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

Primary Purpose

Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standing attempts with the "Vertic'Easy" Device
Standing attempts with the "Turner" Device
Standing attempts with the "Tina" device
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mobility Limitation focused on measuring standing devices, transfer devices

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Turner-Vertic'Easy-Tina

Turner-Tina-Vertic'Easy

Vertic'Easy-Turner-Tina

Vertic'Easy-Tina-Turner

Tina-Turner-Vertic'Easy

Tina-Vertic'Easy-Turner

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Level of standing (maximum vertical displacement C7)
cm
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)
degrees
Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)
seconds
Verticalization achieved (yes/no)
yes/no

Full Information

First Posted
July 17, 2012
Last Updated
March 25, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01647802
Brief Title
Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer
Acronym
VTT
Official Title
Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
Keywords
standing devices, transfer devices

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Turner-Vertic'Easy-Tina
Arm Type
Experimental
Arm Description
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
Arm Title
Turner-Tina-Vertic'Easy
Arm Type
Experimental
Arm Description
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
Arm Title
Vertic'Easy-Turner-Tina
Arm Type
Experimental
Arm Description
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
Arm Title
Vertic'Easy-Tina-Turner
Arm Type
Experimental
Arm Description
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
Arm Title
Tina-Turner-Vertic'Easy
Arm Type
Experimental
Arm Description
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
Arm Title
Tina-Vertic'Easy-Turner
Arm Type
Experimental
Arm Description
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
Intervention Type
Device
Intervention Name(s)
Standing attempts with the "Vertic'Easy" Device
Other Intervention Name(s)
Vertic'Easy, Manufacturer : HMS-VILGO, Parc Eurasanté - 243, Rue Salvador Allendé 59120 LOOS LEZ LILLE,
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standing attempts with the "Turner" Device
Other Intervention Name(s)
Turner, Manufacturer : ETAC AB, Suède ; distributed in France by : FRANCE REHAB, ZA du Serroir, 54690 LAY SAINT CHRISTOPHE
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Standing attempts with the "Tina" device
Other Intervention Name(s)
Tina, Manufacturer : ALTER ECO Santé, 9 Boulevard de Maurens, 31270 CUGNAUX
Intervention Description
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
Primary Outcome Measure Information:
Title
Level of forward flexion of the spine (position of maximum horizontal displacement of C7)
Description
cm
Time Frame
Baseline (Day 0; cross-sectional study)
Secondary Outcome Measure Information:
Title
Level of standing (maximum vertical displacement C7)
Description
cm
Time Frame
Baseline (Day 0; transversal study)
Title
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)
Description
degrees
Time Frame
Baseline (Day 0; transversal study)
Title
Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)
Description
seconds
Time Frame
Baseline (Day 0; transversal study)
Title
Verticalization achieved (yes/no)
Description
yes/no
Time Frame
Baseline (Day 0; transversal study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Viollet, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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