Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer (VTT)
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01647802
First received: July 17, 2012
Last updated: March 20, 2013
Last verified: March 2013
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Purpose
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".
| Condition | Intervention |
|---|---|
|
Mobility Limitation |
Device: Standing attempts with the "Vertic'Easy" Device Device: Standing attempts with the "Turner" Device Device: Standing attempts with the "Tina" device |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- Level of forward flexion of the spine (position of maximum horizontal displacement of C7) [ Time Frame: Baseline (Day 0; cross-sectional study) ] [ Designated as safety issue: No ]cm
Secondary Outcome Measures:
- Level of standing (maximum vertical displacement C7) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]degrees
- Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]seconds
- Verticalization achieved (yes/no) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]yes/no
| Enrollment: | 30 |
| Study Start Date: | September 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Turner-Vertic'Easy-Tina
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
|
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.
Other Names:
Device: 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
Other Names:
Device: 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
Other Names:
|
|
Experimental: Turner-Tina-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
|
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.
Other Names:
Device: 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
Other Names:
Device: 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
Other Names:
|
|
Experimental: Vertic'Easy-Turner-Tina
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
|
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.
Other Names:
Device: 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
Other Names:
Device: 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
Other Names:
|
|
Experimental: Vertic'Easy-Tina-Turner
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
|
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.
Other Names:
Device: 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
Other Names:
Device: 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
Other Names:
|
|
Experimental: Tina-Turner-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
|
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.
Other Names:
Device: 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
Other Names:
Device: 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
Other Names:
|
|
Experimental: Tina-Vertic'Easy-Turner
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
|
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.
Other Names:
Device: 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
Other Names:
Device: 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
Other Names:
|
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).
Eligibility| Ages Eligible for Study: | 75 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647802
Locations
| France | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | |
| Nîmes Cedex 09, France, 30029 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Emilie Viollet, MD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01647802 History of Changes |
| Other Study ID Numbers: | LOCAL/2012/EV-03, 2012-A00638-35 |
| Study First Received: | July 17, 2012 |
| Last Updated: | March 20, 2013 |
| Health Authority: | France: L’Agence nationale de sécurité du médicament et des produits de santé France: Committee for the Protection of Personnes |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
standing devices transfer devices |
Additional relevant MeSH terms:
|
Mobility Limitation Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013