Mobility of Elderly Patients When Using the "l'Ergonome" Mobility Device

Not Applicable

Completed

• Conditions: Supine Position; Elderly

• Registration Number: NCT01746433
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-11
• Study Start: 2013-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Successful transition from a laying position to a sitting position	Baseline (day 0)	yes/no

Secondary Outcome Measures

Name	Time	Method
Time needed to sit up	baseline (day 0)	(minutes); The time needed to sit up is defined as follows: * The minimum time recorded for two attempts in the "Hanging Triangle Bar" group; * The maximum time recorded for two attempts in the "Ergonome group"
Shift in the patient's center of mass (cm)	baseline (day 0)	Shift in the patient's center of mass away from the x-axis of a pressure-sheet placed on the bed.

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France