Volume 10, Issue 7, Pages (July 2018)

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Volume 10, Issue 7, Pages 693-703 (July 2018) OnabotulinumtoxinA for the Treatment of Poststroke Distal Lower Limb Spasticity: A Randomized Trial Theodore Wein, MD, Alberto Esquenazi, MD, Wolfgang H. Jost, MD, Anthony B. Ward, MD, Grace Pan, MS, Rozalina Dimitrova, MD PM&R Volume 10, Issue 7, Pages 693-703 (July 2018) DOI: 10.1016/j.pmrj.2017.12.006 Copyright © 2018 American Academy of Physical Medicine and Rehabilitation Terms and Conditions

Figure 1 Study design. MAS, Modified Ashworth Scale; CGI, Clinical Global Impression; GAS, Goal Attainment Scale. PM&R 2018 10, 693-703DOI: (10.1016/j.pmrj.2017.12.006) Copyright © 2018 American Academy of Physical Medicine and Rehabilitation Terms and Conditions

Figure 2 Patient disposition and exit status (intent-to-treat). OL, open-label; TX, treatment cycle. Four patients discontinued before receiving any dose. PM&R 2018 10, 693-703DOI: (10.1016/j.pmrj.2017.12.006) Copyright © 2018 American Academy of Physical Medicine and Rehabilitation Terms and Conditions

Figure 3 Efficacy outcomes. (A) Mean change from baseline for ankle MAS (ITT). (B) Percentage of patients who achieved ≥1 grade reduction in MAS at all time points (ITT). (C) Mean CGI by physician. (D) Proportion of responders for passive and active goals assessed by the physician. MAS, Modified Ashworth Scale; ITT, intent to treat; OL, open-label; TX, treatment cycle; CGI, Clinical Global Impression (as assessed by physician); GAS, Goal Attainment Scale. (A) *P ≤ .03 versus placebo. (B) *P ≤ .04 versus placebo. (C) *P ≤ .04 versus placebo. CGI scores range from –4 = very marked worsening to +4 = very marked improvement. (D) Goal achievement = GAS ≥0; Goal improvement = GAS ≥–1. GAS scores ranged from −3 to +2 (−3 = worse than start; −2 = equal to start, the patient’s initial condition, no change; −1 = less than expected, slight improvement but below the defined therapeutic goal; 0 = expected goal, attained the defined therapeutic goal; +1 = somewhat more than expected, improvement slightly exceeds the defined therapeutic goal; +2 = much more than expected, improvements clearly exceeded the defined therapeutic goal). PM&R 2018 10, 693-703DOI: (10.1016/j.pmrj.2017.12.006) Copyright © 2018 American Academy of Physical Medicine and Rehabilitation Terms and Conditions

Figure 4 Distribution of change in MAS scores from baseline at week 4. (A) OnabotulinumtoxinA. (B) Placebo. MAS, Modified Ashworth Scale. PM&R 2018 10, 693-703DOI: (10.1016/j.pmrj.2017.12.006) Copyright © 2018 American Academy of Physical Medicine and Rehabilitation Terms and Conditions