Robot-assisted therapy (RT) and intensive comparison treatment (ICT), structured to match that of RT with regard to number of sessions, type, and intensity of movement, were superior to customary chronic poststroke care (usual care – UC) for the treatment of chronic stroke that affected the upper extremities. Extremity function greatly affects the overall outcome of chronic stroke; therefore, improvement of extremity function is a critical aim of rehabilitation [Olsen TS et al. Stroke 1990]. Albert Lo, MD, PhD, Providence VA Medical Center, Providence, RI, discussed the use of novel RT as a rehabilitation strategy to improve functionality and quality of life in patients ≥6 months poststroke.

In this study by Lo and colleagues, patients with an index stroke that occurred at least 6 months prior to enrollment (mean time since stroke 4.7 years), resulting in moderate to severe upper extremity impairment as measured by Fugl-Meyer score of 7 to 38 (out of a possible 66 points), were randomized to receive RT (n=49), ICT (n=50), or UC (n=28) for 36 sessions over a 12-week period. Patients who experienced multiple strokes (33%) were also included in this study, provided the index stroke was ≥6 months prior to enrollment. There was no significant difference in baseline characteristics across the groups. RT entailed using a 4-module robotic system, which included a vertical, horizontal, hand, and wrist unit, and produced >1000 intensive movements per session. ICT was equivalent to the RT model (also producing >1000 intensive movements/session), and UC utilized conventional methods, such as a 5-foot pole with a sliding base, a hand odometer, and a horizontal “hand skate.”

Evaluations were performed at Weeks 6, 12, 24, and 36. The primary endpoints were motor capacity, as assessed by Fugl-Meyer score, and safety, as determined by spasticity (using modified Ashworth) and pain (using a numerical scale) immediately following the completion of therapy at 12 weeks. Secondary endpoints were the difference in Wolf Motor Function Test and Stroke Impact Scale (composite of hand, mobility, activities of daily life tasks, and participation) over 36 weeks (including treatment and 6 months of follow-up).

There was no significant difference in Fugl-Meyer score between RT and ICT or UC at 12 weeks. However, at 36 weeks, 12 weeks posttreatment, a mean point difference of +2.88 in Fugl-Meyer score was observed in RT patients versus UC (p=0.016). Additionally, the mean change in Wolf Motor Function for RT versus UC was statistically significant at 36 weeks (p=0.005), though no other significant changes in Wolf Motor Function were noted at either 12 or 36 weeks. RT demonstrated significant improvement in Stroke Impact Scale at 12 weeks (p=0.009) and 36 weeks (p=0.04) compared with UC. There was no difference between RT and ICT for any outcome.

There were no treatment-related serious adverse events (AEs) that were observed. However, there were some treatment-related AEs that were associated with RT (12%) and ICT (9%) that were considered transient and mild (Table 1). None of these events occurred in the UC group.

Outcomes were better for RT and ICT than UC over the 36-week evaluation period despite the high severity, chronicity, and incidence of multiple strokes in this patient population. Additionally, RT and ICT curtailed the use of additional health services over time, resulting in overall costs that were similar to those that were associated with UC. This study has shown that high-intensity repetition of movement can improve quality of life and extremity functionality in individuals with stroke-related impairment, concluded Dr. Lo. RT is a safe and effective rehabilitation strategy that merits further investigation.