Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS).

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, 0-5) and the Barthel Index (0-100), 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 > or = 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 B < 0.0001) at treatment end. Also, significantly more group A patients had reached a Barthel Index > or = 75: 44 of 77 versus 21 of 78 (P B < 0.0001). At six-month follow-up, the superior gait ability in group A persisted (54 of 77 versus 28 of 78, P B < 0.0001), while the Barthel Index responder rate did not differ. For all secondary variables, group A patients had improved significantly more (P B < 0.0001) during the treatment period, but not during follow-up. CONCLUSIONS Intensive locomotor training plus physiotherapy resulted in a significantly better gait ability and daily living competence in subacute stroke patients compared with physiotherapy alone.