no Specific Condition TargetedSAM-24NCT06698653
Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request
A study testing 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 in people with no Specific Condition Targeted, run by WINNCARE at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- no Specific Condition Targeted
- What is being tested?
- 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Feb 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 2 recruiting
- Recruiting
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape
Ploemeur, 56270
Stephanie Leplaideur, +33297826023, stephanie.leplaideur@vyv3.fr
Stephanie Leplaideur
- Active, not recruiting
Fondation Ildys
Ploemeur, 56270
- Recruiting
Pôle Saint Hélier
Rennes, 35000
Emilie Leblong, +33299295099, emilie.leblong@fondationsainthelier.com
Emilie Leblong
About this study
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
- Being tested
- 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, Over bed pole hoist (control device)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAM device (experimental): a removable structure, fixed to the horizontal frame of the medical bed, equipped with a handle to assist the sitting-up processDevice
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)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 group | Role | What they receive |
|---|---|---|
| Phase A : Experimental | Experimental | Phase A corresponds to the experimental phase where the patient will use the experimental device during 7 days. Receives: 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. Receives: Device: Over bed pole hoist (control device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At day 7 and day 14 of the experiment
Overall independence will be measured by comparing global FIM at D7 and D14.
Measured: 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.
Measured: At day 7 and day 14 of the experiment
The quantity and quality of the transfer will be evaluated indirectly by the total number of lifts and attempted lifts from the bed over 7 days for each device, measured by OS'CARE bed presence sensors.
Measured: At day 7 and day 14 of the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start11 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no Specific Condition TargetedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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))
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WINNCARE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pôle Saint Hélier
- Responsible party
- Sponsor
- Investigators
- Emilie Leblong, Principal investigator, Fondation Saint Helier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698653
- Sponsor's protocol ID
- 2024-A01608-39
- Acronym
- SAM-24
- Status last verified
- Jul 2025
- First submitted
- 18 Nov 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Benefit of the Mobility Assistance System (SAM) on Transfer Independence for a Reimbursement Request
- ClinicalTrials.gov ID
- NCT06698653
- Acronym / sponsor ID
- SAM-24 / 2024-A01608-39
- Conditions
- no Specific Condition Targeted
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- WINNCAREIndustry (pharma, biotech, devices)
- Collaborators
- Pôle Saint Hélier
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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))
| Arm | Type | Receives |
|---|---|---|
| Phase A : Experimental | Experimental | 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 processPhase A corresponds to the experimental phase where the patient will use the experimental device during 7 days. |
| Phase B : Control | Active comparator | Device: Over bed pole hoist (control device)Phase B corresponds to the control phase where the patient will use the control device during 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAM device (experimental): a removable structure, fixed to the horizontal frame of the medical bed, equipped with a handle to assist the sitting-up processThe 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 | Device | Phase A : Experimental |
| 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 | Device | Phase B : Control |
Primary outcome
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.
Time frame: At day 7 and day 14 of the experiment
6 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: At day 7 and day 14 of the experiment
Overall independence will be measured by comparing global FIM at D7 and D14.
Time frame: 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.
Time frame: At day 7 and day 14 of the experiment
The quantity and quality of the transfer will be evaluated indirectly by the total number of lifts and attempted lifts from the bed over 7 days for each device, measured by OS'CARE bed presence sensors.
Time frame: At day 7 and day 14 of the experiment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilie Leblong principal investigator
Fondation Saint Helier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with no Specific Condition Targeted, run by WINNCARE at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Leblong (+33299295099, emilie.leblong@fondationsainthelier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: At day 7 and day 14 of the experiment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.