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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
54
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
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
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape
Ploemeur, France
RECRUITINGFondation Ildys
Ploemeur, France
ACTIVE_NOT_RECRUITINGPôle Saint Hélier
Rennes, France
RECRUITINGThe 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
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
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