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Mobility LimitationVTTNCT01647802

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

A study testing Standing attempts with the "Vertic'Easy" Device, Standing attempts with the "Turner" Device and Standing attempts with the "Tina" device in people with Mobility Limitation, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Mobility Limitation
What is being tested?
Standing attempts with the "Vertic'Easy" Device, Standing attempts with the "Turner" Device and Standing attempts with the "Tina" device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
Sep 2012to Nov 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

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".

Read the 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).
Being tested
Standing attempts with the "Vertic'Easy" Device, Standing attempts with the "Turner" Device, Standing attempts with the "Tina" device
Keywords
standing devices, transfer devices
Medical subject headings
Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standing attempts with the "Vertic'Easy" DeviceDevice

    Also called Vertic'Easy, Manufacturer : HMS-VILGO, Parc Eurasanté - 243, Rue Salvador Allendé 59120 LOOS LEZ LILLE,

    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.

  • Standing attempts with the "Turner" DeviceDevice

    Also called Turner, Manufacturer : ETAC AB, Suède ; distributed in France by : FRANCE REHAB, ZA du Serroir, 54690 LAY SAINT CHRISTOPHE

    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

  • Standing attempts with the "Tina" deviceDevice

    Also called Tina, Manufacturer : ALTER ECO Santé, 9 Boulevard de Maurens, 31270 CUGNAUX

    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

Study groups in NCT01647802
Study groupRoleWhat they receive
Turner-Vertic'Easy-TinaExperimentalStanding will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
Receives: Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device
Turner-Tina-Vertic'EasyExperimentalStanding will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
Receives: Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device
Vertic'Easy-Turner-TinaExperimentalStanding will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
Receives: Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device
Vertic'Easy-Tina-TurnerExperimentalStanding will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
Receives: Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device
Tina-Turner-Vertic'EasyExperimentalStanding will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
Receives: Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device
Tina-Vertic'Easy-TurnerExperimentalStanding will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
Receives: Device: Standing attempts with the "Vertic'Easy" Device; Device: Standing attempts with the "Turner" Device; Device: Standing attempts with the "Tina" device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of forward flexion of the spine (position of maximum horizontal displacement of C7)

    cm

    Measured: Baseline (Day 0; cross-sectional study)

Secondary outcomes (4)

  1. Level of standing (maximum vertical displacement C7)

    cm

    Measured: Baseline (Day 0; transversal study)

  2. 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)

    degrees

    Measured: Baseline (Day 0; transversal study)

  3. Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)

    seconds

    Measured: Baseline (Day 0; transversal study)

  4. Verticalization achieved (yes/no)

    yes/no

    Measured: Baseline (Day 0; transversal study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01647802
Sponsor's protocol ID
LOCAL/2012/EV-03
Other IDs
2012-A00638-35
Acronym
VTT
Status last verified
Mar 2015
First submitted
17 Jul 2012
Last updated
26 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Standing attempts with the "Vertic'Easy" Device, Standing attempts with the "Turner" Device and Standing attempts with the "Tina" device in people with Mobility Limitation, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of forward flexion of the spine (position of maximum horizontal displacement of C7) (time frame: Baseline (Day 0; cross-sectional study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01647802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.

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