A Very Early Standing Study in Elderly Stroke (AVESSES)
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|ClinicalTrials.gov Identifier: NCT03424031|
Recruitment Status : Terminated (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).)
First Posted : February 6, 2018
Last Update Posted : November 6, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Procedure: Verticalization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||A Very Early Standing Study in Elderly Stroke|
|Actual Study Start Date :||January 31, 2017|
|Actual Primary Completion Date :||July 10, 2020|
|Actual Study Completion Date :||July 10, 2020|
the patient will be placed in the most vertical position possible.
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.
No Intervention: Passive mobilization
Passive mobilization of the lower limb deficit
- 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).
- functional recovery [ Time Frame: Day 15 ]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.
- Evaluation of the walk quality [ Time Frame: Month 4 ]It will be performed in single blind thanks to the modified FAC scale at 4 month
- Percentage of days with stools [ Time Frame: Day 15 ]Number of days with stool / number of days of hospitalization in UNV
- Semi-quantitative evaluation [ Time Frame: Day 15 ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424031
|Orléans, France, 45067|
|Principal Investigator:||Canan OZSANCAK, Dr||CHR d'Orléans|