AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial.

BACKGROUND AND PURPOSE:Intensive physical therapy (PT) facilitates motor recovery when provided during a subacute stage after stroke. The efficiency of very early intensive PT has been less investigated. We aimed to investigate whether intensive PT conducted within the first 2 weeks could aid recovery of motor control. METHODS:This multicentre randomized controlled trial compared soft PT (20-min/d apart from respiratory needs) and intensive PT (idem+45 minutes of intensive exercises/day) initiated within the first 72 hours after a first hemispheric stroke. The primary outcome was change in motor control between day (D) 90 and D0 assessed by the Fugl-Meyer score. Main secondary outcomes were number of days to walking 10 m unassisted, balance, autonomy, quality of life, and unexpected medical events. All analyses were by intent to treat. RESULTS:We could analyze data for 103 of the 104 included patients (51 control and 52 experimental group; 64 males; median age overall 67 [interquartile range 59-77], 67 right hemispheric lesions, 80 ischemic lesions, National Institutes of Health Stroke Scale score ≥8 for 82%). Fugl-Meyer score increased over time (P<0.0001), with no significant effect of treatment (P=0.29) or interaction between treatment and time (P=0.40). The median change in score between D90 and D0 was 27.5 (12-40) and 22.0 (12-56) for control and experimental groups (P=0.69). Similar results were found for the secondary criteria. CONCLUSIONS:Very early after stroke, intensive exercises may not be efficient in improving motor control. This conclusion may apply to mainly severe stroke. CLINICAL TRIAL REGISTRATION:URL: http://www.clinicaltrials.gov. Unique identifier: NCT01520636.