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

This study is currently recruiting participants.
Verified February 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01520636
First received: January 18, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Rehabilitation
Procedure: standard physiotherapy
Procedure: experimental physiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: What Should be the Best Physiotherapy Early After Stroke ?

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK [ Time Frame: between day 0 and month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor control deficiency assessed by the FM scale [ Time Frame: at D15, D30, D45, M3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to D30 ] [ Designated as safety issue: No ]
    Total length of stay as inpatient

  • Autonomy assessed by the Functional Independence Measure (motor subscale) [ Time Frame: at D30 and M3 ] [ Designated as safety issue: No ]
  • Autonomy assessed by the Rankin scale [ Time Frame: at D15, D30, D45, M3. ] [ Designated as safety issue: No ]
  • Unexpected events [ Time Frame: at D30 and M3 ] [ Designated as safety issue: No ]
    Unexpected events recorded on D30 and M3

  • Quality of life assessed by the Stroke Impact Scale [ Time Frame: at M3 ] [ Designated as safety issue: No ]
    Quality of life assessed by the Stroke Impact Scale on M3

  • Residency [ Time Frame: at M3 ] [ Designated as safety issue: No ]
  • Scale PASS [ Time Frame: at D30 and M3 ] [ Designated as safety issue: No ]
    Evaluation scale of balance PASS at D30 and M3


Estimated Enrollment: 400
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: group 1: standard physiotherapy
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.
Procedure: standard physiotherapy
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
Experimental: group 2: experimental physiotherapy
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.
Procedure: experimental physiotherapy
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Control motor deficiency at least as severe the inability to stand up.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520636

Contacts
Contact: Alain YELNIK, MD,PhD 33 (0)1 40 05 42 05 alain.yelnik@lrb.aphp.fr

Locations
France
Service de MPR - Hôpital Fernand Widal Not yet recruiting
Paris, France, 75010
Principal Investigator: Alain YELNIK, MD, PhD         
Service de Neurologie - Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Jérôme Mawet, MD    33 149956512    jerome.mawet@lrb.aphp.fr   
Principal Investigator: Jerôme Mawet, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Alain YELNIK, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01520636     History of Changes
Other Study ID Numbers: P100124, 2011-A01049-32
Study First Received: January 18, 2012
Last Updated: February 19, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
stroke
early rehabilitation
motor recovery
functional recovery

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014