Gait training in subacute non-ambulatory stroke patients using a full weight-bearing gait-assistance robot: A prospective, randomized, open, blinded-endpoint trial

Abstract Background This study was a prospective, randomized, open, blinded-endpoint trial with the aim of examining whether gait training with a gait-assistance robot (GAR) improves gait disturbances in subacute non-ambulatory hemiplegic stroke patients more than overground conventional gait training. The GAR adopts a robot arm control system with full weight bearing and foot pressure visual biofeedback. Methods Twenty-six hemiplegic patients were randomly assigned to either the GAR-assisted gait training (GAGT) group or the overground conventional gait training (OCGT) group. Both groups underwent 60 min of standard physical therapy and 20 min of GAGT or OCGT 5 days a week for 4 weeks. The primary outcome measure was the Functional Ambulation Classification (FAC). The secondary outcome measures were the peak torque of the extensor muscles in the lower extremities and a 10-m walking test. The lower extremity function was evaluated using the Fugl-Meyer Assessment, and activities of daily living were assessed using the Functional Independence Measure. Results The GAGT group demonstrated significantly greater improvements in FAC and peak torque on the unaffected side ( p = 0.02) than the OCGT group. Additionally, gait speed tended to be faster ( p = 0.07) in the GAGT group. Conclusions GAGT combined with standard physical therapy in subacute non-ambulatory hemiplegic patients led to significant improvements in gait and peak torque on the unaffected side compared to OCGT.