Mobility of Elderly Patients When Using the "l'Ergonome" Mobility Device (L'ERGONOME)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Supine Position; Elderly

Treatments: Other: Sitting up

Study type: Interventional

Funder types: Other

Identifiers

NCT01746433

2012-A01141-42 (Other Identifier)

LOCAL/2012/EVFN-02

Details and patient eligibility

About

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

Full 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

Enrollment: 37 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Hanging Triangle Bar

Active Comparator group

Description:

The patients randomized to this group will use a hanging triangle bar for aid in sitting up exercises. No particular brand of hanging bar is targeted.

Treatment:

Other: Sitting up

Ergonome

Experimental group

Description:

The patients randomized to this group will use the "l'ERGONOME" device for aid in sitting up exercises. Commercial name of the device: SAM ERGONOM (TM) Manufacturer: Medicatlantic groupe Winncare, Le Pas du Château, 85680 Saint-Paul-Mont-Penit

Treatment:

Other: Sitting up