Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06698653

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

Led by WINNCARE · Updated on 2025-08-01

54

Participants Needed

3

Research Sites

50 weeks

Total Duration

On this page

Sponsors

W

WINNCARE

Lead Sponsor

P

Pôle Saint Hélier

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 and over
  • Unable to transfer from lying to sitting independently
  • Require technical assistance or help/supervision from another person
  • Using a medical bed
  • In-patient care for at least 3 weeks in a medical or rehabilitation facility
  • Have freely consented to participate
  • Affiliated with a social security scheme or entitled to benefits
Not Eligible

You will not qualify if you...

  • Unhealed spinal or pelvic fracture
  • Degenerative shoulder condition
  • Cardiovascular problems caused by physical exertion
  • Joint pain in the dorsolumbar spine
  • Behavioral disorders such as agitation, opposition, or dementia
  • Patients who are disabled, have low muscle tone, are agitated, not lucid, or at risk of falling requiring physical restraint
  • Unable to move independently
  • Cognitive impairment affecting reliable questionnaire responses
  • Motor or pain-related inability in both upper limbs preventing use of transfer aids
  • Height less than 146 cm
  • Weight less than 30 kg or more than 200 kg
  • Mattress incompatible with the device (length less than 190 cm or more than 200 cm; width less than 85 cm or more than 120 cm)
  • Vulnerable persons including pregnant or breastfeeding women
  • Persons deprived of liberty by legal or administrative decision
  • Persons under psychiatric care or admitted for non-research reasons
  • Persons unable to give prior consent due to emergency situations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

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

Ploemeur, France, 56270

Actively Recruiting

2

Fondation Ildys

Ploemeur, France, 56270

Active, Not Recruiting

3

Pôle Saint Hélier

Rennes, France, 35000

Actively Recruiting

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Research Team

E

Emilie Leblong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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