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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• 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. [Срок оценки: At day 7 and day 14 of the experiment]

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: At day 7 and day 14 of the experiment]
• Overall independence will be measured by comparing global FIM at D7 and D14. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: At day 7 and day 14 of the experiment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 3 центра

• Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles (CMRRF) de Kerpape — Ploemeur
• Fondation Ildys — Ploemeur
• Pôle Saint Hélier — Rennes

Идентификаторы

NCT: NCT06698653 · 2024-A01608-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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