Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial.

Abstract

BACKGROUND:

It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies.

AIM:

To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke.

METHOD:

An analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 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 greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scale) and upper limb activity (Box and Block Test) at 12 months (ie, 9 months beyond the intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life.

RESULTS:

By 12 months, the experimental group scored the same as the control group on the Goal Attainment Scale (MD 0 T-score, 95% CI -5 to 5) and on the Box and Block Test (MD 0.01 blocks/s, 95% CI -0.01 to 0.03). There were no differences between groups on any secondary outcome.

CONCLUSION:

Additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not more effective in the long-term.

TRIAL REGISTRATION:

ACTRN12615000616572 (12/06/2015).

• Authors: Natasha A Lannin, Louise Ada, Coralie English, Julie Ratcliffe, Steven Faux, Mithu Palit, Senen Gonzalez, John Olver, Emma Schneider, Maria Crotty, Ian D Cameron
• Journal: BMC neurology (BMC Neurol) Vol. 22 Issue 1 Pg. 154 (Apr 25 2022) ISSN: 1471-2377 [Electronic] England
• PMID: 35468766 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2022. The Author(s).

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A

Topics

• Botulinum Toxins, Type A (therapeutic use)
• Brain Damage, Chronic
• Humans
• Muscle Spasticity (drug therapy, etiology)
• Neuromuscular Agents (therapeutic use)
• Quality of Life
• Stroke (complications, drug therapy)
• Stroke Rehabilitation
• Treatment Outcome
• Upper Extremity