A Very Early Standing Study in Elderly Stroke

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Procedure: Verticalization

• Registration Number: NCT03424031
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-31
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-06
• Primary Completion: 2020-07-10
• Study Completion: 2020-07-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verticalization	Verticalization	the patient will be placed in the most vertical position possible.

Primary Outcome Measures

Name	Time	Method
PASS score	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of days with stools	Day 15	Number of days with stool / number of days of hospitalization in UNV
functional recovery	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	Month 4	It will be performed in single blind thanks to the modified FAC scale at 4 month
Semi-quantitative evaluation	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)

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France