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

What Should be the Best Physiotherapy Early After Stroke ?

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.

Study Overview

• Status: Terminated
• Conditions: Rehabilitation
• Intervention / Treatment: Procedure: standard physiotherapy; Procedure: experimental physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Service de MPR - Hôpital Fernand Widal
  • Paris, France, 75010
    • Service de Neurologie - Hôpital Lariboisière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK	between day 0 and month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at D15, D30, D45, M3
Total length of stay as inpatient	Total length of stay as inpatient	up to D30
Autonomy assessed by the Functional Independence Measure (motor subscale)		at D30 and M3
Autonomy assessed by the Rankin scale		at D15, D30, D45, M3.
Unexpected events	Unexpected events recorded on D30 and M3	at D30 and M3
Quality of life assessed by the Stroke Impact Scale	Quality of life assessed by the Stroke Impact Scale on M3	at M3
Residency		at M3
Scale PASS	Evaluation scale of balance PASS at D30 and M3	at D30 and M3

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Alain YELNIK, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: stroke; functional recovery; early rehabilitation; motor recovery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: P100124; 2011-A01049-32 (Other Identifier: IDRCB)