Skip to main content
OpenTrials
Completed

NCT Number: NCT01647802

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

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".

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standing attempts with the "Vertic'Easy" Device

Device

Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.

Other names: Vertic'Easy, Manufacturer : HMS-VILGO, Parc Eurasanté - 243, Rue Salvador Allendé 59120 LOOS LEZ LILLE,

Standing attempts with the "Turner" Device

Device

Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes

Other names: Turner, Manufacturer : ETAC AB, Suède ; distributed in France by : FRANCE REHAB, ZA du Serroir, 54690 LAY SAINT CHRISTOPHE

Standing attempts with the "Tina" device

Device

Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes

Other names: Tina, Manufacturer : ALTER ECO Santé, 9 Boulevard de Maurens, 31270 CUGNAUX

Primary outcomes

  1. Level of forward flexion of the spine (position of maximum horizontal displacement of C7)

    Time frame: Baseline (Day 0; cross-sectional study)

    cm

Secondary outcomes

  1. Level of standing (maximum vertical displacement C7)

    Time frame: Baseline (Day 0; transversal study)

    cm

  2. 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)

    Time frame: Baseline (Day 0; transversal study)

    degrees

  3. Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)

    Time frame: Baseline (Day 0; transversal study)

    seconds

  4. Verticalization achieved (yes/no)

    Time frame: Baseline (Day 0; transversal study)

    yes/no

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: VTT

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 24, 2012
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.