Active mobility early after stroke. A randomised controled trial (AMOBES).

OBJECTIVE: Active and intensive physical therapy (PT) facilitates motor recovery when provided at a subacute stage after stroke. The efficiency of very early intensive PT (within the 2 first weeks) has been much less investigated. Early intensive rehabilitation might be beneficial for neural plasticity but also detrimental by worsening the cerebral ischemia. The AVERT study (Bernhardt 2015) showed negative effect of high dose of very early mobilisation.

MATERIAL/PATIENTS AND METHODS: Patients have been recruited in this multicentre randomized controlled trial (9 stroke units with PRM teams) to compare "soft" (20 min/day apart from respiratory needs) versus "intensive" PT (idem+45 minutes of intensive exercises/day), initiated within the 72 first hours after a first hemispheric stroke. Blind assessment has been made. The primary criterion was the motor control assessed by the Fugl Meyer score at D90. Secondary criteria were: Fugl Meyer at D15, D30, D45, postural balance (postural assessment scale for stroke), autonomy (rankin and functional independence measure) at D15, D30, D45, D90, unexpected medical events, length of hospital stay, quality of life (stroke impact scale) at D90. The study has been approved by the local ethics committee n(o) 2011/37, registered on clinical trial.gov NCT01520636.

RESULTS: One hundred and three of the 104 included patients could be analysed, 64 males, 67 right hemispheric lesions, 80 ischemic lesions, NIHSS<8 in 19 patients, 8-15 in 42, >15 in 42; age 66.2±13/67.2±11. No significant difference between groups was observed for the primary criterion (median: 41.5 [14;76] versus 54 [22;80], p=0.32), neither for any of the secondary criteria. The number of unexpected medical events was the same in the two groups. The sub-group analysis, for the primary as for the secondary criteria, according to the 3 groups of severity, the side of the lesion, thrombolysis, or type of stroke did not show any difference.

DISCUSSION - CONCLUSION: The results of the RCT (AMOBES) confirm previous studies. Very early intensive exercises after stroke are not more effective on motor recovery than a soft PT preventing immobility related complications.