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A Very Early Standing Study in Elderly Stroke (AVESSES)

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Verticalization
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHR d'Orléans

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Verticalization

Passive mobilization

Arm Description

the patient will be placed in the most vertical position possible.

Passive mobilization of the lower limb deficit

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Evaluation of the walk quality
It will be performed in single blind thanks to the modified FAC scale at 4 month
Percentage of days with stools
Number of days with stool / number of days of hospitalization in UNV
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)

Full Information

First Posted
January 15, 2018
Last Updated
November 5, 2020
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03424031
Brief Title
A Very Early Standing Study in Elderly Stroke
Acronym
AVESSES
Official Title
A Very Early Standing Study in Elderly Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
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).
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
July 10, 2020 (Actual)
Study Completion Date
July 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verticalization
Arm Type
Experimental
Arm Description
the patient will be placed in the most vertical position possible.
Arm Title
Passive mobilization
Arm Type
No Intervention
Arm Description
Passive mobilization of the lower limb deficit
Intervention Type
Procedure
Intervention Name(s)
Verticalization
Intervention Description
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.
Primary Outcome Measure Information:
Title
PASS score
Description
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).
Time Frame
4th month
Secondary Outcome Measure Information:
Title
functional recovery
Description
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.
Time Frame
Day 15
Title
Evaluation of the walk quality
Description
It will be performed in single blind thanks to the modified FAC scale at 4 month
Time Frame
Month 4
Title
Percentage of days with stools
Description
Number of days with stool / number of days of hospitalization in UNV
Time Frame
Day 15
Title
Semi-quantitative evaluation
Description
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)
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canan OZSANCAK, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17702703
Citation
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.
Results Reference
background
PubMed Identifier
11779908
Citation
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.
Results Reference
background
PubMed Identifier
15929503
Citation
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.
Results Reference
background
PubMed Identifier
10471437
Citation
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.
Results Reference
background

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A Very Early Standing Study in Elderly Stroke

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