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

Mobility Limitation Clinical Trial

— VTT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647802
• Other study ID #: LOCAL/2012/EV-03
• Secondary ID: 2012-A00638-35
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: March 25, 2015
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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".

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

Device:
• Standing attempts with the "Vertic'Easy" 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.
• Standing attempts with the "Turner" 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
• Standing attempts with the "Tina" 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

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of forward flexion of the spine (position of maximum horizontal displacement of C7)	cm	Baseline (Day 0; cross-sectional study)	No
Secondary	Level of standing (maximum vertical displacement C7)	cm	Baseline (Day 0; transversal study)	No
Secondary	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	Baseline (Day 0; transversal study)	No
Secondary	Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)	seconds	Baseline (Day 0; transversal study)	No
Secondary	Verticalization achieved (yes/no)	yes/no	Baseline (Day 0; transversal study)	No