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

NCT ID: NCT01746433

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-01-31

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

Conditions

Supine Position; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hanging Triangle Bar

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.

Group Type: ACTIVE_COMPARATOR

Sitting up

Intervention Type: OTHER

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.

Ergonome

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

Group Type: EXPERIMENTAL

Sitting up

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Viollet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Countries

France

Other Identifiers

2012-A01141-42

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/EVFN-02

Identifier Type: -

Identifier Source: org_study_id