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

What Should be the Best Physiotherapy Early After Stroke ?

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01520636
Acronym
AMOBES
Enrollment
104
Registered
2012-01-30
Start date
2012-07-31
Completion date
2015-12-31
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation

Keywords

stroke, early rehabilitation, motor recovery, functional recovery

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.

Interventions

PROCEDUREstandard 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

PROCEDUREexperimental 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.

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARKbetween day 0 and month 3

Secondary

MeasureTime frameDescription
Total length of stay as inpatientup to D30Total length of stay as inpatient
Autonomy assessed by the Functional Independence Measure (motor subscale)at D30 and M3
Autonomy assessed by the Rankin scaleat D15, D30, D45, M3.
Motor control deficiency assessed by the FM scaleat D15, D30, D45, M3Motor 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.
Quality of life assessed by the Stroke Impact Scaleat M3Quality of life assessed by the Stroke Impact Scale on M3
Residencyat M3
Scale PASSat D30 and M3Evaluation scale of balance PASS at D30 and M3
Unexpected eventsat D30 and M3Unexpected events recorded on D30 and M3

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026