Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer

Not Applicable

Completed

• Conditions: Mobility Limitation
• Interventions: Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device

• Registration Number: NCT01647802
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The main objective of this study is to evaluate via a physiological analysis of the movements involved in standing, the level of forward flexion of the spine (in cm on the horizontal axis) obtained with the apparatus "Tina" and to compare levels obtained in the same patients with stander/transfer devices "Turner" and "Vertic'Easy".

Detailed Description

Secondary objectives of this study are to compare the three devices in terms of:

* the level recovery of the spine on the vertical axis (vertical displacement C7, cm)

* standing time, defined by the time between the start of the forward flexion and the beginning of the vertical stabilization phase (seconds)

* the success rate of the verticalization of the patient (the attempt is considered successful when the vertical position is held for 10 seconds).

Study Timeline

• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-24
• Study Start: 2012-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 is in stable medical condition (no complications in the last 10 days)
• The patient is unable to stand up by his/her self and requires help during transfers
• The patient has muscular force (quadriceps) > 3 out of 5.

Exclusion Criteria

• The patient is participating in another study
• 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 is pregnant, parturient, or breastfeeding
• The patient has a limited support from at least one lower limb
• The patient has an unstable fracture
• The patient has a fragile heart
• The patient has joint pain localized in the knee, hip or ankle.
• The patient has already used one of three mechanisms to help with standing and transfer used in this study
• Behavioral problems (opposition, agitation)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Turner-Vertic'Easy-Tina	Standing attempts with the "Vertic'Easy" Device	Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
Vertic'Easy-Turner-Tina	Standing attempts with the "Vertic'Easy" Device	Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
Turner-Vertic'Easy-Tina	Standing attempts with the "Turner" Device	Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
Turner-Tina-Vertic'Easy	Standing attempts with the "Vertic'Easy" Device	Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
Vertic'Easy-Turner-Tina	Standing attempts with the "Turner" Device	Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
Turner-Vertic'Easy-Tina	Standing attempts with the "Tina" device	Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
Vertic'Easy-Turner-Tina	Standing attempts with the "Tina" device	Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
Tina-Turner-Vertic'Easy	Standing attempts with the "Tina" device	Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
Turner-Tina-Vertic'Easy	Standing attempts with the "Tina" device	Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
Vertic'Easy-Tina-Turner	Standing attempts with the "Turner" Device	Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
Turner-Tina-Vertic'Easy	Standing attempts with the "Turner" Device	Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
Vertic'Easy-Tina-Turner	Standing attempts with the "Vertic'Easy" Device	Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
Tina-Turner-Vertic'Easy	Standing attempts with the "Vertic'Easy" Device	Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
Tina-Turner-Vertic'Easy	Standing attempts with the "Turner" Device	Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
Tina-Vertic'Easy-Turner	Standing attempts with the "Turner" Device	Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
Tina-Vertic'Easy-Turner	Standing attempts with the "Vertic'Easy" Device	Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
Vertic'Easy-Tina-Turner	Standing attempts with the "Tina" device	Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
Tina-Vertic'Easy-Turner	Standing attempts with the "Tina" device	Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.

Primary Outcome Measures

Name	Time	Method
Level of forward flexion of the spine (position of maximum horizontal displacement of C7)	Baseline (Day 0; cross-sectional study)	cm

Secondary Outcome Measures

Name	Time	Method
Angle of hip flexion (angle formed by the line connecting the acromion and the greater trochanter with the line connecting the greater trochanter and the lateral femoral condyle)	Baseline (Day 0; transversal study)	degrees
Level of standing (maximum vertical displacement C7)	Baseline (Day 0; transversal study)	cm
Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)	Baseline (Day 0; transversal study)	seconds
Verticalization achieved (yes/no)	Baseline (Day 0; transversal study)	yes/no

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France