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| Name | Class |
|---|---|
| Pôle Saint Hélier | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase A : Experimental | Experimental | Phase A corresponds to the experimental phase where the patient will use the experimental device during 7 days. |
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| Phase B : Control | Active Comparator | Phase B corresponds to the control phase where the patient will use the control device during 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Leblong | Contact | +33299295099 | emilie.leblong@fondationsainthelier.com |
| Name | Affiliation | Role |
|---|---|---|
| Emilie Leblong | Fondation Saint Helier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape | Recruiting | Ploemeur | 56270 | France |
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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))
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| 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 |
|
| 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 |
| 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. | At day 7 and day 14 of the experiment |
| Fondation Ildys | Active, not recruiting | Ploemeur | 56270 | France |
| Pôle Saint Hélier | Recruiting | Rennes | 35000 | France |
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