OBJECTIVE: To compare the efficacy of gait training using a single-leg version of the hybrid assistive limb (HAL) on the paretic side to conventional gait training in individuals with subacute stroke. DESIGN: Randomized open controlled pilot trial SETTING: Hospitalized care in a recovery phase rehabilitation ward PARTICIPANTS: Convenience sample. Of 44 patients who met the criteria for this study, 12 patients refused. After randomization, 10 patients withdrew and a total of 22 poststroke participants (HAL group: n = 11, conventional group: n = 11) completed the randomized clinical trial. INTERVENTIONS: All participants received twelve 20-minute sessions in 4 weeks of either HAL (wearing the single-leg version of HAL on their paretic side) or conventional (performed by skilled and experienced physical therapists) gait training. MAIN OUTCOME MEASURES: Outcome measures were evaluated prior to training and after 12 sessions. Functional Ambulation Category (FAC) was the primary outcome measure, while secondary outcome measures included maximum walking speed, timed up-and-go test, 6-minute walk distance, Short Physical Performance Battery, Fugl-Meyer assessment of lower extremity, and isometric muscle strength (hip flexion and extension, knee flexion and extension). RESULTS: No participants withdrew due to adverse effects. Participants who received gait training with HAL showed significantly more improvement in FAC than those who received conventional gait training (95% confidence interval 0.02 to 0.88; p = 0.04). Secondary measures did not differ between the 2 groups. CONCLUSIONS: The results obtained in this randomized controlled trial suggest that a gait training program with HAL could improve independent walking more efficiently than conventional gait training.

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