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

NCT01746433 | Completed

• 2 other identifiers: LOCAL/2012/EVFN-022012-A01141-42
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Supine Position; Elderly

Outcome Measures

Primary Outcomes (1)

• Successful transition from a laying position to a sitting position

  yes/no

  Baseline (day 0)

Secondary Outcomes (2)

• Time needed to sit up

  baseline (day 0)

• Shift in the patient's center of mass (cm)

  baseline (day 0)

Study Arms (2)

Hanging Triangle Bar

ACTIVE COMPARATOR

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

Ergonome

EXPERIMENTAL

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

Interventions

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.

Ergonome; Hanging Triangle Bar

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Deception

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Emilie Viollet, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

FR (1)