Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Very Early Standing Study in Elderly Stroke (AVESSES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Stroke Procedure: Verticalization Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Percentage of days with stools [ Time Frame: Day 15 ]
    Number of days with stool / number of days of hospitalization in UNV

  4. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
France
CHR d'Orléans
Orléans, France, 45067
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
Layout table for investigator information
Principal Investigator: Canan OZSANCAK, Dr CHR d'Orléans
Publications:
Layout table for additonal information
Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT03424031    
Other Study ID Numbers: CHRO-2016-02
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases