OBJECTIVE: Robot-aided exercise therapy is a promising approach to enhance walking ability in stroke survivors. This study was designed to test a new robotic knee brace for restoring mobility in stroke survivors. DESIGN: Twenty-four ambulatory individuals with chronic hemiparesis after stroke were enrolled in this pilot study. The participants were randomly assigned in equal numbers to either treatment with the experimental device or to a group exercise program and received a total of 18 hrs of their assigned therapy during a 6-wk training period. The primary outcome was gait velocity, as measured with the 10-m walk test. Secondary measures included 6-min walk test, Timed Up and Go test, Five-Times-Sit-to-Stand test, Romberg test, Emory Functional Ambulation Profile, Berg Balance scale, and the California Functional Evaluation 40. RESULTS: Twenty subjects completed the entire protocol and all follow-up visits. No significant differences between the two groups were found for the primary outcome measure at either the completion of training (week 6) or at the 3-mo follow-up (week 19), with inconsistent findings for secondary measures. No within-group changes were seen in the primary outcome measure (10-m walk test) in either group. Within-group improvements were seen in several of the secondary measures for both groups. No complications of robotic therapy were observed. CONCLUSIONS: Robotic therapy for ambulatory stroke patients with chronic hemiparesis using a robotic knee brace resulted in only modest functional benefits that were comparable with a group exercise intervention.

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