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Can incobotulinumtoxin-A treatment improve quality of life better than conventional therapy in spastic muscle post-stroke patients? Results from a pilot study from a single center
Turcu-Stiolica A, Subtirelu MS, Bumbea AM
Brain Sciences 2021 Jul;11(7):934
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Post-stroke spasticity frequently occurs in patients with stroke, and there is a need for more quality-of-life assessments for different therapies. We evaluated for the first time in Romania the quality of life among patients with post-stroke spasticity, comparing two therapies over a 6-month period: botulinum toxin type A (BOT) with conventional therapy (CON). We also assessed the reduction of spasticity and functionality secondary to the increase in the mobility in upper limbs. This study was based on a prospective, randomized design, including subjects with post-stroke spasticity (N = 34; 34 to 80 years of age): in the CON arm, patients received therapy against muscle spasticity and physiotherapy, and, in the BOT arm, patients received incobotulinumtoxin-A and additionally conventional treatment, if required. Among 34 treated subjects in the two arms, the quality of life was significantly higher after BOT therapy (p < 0.001), represented by improvement in movement (p < 0.001), usual activities (p = 0.018), and distress (p < 0.001). Improvements in muscle tone (Ashworth Scale) over 6 months of treatment period were greater in the BOT arm (100%) than in the CON arm (11.8%). These preliminary results suggested that incobotulinumtoxin-A increased quality of life by improving movement, daily activities, mental health, and muscle tone more effectively than conventional therapy and could form a basis for future comparator studies.

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