Very Early Rehabilitation or Intensive Telemetry after Stroke: A Pilot Randomised Trial

Background: Stroke patients are more likely to make a good recovery if they receive care in a well-organised stroke unit. However, there are uncertainties about how best to provide such care. We studied 2 key aspects of early stroke unit care: early active mobilisation (EM) and automated monitoring(AM) for physiological complications such as hypoxia. Methods: This was an observer-blinded, factorial (2 ! 2) pilot randomised controlled trial recruiting stroke patients within 36 h of symptom onset. The patients were randomised to 1 of 4 nurse-led treatment protocols: (a) standard stroke unit care, (b) EM, (c) AM or (d) combined EM and AM. The primary outcome was the Rankin score at 3 months. We also report the data on feasibility and safety. Results: We randomised 32 patients (mean age = 65 years; mean baseline modified NIH score = 6). On unadjusted comparisons, the EM patients were significantly (p ! 0.05) more likely to mobilise very early (within 1 h of randomisation) and to achieve walking by day 5 and were less likely to develop complications of immobility. The AM group was significantly (p ! 0.05) more likely to have pre-defined physiological complication events detected. All these associations remained, but were less statistically significant, after correcting for age, baseline NIH score and co-interventions. There were no significant safety concerns. Discussion: We have demonstrated the feasibility of implementing EM and AM for physiological complications in a randomised controlled trial. Larger trials are warranted to determine whether these interventions have clinical benefits