A Very Early Standing Study in Elderly Stroke

Study Overview
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Brief Summary
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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.

Official Title
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A Very Early Standing Study in Elderly Stroke

Conditions
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Stroke

Intervention / Treatment
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* Procedure: Verticalization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verticalization<br>the patient will be placed in the most vertical position possible. | Procedure: Verticalization<br>* 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.<br>|
| No Intervention: Passive mobilization<br>Passive mobilization of the lower limb deficit | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 4th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 15 | 
| Evaluation of the walk quality | It will be performed in single blind thanks to the modified FAC scale at 4 month | Month 4 | 
| Percentage of days with stools | Number of days with stool / number of days of hospitalization in UNV | 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) | Day 15 |