Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke

So now we need followup to find out EXACTLY what upper limb interventions are effective. This just launches us to next steps which stroke leadership should be doing.  BUT WE HAVE NO LEADERSHIP, so nothing will occur.

Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke

The InTENSE Trial

Natasha A. Lannin, PhD,^1,10 Louise Ada, PhD,³ Coralie English, PhD,⁵ Julie Ratcliffe, PhD,⁶ Steven G. Faux, MBBS,^8,9 Mithu Palit, MBBS,¹⁰ Senen Gonzalez, MBBS,¹¹ John Olver, MBBS,² Ian Cameron, PhD,⁴ and Maria Crotty, PhD⁷, on behalf of the InTENSE Trial Group^*

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This article has been corrected. See Stroke. 2020 February; 51(2): e45.

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Background and Purpose—

The aim of this trial was to determine the effect of additional upper limb rehabilitation following botulinum toxin-A for upper limb activity in chronic stroke.

Methods—

We conducted a multicenter phase III randomized trial with concealed allocation, blinded measurement, and intention-to-treat analysis. One hundred forty stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke >3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life.

Results—

In terms of goal attainment, the experimental group scored the same (mean difference, 2 T-score [95% CI, −2 to 7]) as the control group on the Goal Attainment Scale. In terms of upper limb activity, by 3 months the experimental group moved blocks at the same speed (mean difference, 0.00 blocks/s [95% CI, −0.02 to 0.01]) as the control group on the Box and Block Test. There were no differences between groups on any secondary outcome except strength, in favor of the experimental group (mean difference, 1.4 kg [95% CI, 0.2–2.7]).

Conclusions—

Findings suggest that additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not effective.

Registration—

URL: https://www.clinicaltrials.gov. Unique identifier: ACTRN12615000616572.