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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Mobility Limitation

Treatments: Device: Standing attempts with the "Tina" device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Vertic'Easy" Device

Study type: Interventional

Funder types: Other

Identifiers

NCT01647802

LOCAL/2012/EV-03

2012-A00638-35 (Other Identifier)

Details and patient eligibility

About

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".

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Turner-Vertic'Easy-Tina

Experimental group

Description:

Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.

Treatment:

Device: Standing attempts with the "Turner" Device

Device: Standing attempts with the "Vertic'Easy" Device

Device: Standing attempts with the "Tina" device

Turner-Tina-Vertic'Easy

Experimental group

Description:

Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.

Treatment:

Device: Standing attempts with the "Turner" Device

Device: Standing attempts with the "Vertic'Easy" Device

Device: Standing attempts with the "Tina" device

Vertic'Easy-Turner-Tina

Experimental group

Description:

Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.

Treatment:

Device: Standing attempts with the "Turner" Device

Device: Standing attempts with the "Vertic'Easy" Device

Device: Standing attempts with the "Tina" device

Vertic'Easy-Tina-Turner

Experimental group

Description:

Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.

Treatment:

Device: Standing attempts with the "Turner" Device

Device: Standing attempts with the "Vertic'Easy" Device

Device: Standing attempts with the "Tina" device

Tina-Turner-Vertic'Easy

Experimental group

Description:

Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.

Treatment:

Device: Standing attempts with the "Turner" Device

Device: Standing attempts with the "Vertic'Easy" Device

Device: Standing attempts with the "Tina" device

Tina-Vertic'Easy-Turner

Experimental group

Description:

Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.

Treatment:

Device: Standing attempts with the "Turner" Device

Device: Standing attempts with the "Vertic'Easy" Device

Device: Standing attempts with the "Tina" device