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Completed

NCT Number: NCT01746433

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

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

Completed

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sitting up

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.

Primary outcomes

  1. Successful transition from a laying position to a sitting position

    Time frame: Baseline (day 0)

    yes/no

Secondary outcomes

  1. Time needed to sit up

    Time frame: 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"
  2. Shift in the patient's center of mass (cm)

    Time frame: baseline (day 0)

    Shift in the patient's center of mass away from the x-axis of a pressure-sheet placed on the bed.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: L'ERGONOME

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2012
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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