OBJECTIVE: To evaluate the effect of repetitive locomotor training on an electromechanical gait trainer plus physiotherapy in subacute stroke patients. DESIGN: Randomized controlled trial. SETTING: Four German neurological rehabilitation centres. SUBJECTS: One hundred and fifty-five non-ambulatory patients (first-time stroke < 60 days). INTERVENTION: Group A received 20 min locomotor training and 25 min physiotherapy; group B had 45 min physiotherapy every week day for four weeks. MAIN OUTCOME MEASURES: Primary variables were gait ability (Functional Ambulation Category, 0 to 5) and the Barthel Index (0 to 100), blindly assessed at study onset, end, and six months later for follow-up. Responders to the therapy had to become ambulatory (Functional Ambulation Category 4 or 5) or reach a Barthel Index of >= 75. Secondary variables were walking velocity, endurance, mobility and leg power. RESULTS: The intention-to-treat analysis revealed that significantly greater number of patients in group A could walk independently: 41 of 77 versus 17 of 78 in group B (p < 0.0001) at treatment end. Also, significantly more group A patients had reached a Barthel Index >= 75: 44 of 77 versus 21 of 78 (p < 0.0001). At six-month follow-up, the superior gait ability in group A persisted (54 of 77 versus 28 of 78, p < 0.0001), while the Barthel Index responder rate did not differ. For all secondary variables, group A patients had improved significantly more (p < 0.0001) during the treatment period, but not during follow-up. CONCLSUSIONS: Intensive locomotor training plus physiotherapy resulted in a significantly better gait ability and daily living competence in subacute stroke patients compared with physiotherapy alone.

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