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

NCT ID: NCT01520636

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

standard physiotherapy

Intervention Type: PROCEDURE

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: 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.

Group Type: EXPERIMENTAL

experimental physiotherapy

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain YELNIK, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de MPR - Hôpital Fernand Widal

Paris, , France

Service de Neurologie - Hôpital Lariboisière

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 28008092 (View on PubMed)

Other Identifiers

2011-A01049-32

Identifier Type: OTHER

Identifier Source: secondary_id

P100124

Identifier Type: -

Identifier Source: org_study_id