase B : Control

ACTIVE COMPARATOR

Phase B corresponds to the control phase where the patient will use the control device during 7 days.

Device: Over bed pole hoist (control device)

Interventions

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 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

Phase A : Experimental

Over bed pole hoist (control device) 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

Phase B : Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• WINNCARE: lead
• Pôle Saint Hélier: collaborator

Study Sites (3)

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape

Ploemeur, 56270, France

RECRUITING

Fondation Ildys

Ploemeur, 56270, France

ACTIVE NOT RECRUITING

Pôle Saint Hélier

Rennes, 35000, France

RECRUITING

Study Officials

• Emilie Leblong

  Fondation Saint Helier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Leblong

CONTACT

+33299295099; emilie.leblong@fondationsainthelier.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group 1 (phase A = experimental (7 days), then phase B= control (7 days)) Group 2 (phase B = control (7 days), then phase A = experimental (7 days))

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: February 11, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

FR (3)