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

Rehabilitation Clinical Trial

— AMOBES  

Official title:

What Should be the Best Physiotherapy Early After Stroke ?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01520636
• Other study ID #: P100124
• Secondary ID: 2011-A01049-32
• Status: Terminated
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rehabilitation
• Stroke

Intervention

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 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.

Locations

Country	Name	City	State
France	Service de MPR - Hôpital Fernand Widal	Paris
France	Service de Neurologie - Hôpital Lariboisière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK		between day 0 and month 3
Secondary	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
Secondary	Total length of stay as inpatient	Total length of stay as inpatient	up to D30
Secondary	Autonomy assessed by the Functional Independence Measure (motor subscale)		at D30 and M3
Secondary	Autonomy assessed by the Rankin scale		at D15, D30, D45, M3.
Secondary	Unexpected events	Unexpected events recorded on D30 and M3	at D30 and M3
Secondary	Quality of life assessed by the Stroke Impact Scale	Quality of life assessed by the Stroke Impact Scale on M3	at M3
Secondary	Residency		at M3
Secondary	Scale PASS	Evaluation scale of balance PASS at D30 and M3	at D30 and M3