An interventional study of Sitting up in Supine Position and Elderly, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-03-26.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Supportive care
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:
The secondary objectives of this study are to compare the following between study arms:
Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 594 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
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 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.
Successful transition from a laying position to a sitting position
yes/no
Time frame: Baseline (day 0)
Time needed to sit up
(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"
Time frame: baseline (day 0)
Shift in the patient's center of mass (cm)
Shift in the patient's center of mass away from the x-axis of a pressure-sheet placed on the bed.
Time frame: baseline (day 0)
The record gives a start of Nov 2013, a primary completion of Jan 2014 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Deception
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