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

Not Applicable

Terminated

• Conditions: Rehabilitation
• Interventions: Procedure: standard physiotherapy; Procedure: experimental physiotherapy

• Registration Number: NCT01520636
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-30
• Study Start: 2012-07
• Primary Completion: 2015-03
• Study Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1: standard physiotherapy	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 2: experimental physiotherapy	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Service de Neurologie - Hôpital Lariboisière; 🇫🇷 Paris, France

Service de MPR - Hôpital Fernand Widal; 🇫🇷 Paris, France