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

Elderly Clinical Trial

— L'ERGONOME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746433
• Other study ID #: LOCAL/2012/EVFN-02
• Secondary ID: 2012-A01141-42
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: March 25, 2015
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Elderly
• Supine Position

Intervention

Other:
• Sitting up
The patient is positioned on a Winncare type bed dressed with a pressure-sensor sheet and equipped with either a hanging triangle bar (supporting arm of the bar is adjusted to 30 degrees) or an ERGONOME device according to randomization. The patient is first installed on the bed in a strictly supine position, the pelvis centered, and the greater trochanter over the fold of the backrest. The investigator then gives instructions on how to use the randomized device (correct hand placement). The patient is asked to sit up twice (two consecutive attempts). The first attempt is a learning attempt. The observations necessary for this study will be taken on the second attempt. Thus the second sitting attempt is timed, video-taped and recorded via the pressure-sensor sheet beneath the patient.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful transition from a laying position to a sitting position	yes/no	Baseline (day 0)	No
Secondary	Time needed to sit up	(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"	baseline (day 0)	No
Secondary	Shift in the patient's center of mass (cm)	Shift in the patient's center of mass away from the x-axis of a pressure-sheet placed on the bed.	baseline (day 0)	No