Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer (VTT)
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Nîmes Cedex 09, Frankreich, 30029
- CHU de Nîmes - Hopital Universitaire Caremeau
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: 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.
Andere Namen:
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
Andere Namen:
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
Andere Namen:
|
|
Experimental: 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.
Andere Namen:
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
Andere Namen:
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
Andere Namen:
|
|
Experimental: 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.
Andere Namen:
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
Andere Namen:
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
Andere Namen:
|
|
Experimental: 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.
Andere Namen:
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
Andere Namen:
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
Andere Namen:
|
|
Experimental: 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.
Andere Namen:
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
Andere Namen:
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
Andere Namen:
|
|
Experimental: 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.
Andere Namen:
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
Andere Namen:
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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Level of forward flexion of the spine (position of maximum horizontal displacement of C7)
Zeitfenster: Baseline (Day 0; cross-sectional study)
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cm
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Baseline (Day 0; cross-sectional study)
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Level of standing (maximum vertical displacement C7)
Zeitfenster: Baseline (Day 0; transversal study)
|
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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Baseline (Day 0; transversal study)
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yes/no
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Baseline (Day 0; transversal study)
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- LOCAL/2012/EV-03
- 2012-A00638-35 (Andere Kennung: RCB number)
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