Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer (VTT)
25 marca 2015 zaktualizowane przez: Centre Hospitalier Universitaire de Nīmes
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".
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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).
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
30
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Nîmes Cedex 09, Francja, 30029
- CHU de Nimes - Hopital Universitaire Caremeau
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
75 lat i starsze (Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Turner-Vertic'Easy-Tina
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
|
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.
Inne nazwy:
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
Inne nazwy:
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
Inne nazwy:
|
|
Eksperymentalny: Turner-Tina-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
|
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.
Inne nazwy:
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
Inne nazwy:
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
Inne nazwy:
|
|
Eksperymentalny: Vertic'Easy-Turner-Tina
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
|
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.
Inne nazwy:
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
Inne nazwy:
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
Inne nazwy:
|
|
Eksperymentalny: Vertic'Easy-Tina-Turner
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
|
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.
Inne nazwy:
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
Inne nazwy:
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
Inne nazwy:
|
|
Eksperymentalny: Tina-Turner-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
|
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.
Inne nazwy:
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
Inne nazwy:
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
Inne nazwy:
|
|
Eksperymentalny: Tina-Vertic'Easy-Turner
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
|
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.
Inne nazwy:
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
Inne nazwy:
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
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Level of forward flexion of the spine (position of maximum horizontal displacement of C7)
Ramy czasowe: Baseline (Day 0; cross-sectional study)
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cm
|
Baseline (Day 0; cross-sectional study)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Level of standing (maximum vertical displacement C7)
Ramy czasowe: Baseline (Day 0; transversal study)
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cm
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Baseline (Day 0; transversal study)
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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)
Ramy czasowe: Baseline (Day 0; transversal study)
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degrees
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Baseline (Day 0; transversal study)
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Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)
Ramy czasowe: Baseline (Day 0; transversal study)
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seconds
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Baseline (Day 0; transversal study)
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Verticalization achieved (yes/no)
Ramy czasowe: Baseline (Day 0; transversal study)
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yes/no
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Baseline (Day 0; transversal study)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 września 2012
Zakończenie podstawowe (Rzeczywisty)
1 listopada 2012
Ukończenie studiów (Rzeczywisty)
1 listopada 2012
Daty rejestracji na studia
Pierwszy przesłany
17 lipca 2012
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 lipca 2012
Pierwszy wysłany (Oszacować)
24 lipca 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
26 marca 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
25 marca 2015
Ostatnia weryfikacja
1 marca 2015
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- LOCAL/2012/EV-03
- 2012-A00638-35 (Inny identyfikator: RCB number)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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