Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer (VTT)
25. marts 2015 opdateret af: 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".
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Nîmes Cedex 09, Frankrig, 30029
- CHU de Nimes - Hopital Universitaire Caremeau
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
75 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
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
Andre navne:
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
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
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
Andre navne:
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
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
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
Andre navne:
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
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
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
Andre navne:
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
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
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
Andre navne:
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
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
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
Andre navne:
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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of forward flexion of the spine (position of maximum horizontal displacement of C7)
Tidsramme: Baseline (Day 0; cross-sectional study)
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cm
|
Baseline (Day 0; cross-sectional study)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Level of standing (maximum vertical displacement C7)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline (Day 0; transversal study)
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yes/no
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Baseline (Day 0; transversal study)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2012
Primær færdiggørelse (Faktiske)
1. november 2012
Studieafslutning (Faktiske)
1. november 2012
Datoer for studieregistrering
Først indsendt
17. juli 2012
Først indsendt, der opfyldte QC-kriterier
23. juli 2012
Først opslået (Skøn)
24. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. marts 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. marts 2015
Sidst verificeret
1. marts 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LOCAL/2012/EV-03
- 2012-A00638-35 (Anden identifikator: RCB number)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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