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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01647802
Acronym
VTT
Enrollment
30
Registered
2012-07-24
Start date
2012-09-30
Completion date
2012-11-30
Last updated
2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mobility Limitation

Keywords

standing devices, transfer devices

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).

Interventions

DEVICEStanding 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.

DEVICEStanding 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

DEVICEStanding 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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Level of forward flexion of the spine (position of maximum horizontal displacement of C7)Baseline (Day 0; cross-sectional study)cm

Secondary

MeasureTime frameDescription
Level of standing (maximum vertical displacement C7)Baseline (Day 0; transversal study)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)Baseline (Day 0; transversal study)degrees
Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)Baseline (Day 0; transversal study)seconds
Verticalization achieved (yes/no)Baseline (Day 0; transversal study)yes/no

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026