StrokeAVESSESNCT03424031
A Very Early Standing Study in Elderly Stroke
A study testing Verticalization in people with Stroke, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Functional recovery is one of the main issues in the management of stroke and there are various ways in rehabilitation to promote this recovery. Verticalization is a technique whose benefits have been widely demonstrated, particularly in neurology. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Verticalization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2017to 10 Jul 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke
- Age > 70
- Modified Rankin Scale (MRS) pre stroke : 0 or 1
- Admission in the neuro vascular unit less than 48 hours after the onset of symptoms
- NIHSS Item 6 for lower extremity motor skills: 3 or 4
- Modified Functional Ambulation Classification : 0
- Affiliated to a social security scheme
Who cannot join
- History of stroke with motor sequencing limiting walking
- Arterial stenosis limiting the sunrise before D4 (identified by Doppler)
- Symptomatic orthostatic hypotension known or present in the acute phase
- Coma
- Patients who will be referred to a structure (UNV or other) outside the department
- Fracture, orthopedic disorder or any other complication preventing verticalization
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- Refusal of the patient to participate in the study or to be verticalized
- Patients under guardianship
- Patients deprived of their liberty by an administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Functional recovery is one of the main issues in the management of stroke and there are various ways in rehabilitation to promote this recovery.
Verticalization is a technique whose benefits have been widely demonstrated, particularly in neurology. Although commonly used in the rehabilitation of stroke, evidence is still lacking as to its impact in this specific care.
Read more
Verticalization is underutilized in two situations: in the hyper acute phase as well as in elderly and very deficient patients. It has, however, been shown that the precocity of the treatment allows a better functional recovery. Similarly, the re-education of the elderly is also debated since it has long been mentioned that age was a factor of poor prognosis, the objectives are sometimes underestimated. However, several studies have shown that with the same rehabilitation, elderly patients recover as much as younger patients. The differences found are at least in part due to "less rehabilitation" of older stroke patients.
The different existing data lead us to the hypothesis that the verticalization of the elderly hemiplegic patient in acute phase would allow a better functional recovery.
- Conditions
- Stroke
- Being tested
- Verticalization
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerticalizationProcedure or surgery
To allow the verticalization of hemiplegic patients, we will use a device commonly used in rehabilitation: the standing (or standing) brand Thera Trainer . This device makes it possible to keep the patient standing despite the motor and postural deficits thanks to knee, buttocks and an anterior support for the upper limbs. Verticalization with this device requires the presence of one or two caregivers (including at least one re-educator), depending on the possibilities of participation of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Verticalization | Experimental | the patient will be placed in the most vertical position possible. Receives: Procedure: Verticalization |
| Passive mobilization | No intervention | Passive mobilization of the lower limb deficit |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASS score
the PASS score (score of 36) will be evaluated at 4 months (t2) in single blind (by a physiotherapist who will not be aware of the reeducation performed).
Measured: 4th month
Secondary outcomes (4)
functional recovery
It will be performed in single blind by evaluating the PASS score after the 10th session (t1) or when the patient leaves if it occurs before.
Measured: Day 15
Evaluation of the walk quality
It will be performed in single blind thanks to the modified FAC scale at 4 month
Measured: Month 4
Percentage of days with stools
Number of days with stool / number of days of hospitalization in UNV
Measured: Day 15
Semi-quantitative evaluation
The amount of stool is evaluated in the data collection of the care teams (0: no saddle, +: small amount of stool, ++: moderate amount, +++: larger quantity, ++ ++: very important quantity)
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start31 Jan 2017
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Why it stopped: Many study exits (many deaths, aggravations) that we had anticipated (but not enough). The patients did not stay long enough in the department to complete the protocol (many study exits that we had not anticipated).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan OZSANCAK, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424031
- Sponsor's protocol ID
- CHRO-2016-02
- Acronym
- AVESSES
- Status last verified
- Nov 2020
- First submitted
- 15 Jan 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allison R, Dennett R. Pilot randomized controlled trial to assess the impact of additional supported standing practice on functional ability post stroke. Clin Rehabil. 2007 Jul;21(7):614-9. doi: 10.1177/0269215507077364.
PubMed 17702703Bagg S, Pombo AP, Hopman W. Effect of age on functional outcomes after stroke rehabilitation. Stroke. 2002 Jan;33(1):179-85. doi: 10.1161/hs0102.101224.
PubMed 11779908Bagley P, Hudson M, Forster A, Smith J, Young J. A randomized trial evaluation of the Oswestry Standing Frame for patients after stroke. Clin Rehabil. 2005 Jun;19(4):354-64. doi: 10.1191/0269215505cr874oa.
PubMed 15929503Benaim C, Perennou DA, Villy J, Rousseaux M, Pelissier JY. Validation of a standardized assessment of postural control in stroke patients: the Postural Assessment Scale for Stroke Patients (PASS). Stroke. 1999 Sep;30(9):1862-8. doi: 10.1161/01.str.30.9.1862.
PubMed 10471437
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Very Early Standing Study in Elderly Stroke
- ClinicalTrials.gov ID
- NCT03424031
- Acronym / sponsor ID
- AVESSES / CHRO-2016-02
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Many study exits (many deaths, aggravations) that we had anticipated (but not enough). The patients did not stay long enough in the department to complete the protocol (many study exits that we had not anticipated).
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 6 Feb 2018 (actual)
- 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.
Functional recovery is one of the main issues in the management of stroke and there are various ways in rehabilitation to promote this recovery.
Verticalization is a technique whose benefits have been widely demonstrated, particularly in neurology. Although commonly used in the rehabilitation of stroke, evidence is still lacking as to its impact in this specific care.
Verticalization is underutilized in two situations: in the hyper acute phase as well as in elderly and very deficient patients. It has, however, been shown that the precocity of the treatment allows a better functional recovery. Similarly, the re-education of the elderly is also debated since it has long been mentioned that age was a factor of poor prognosis, the objectives are sometimes underestimated. However, several studies have shown that with the same rehabilitation, elderly patients recover as much as younger patients. The differences found are at least in part due to "less rehabilitation" of older stroke patients.
The different existing data lead us to the hypothesis that the verticalization of the elderly hemiplegic patient in acute phase would allow a better functional recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verticalization | Experimental | Procedure: Verticalizationthe patient will be placed in the most vertical position possible. |
| Passive mobilization | No intervention | –Passive mobilization of the lower limb deficit |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Ischemic or hemorrhagic stroke
- Age > 70
- Modified Rankin Scale (MRS) pre stroke : 0 or 1
- Admission in the neuro vascular unit less than 48 hours after the onset of symptoms
- NIHSS Item 6 for lower extremity motor skills: 3 or 4
Key exclusion criteria (9 listed)
- History of stroke with motor sequencing limiting walking
- Arterial stenosis limiting the sunrise before D4 (identified by Doppler)
- Symptomatic orthostatic hypotension known or present in the acute phase
- Coma
- Patients who will be referred to a structure (UNV or other) outside the department
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 |
|---|---|---|
| VerticalizationTo allow the verticalization of hemiplegic patients, we will use a device commonly used in rehabilitation: the standing (or standing) brand Thera Trainer . This device makes it possible to keep the patient standing despite the motor and postural deficits thanks to knee, buttocks and an anterior support for the upper limbs. Verticalization with this device requires the presence of one or two caregivers (including at least one re-educator), depending on the possibilities of participation of the patient. | Procedure or surgery | Verticalization |
Primary outcome
PASS score
Time frame: 4th month
the PASS score (score of 36) will be evaluated at 4 months (t2) in single blind (by a physiotherapist who will not be aware of the reeducation performed).
4 secondary outcomes
functional recovery
Time frame: Day 15
Evaluation of the walk quality
Time frame: Month 4
Percentage of days with stools
Time frame: Day 15
Semi-quantitative evaluation
Time frame: Day 15
Results and safety
The study was stopped early (reason given: Many study exits (many deaths, aggravations) that we had anticipated (but not enough). The patients did not stay long enough in the department to complete the protocol (many study exits that we had not anticipated).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 17702703Allison R, Dennett R. Pilot randomized controlled trial to assess the impact of additional supported standing practice on functional ability post stroke. Clin Rehabil. 2007 Jul;21(7):614-9. doi: 10.1177/0269215507077364.
- Background: PubMed 11779908Bagg S, Pombo AP, Hopman W. Effect of age on functional outcomes after stroke rehabilitation. Stroke. 2002 Jan;33(1):179-85. doi: 10.1161/hs0102.101224.
- Background: PubMed 15929503Bagley P, Hudson M, Forster A, Smith J, Young J. A randomized trial evaluation of the Oswestry Standing Frame for patients after stroke. Clin Rehabil. 2005 Jun;19(4):354-64. doi: 10.1191/0269215505cr874oa.
- Background: PubMed 10471437Benaim C, Perennou DA, Villy J, Rousseaux M, Pelissier JY. Validation of a standardized assessment of postural control in stroke patients: the Postural Assessment Scale for Stroke Patients (PASS). Stroke. 1999 Sep;30(9):1862-8. doi: 10.1161/01.str.30.9.1862.
- Individual participant dataSharing planned: No
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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.
Canan OZSANCAK, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verticalization in people with Stroke, run by Centre Hospitalier Régional d'Orléans 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Nov 2020. 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 was stopped early (reason given: Many study exits (many deaths, aggravations) that we had anticipated (but not enough). The patients did not stay long enough in the department to complete the protocol (many study exits that we had not anticipated).). Results are not available in the source record.
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?
PASS score (time frame: 4th month). 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 NCT03424031, which also lists 4 linked publications.
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 6 Nov 2020.