A Very Early Standing Study in Elderly Stroke (AVESSES)

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 Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Procedure: Verticalization

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45067
    • CHR d'Orléans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verticalization; the patient will be placed in the most vertical position possible.	Procedure: Verticalization; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Canan OZSANCAK, Dr, CHR d'Orléans

Publications and helpful links

General 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.
• Bagg 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.
• Bagley 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.
• Benaim 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2017
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CHRO-2016-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No