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

C

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)

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems