Evaluation of the Mobility of Elderly Patients (> 65 Years) When Using the "l'Ergonome" Mobility Device: a Randomized, Monocentric Study

Centre Hospitalier Universitaire de Nīmes1 site in 1 country37 target enrollmentNovember 2013

ConditionsSupine Position Elderly

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Supine Position
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 37
Locations: 1
Primary Endpoint: Successful transition from a laying position to a sitting position
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this study is to compare the percentage of patients that successfully pass from a laying position to a sitting position in less than 10 seconds between study arms:

experimental arm: these patients will use the ERGONOME device to help them sit up
standard arm: these patients will use traditional hanging triangle bar to help them sit up

Detailed Description

The secondary objectives of this study are to compare the following between study arms: * The average time (s) required to sit up * How the patient's center of gravity moves in relation to a fixed axis

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

January 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient must have given his/her informed and signed consent
•The patient must be insured or beneficiary of a health insurance plan
•The patient must be in stable medical condition (no complications for the last 10 days)
•The patient is incapable of changing from a laying position to a sitting position by his/herself in \<10 secondes, and requires help for such movement
•The patient has a sitting-balance score \> 2/4 (Brun et al 1991: Actual Rééduc Réadaptat: (16):412-7))

Exclusion Criteria

•The patient is in an exclusion period determined by a previous study
•The patient is under judicial protection, under tutorship or curatorship
•The patient refuses to sign the consent
•It is impossible to correctly inform the patient
•The patient has fractured vertebrae or pelvis
•The patient has a weak heart
•The patient has joint pain localized to the dorso-lumbar region
•The patient has behavioral disorders (opposition, agitation, dementia)
•The patient has a medical prescription for physical restraint by bed rails.
•The patient is incapable of understanding the utility of the proposed technical aide, and using it for rolling and sitting up (notion of compliance).