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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01746433
First received: December 7, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention
Supine Position
Elderly
Other: Sitting up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of the Mobility of Elderly Patients (> 65 Years) When Using the "l'Ergonome" Mobility Device: a Randomized, Monocentric Study

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Successful transition from a laying position to a sitting position [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
    yes/no


Secondary Outcome Measures:
  • Time needed to sit up [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]

    (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) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
    Shift in the patient's center of mass away from the x-axis of a pressure-sheet placed on the bed.


Enrollment: 37
Study Start Date: November 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.

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.

Experimental: 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

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.


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
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746433

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Emilie Viollet, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01746433     History of Changes
Other Study ID Numbers: LOCAL/2012/EVFN-02, 2012-A01141-42
Study First Received: December 7, 2012
Last Updated: March 17, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on September 30, 2014