Background: In recent years, NT 201, a new BTX-A free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity. Aim: To assess the safety and evaluate the effects of Botulinum Toxin Type A NT 201 free from complexing proteins for the treatment of post stroke foot spasticity evaluating spasticity grade, passive ankle dorsi-flexion motion, and muscle’s spasms, as well as its efficacy and rate of satisfaction for patients and for the physician. Design: prospective open-label study. Populations: Patients (71) with lower-limb post stroke spasticity at least 5 months by event. Methods: Intramuscular injections of Botulinum Toxin Type A NT 201 in soleus, medial and lateral gastrocnemius with maximum total dose of 180 U. Each patients was assessed before, 30 and 90 days after treatment using Modified Ashworth Scale, Spasm Frequency Scale, evaluating passive ankle dorsi-flexion motion, and the rate of satisfaction for patients and investigators. Results: Patients treated with Botulinum Toxin Type A NT 201 reported a statistically significant reduction in muscle tone and spasms daily increasing passive ankle dorsi-flexion at 30 days persisting also at 90 days of follow up. Conclusions: Botulinum Toxin Type A NT 201 for the treatment of post stroke foot spasticity was safety and efficacious reducing muscle tone, spasms, improving passive ankle dorsi-flexion movement. Clinical rehabilitation impact: these results confirm the safety and effectiveness of a new type of botulinum toxin type A, with low immunogenity, useful to improve rehabilitative treatment of post stroke foot spasticity
Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post stroke foot spasticity: a prospective open label study
FIORE, Pietro;RANIERI, Maurizio;
2013-01-01
Abstract
Background: In recent years, NT 201, a new BTX-A free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity. Aim: To assess the safety and evaluate the effects of Botulinum Toxin Type A NT 201 free from complexing proteins for the treatment of post stroke foot spasticity evaluating spasticity grade, passive ankle dorsi-flexion motion, and muscle’s spasms, as well as its efficacy and rate of satisfaction for patients and for the physician. Design: prospective open-label study. Populations: Patients (71) with lower-limb post stroke spasticity at least 5 months by event. Methods: Intramuscular injections of Botulinum Toxin Type A NT 201 in soleus, medial and lateral gastrocnemius with maximum total dose of 180 U. Each patients was assessed before, 30 and 90 days after treatment using Modified Ashworth Scale, Spasm Frequency Scale, evaluating passive ankle dorsi-flexion motion, and the rate of satisfaction for patients and investigators. Results: Patients treated with Botulinum Toxin Type A NT 201 reported a statistically significant reduction in muscle tone and spasms daily increasing passive ankle dorsi-flexion at 30 days persisting also at 90 days of follow up. Conclusions: Botulinum Toxin Type A NT 201 for the treatment of post stroke foot spasticity was safety and efficacious reducing muscle tone, spasms, improving passive ankle dorsi-flexion movement. Clinical rehabilitation impact: these results confirm the safety and effectiveness of a new type of botulinum toxin type A, with low immunogenity, useful to improve rehabilitative treatment of post stroke foot spasticityI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
