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 >= 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. 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.