Supine PositionL'ERGONOMENCT01746433
Mobility of Elderly Patients When Using the "l'Ergonome" Mobility Device
A study testing Sitting up in people with Supine Position and Elderly, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to compare the percentage of patients that successfully pass from a laying position to a sitting position in less than 10 seconds between study arms: experimental arm: these patients will use the ERGONOME device to help them sit up standard arm: these patients will use traditional… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Supine Position, Elderly
- What is being tested?
- Sitting up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jan 2014
- 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 65 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 must be in stable medical condition (no complications for the last 10 days)
- The patient is incapable of changing from a laying position to a sitting position by his/herself in <10 secondes, and requires help for such movement
- The patient has a sitting-balance score > 2/4 (Brun et al 1991: Actual Rééduc Réadaptat: (16):412-7))
Who cannot join
- 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 has fractured vertebrae or pelvis
- The patient has a weak heart
Show all 10Show fewer
- The patient has joint pain localized to the dorso-lumbar region
- The patient has behavioral disorders (opposition, agitation, dementia)
- The patient has a medical prescription for physical restraint by bed rails.
- The patient is incapable of understanding the utility of the proposed technical aide, and using it for rolling and sitting up (notion of compliance).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Mobility of Elderly Patients (> 65 Years) When Using the "l'Ergonome" Mobility Device: a Randomized, Monocentric Study
The main objective of this study is to compare the percentage of patients that successfully pass from a laying position to a sitting position in less than 10 seconds between study arms:
- experimental arm: these patients will use the ERGONOME device to help them sit up
- standard arm: these patients will use traditional hanging triangle bar to help them sit up
Read the detailed description
The secondary objectives of this study are to compare the following between study arms:
- The average time (s) required to sit up
- How the patient's center of gravity moves in relation to a fixed axis
- Conditions
- Supine Position, Elderly
- Being tested
- Sitting up
- Medical subject headings
- Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting upOther
The patient is positioned on a Winncare type bed dressed with a pressure-sensor sheet and equipped with either a hanging triangle bar (supporting arm of the bar is adjusted to 30 degrees) or an ERGONOME device according to randomization.
The patient is first installed on the bed in a strictly supine position, the pelvis centered, and the greater trochanter over the fold of the backrest.
The investigator then gives instructions on how to use the randomized device (correct hand placement).
The patient is asked to sit up twice (two consecutive attempts). The first attempt is a learning attempt. The observations necessary for this study will be taken on the second attempt. Thus the second sitting attempt is timed, video-taped and recorded via the pressure-sensor sheet beneath the patient.
| Study group | Role | What they receive |
|---|---|---|
| Hanging Triangle Bar | Active comparator | The patients randomized to this group will use a hanging triangle bar for aid in sitting up exercises.
No particular brand of hanging bar is targeted. Receives: Other: Sitting up |
| Ergonome | Experimental | The patients randomized to this group will use the "l'ERGONOME" device for aid in sitting up exercises.
Commercial name of the device: SAM ERGONOM (TM)
Manufacturer: Medicatlantic groupe Winncare, Le Pas du Château, 85680 Saint-Paul-Mont-Penit Receives: Other: Sitting up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful transition from a laying position to a sitting position
yes/no
Measured: Baseline (day 0)
Secondary outcomes (2)
Time needed to sit up
(minutes)
The time needed to sit up is defined as follows:
- The minimum time recorded for two attempts in the "Hanging Triangle Bar" group
- The maximum time recorded for two attempts in the "Ergonome group"
Measured: baseline (day 0)
Shift in the patient's center of mass (cm)
Shift in the patient's center of mass away from the x-axis of a pressure-sheet placed on the bed.
Measured: baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supine PositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Viollet, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746433
- Sponsor's protocol ID
- LOCAL/2012/EVFN-02
- Other IDs
- 2012-A01141-42
- Acronym
- L'ERGONOME
- Status last verified
- Mar 2015
- First submitted
- 7 Dec 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Mobility of Elderly Patients (> 65 Years) When Using the "l'Ergonome" Mobility Device: a Randomized, Monocentric Study
- ClinicalTrials.gov ID
- NCT01746433
- Acronym / sponsor ID
- L'ERGONOME / LOCAL/2012/EVFN-02
- Conditions
- Supine Position, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare the percentage of patients that successfully pass from a laying position to a sitting position in less than 10 seconds between study arms:
- experimental arm: these patients will use the ERGONOME device to help them sit up
- standard arm: these patients will use traditional hanging triangle bar to help them sit up
Detailed description
The secondary objectives of this study are to compare the following between study arms:
- The average time (s) required to sit up
- How the patient's center of gravity moves in relation to a fixed axis
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hanging Triangle Bar | Active comparator | Other: Sitting upThe patients randomized to this group will use a hanging triangle bar for aid in sitting up exercises. No particular brand of hanging bar is targeted. |
| Ergonome | Experimental | Other: Sitting upThe patients randomized to this group will use the "l'ERGONOME" device for aid in sitting up exercises. Commercial name of the device: SAM ERGONOM (TM) Manufacturer: Medicatlantic groupe Winncare, Le Pas du Château, 85680 Saint-Paul-Mont-Penit |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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 must be in stable medical condition (no complications for the last 10 days)
- The patient is incapable of changing from a laying position to a sitting position by his/herself in <10 secondes, and requires help for such movement
- The patient has a sitting-balance score > 2/4 (Brun et al 1991: Actual Rééduc Réadaptat: (16):412-7))
Key exclusion criteria (10 listed)
- 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 has fractured vertebrae or pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitting upThe patient is positioned on a Winncare type bed dressed with a pressure-sensor sheet and equipped with either a hanging triangle bar (supporting arm of the bar is adjusted to 30 degrees) or an ERGONOME device according to randomization. The patient is first installed on the bed in a strictly supine position, the pelvis centered, and the greater trochanter over the fold of the backrest. The investigator then gives instructions on how to use the randomized device (correct hand placement). The patient is asked to sit up twice (two consecutive attempts). The first attempt is a learning attempt. The observations necessary for this study will be taken on the second attempt. Thus the second sitting attempt is timed, video-taped and recorded via the pressure-sensor sheet beneath the patient. | Other | Ergonome, Hanging Triangle Bar |
Primary outcome
Successful transition from a laying position to a sitting position
Time frame: Baseline (day 0)
yes/no
2 secondary outcomes
Time needed to sit up
Time frame: baseline (day 0)
Shift in the patient's center of mass (cm)
Time frame: baseline (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Viollet, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting up in people with Supine Position and Elderly, 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 10 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?
Successful transition from a laying position to a sitting position (time frame: Baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.