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Active MOBility Early After Stroke : What Should be the Best Physiotherapy Early After Stroke ? (AMOBES)

Primary Purpose

Rehabilitation

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standard physiotherapy
experimental physiotherapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation focused on measuring stroke, early rehabilitation, motor recovery, functional recovery

Eligibility Criteria

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

Inclusion Criteria:

  • Patients informed and giving their written consent.First
  • Ever ischemic hemispheric or haemorrhagic stroke, unilateral, occurred between the 25th and the 72nd previous hours
  • Age ≥ 18 years old
  • Motricity quoted by an NIHSS >=2 in the upper limb or in the lower limb

Exclusion Criteria:

  • Patient without health insurance.
  • Coma (NIHSS consciousness > or = 2)
  • Total recovery within the 24 first hours
  • Brain stem or cerebellar stroke
  • Previous neurological history, specially stroke or dementia
  • Inability to understand the study
  • Surgical treatment of the stroke
  • Autonomy before stroke assessed by Rankin score different from 0
  • Scheduled surgery in the following 15 days

Sites / Locations

  • Service de MPR - Hôpital Fernand Widal
  • Service de Neurologie - Hôpital Lariboisière

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

group 1: standard physiotherapy

group 2: experimental physiotherapy

Arm Description

daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day.

physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day.

Outcomes

Primary Outcome Measures

Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK

Secondary Outcome Measures

Motor control deficiency assessed by the FM scale
Motor control deficiency assessed by the FM scale on D15, D30, D45, M3 and by the time requested before being able to walk 10 meters without human assistance.
Total length of stay as inpatient
Total length of stay as inpatient
Autonomy assessed by the Functional Independence Measure (motor subscale)
Autonomy assessed by the Rankin scale
Unexpected events
Unexpected events recorded on D30 and M3
Quality of life assessed by the Stroke Impact Scale
Quality of life assessed by the Stroke Impact Scale on M3
Residency
Scale PASS
Evaluation scale of balance PASS at D30 and M3

Full Information

First Posted
January 18, 2012
Last Updated
January 17, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01520636
Brief Title
Active MOBility Early After Stroke : What Should be the Best Physiotherapy Early After Stroke ?
Acronym
AMOBES
Official Title
What Should be the Best Physiotherapy Early After Stroke ?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
difficulty of inclusion
Study Start Date
July 2012 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.
Detailed Description
Hypothesis: An intensive and active physiotherapy delivered as soon as D2 post stroke could induce faster motor control recovery and autonomy than could do an usual conservative treatment aiming at preventing complications. The benefits could be a shortened inpatient stay (both in stroke unit and rehabilitation centre), a reduction of the secondary complications with a cut in of the total cost of care. Primary objective: To compare two strategies of physiotherapy on the evolution of motor control recovery during the first 3 months post stroke. Secondary objectives : To compare two strategies of physiotherapy on: Motor control deficiency on D15, D30, D45, M3 Total length of stay as inpatient Autonomy on D15, D30, D45, M3 Frequency of unexpected events Quality of life on M3 Living place on M3 Assessment criteria: -First criterion : Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK between day 0 and month 3.-Secondary criteria : Motor control deficiency assessed by the FM scale on D15, D30, D45, M3 and by the time requested before being able to walk 10 meters without human assistance. Total length of stay as inpatient Autonomy assessed by the Functional Independence Measure (motor subscale) on D30 and M3 and by the Rankin scale on D15, D30, D45, M3. Unexpected events recorded on D30 and M3 Quality of life assessed by the Stroke Impact Scale on M3 Residency Method: This is a "Zelen", single-blinded, randomised, controlled, multicentric trial aiming at comparing intensive physiotherapy after a stroke with the usually more conservative physiotherapy provided. Treatment is applied from the inclusion to the end of the stroke unit stay or until D15 post stroke. Group 1: daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day. Group 2: physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation
Keywords
stroke, early rehabilitation, motor recovery, functional recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1: standard physiotherapy
Arm Type
Placebo Comparator
Arm Description
daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day.
Arm Title
group 2: experimental physiotherapy
Arm Type
Experimental
Arm Description
physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day.
Intervention Type
Procedure
Intervention Name(s)
standard physiotherapy
Intervention Description
daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day
Intervention Type
Procedure
Intervention Name(s)
experimental physiotherapy
Intervention Description
physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day.
Primary Outcome Measure Information:
Title
Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK
Time Frame
between day 0 and month 3
Secondary Outcome Measure Information:
Title
Motor control deficiency assessed by the FM scale
Description
Motor control deficiency assessed by the FM scale on D15, D30, D45, M3 and by the time requested before being able to walk 10 meters without human assistance.
Time Frame
at D15, D30, D45, M3
Title
Total length of stay as inpatient
Description
Total length of stay as inpatient
Time Frame
up to D30
Title
Autonomy assessed by the Functional Independence Measure (motor subscale)
Time Frame
at D30 and M3
Title
Autonomy assessed by the Rankin scale
Time Frame
at D15, D30, D45, M3.
Title
Unexpected events
Description
Unexpected events recorded on D30 and M3
Time Frame
at D30 and M3
Title
Quality of life assessed by the Stroke Impact Scale
Description
Quality of life assessed by the Stroke Impact Scale on M3
Time Frame
at M3
Title
Residency
Time Frame
at M3
Title
Scale PASS
Description
Evaluation scale of balance PASS at D30 and M3
Time Frame
at D30 and M3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients informed and giving their written consent.First Ever ischemic hemispheric or haemorrhagic stroke, unilateral, occurred between the 25th and the 72nd previous hours Age ≥ 18 years old Motricity quoted by an NIHSS >=2 in the upper limb or in the lower limb Exclusion Criteria: Patient without health insurance. Coma (NIHSS consciousness > or = 2) Total recovery within the 24 first hours Brain stem or cerebellar stroke Previous neurological history, specially stroke or dementia Inability to understand the study Surgical treatment of the stroke Autonomy before stroke assessed by Rankin score different from 0 Scheduled surgery in the following 15 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain YELNIK, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de MPR - Hôpital Fernand Widal
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Service de Neurologie - Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28008092
Citation
Yelnik AP, Quintaine V, Andriantsifanetra C, Wannepain M, Reiner P, Marnef H, Evrard M, Meseguer E, Devailly JP, Lozano M, Lamy C, Colle F, Vicaut E; AMOBES Group. AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial. Stroke. 2017 Feb;48(2):400-405. doi: 10.1161/STROKEAHA.116.014803. Epub 2016 Dec 22.
Results Reference
result

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Active MOBility Early After Stroke : What Should be the Best Physiotherapy Early After Stroke ?

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