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EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE
Rivista di Medicina Fisica e Riabilitativa dopo Eventi Patologici
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Indexed/Abstracted in: CINAHL, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
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European Journal of Physical and Rehabilitation Medicine 2013 August;49(4):483-9
Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post-stroke lower limb spasticity: a prospective open-label study
Santamato A. 1, Micello M. F. 1, Panza F. 2, Fortunato F. 3, Pilotto A. 2, 4, Giustini A. 5, Testa A. 5, Fiore P. 1, Ranieri M. 6, Spidalieri R. 5 ✉
1 Department of Physical Medicine and Rehabilitation OORR Hospital, University of Foggia, Foggia, Italy;
2 Geriatric Unit amd Gerontology, Geriatrics Research Laboratory, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy;
3 Section of Hygiene, Department of Medical and Occupational Science, University of Foggia, Foggia, Italy;
4 Geriatric Unit, Health Local Unit 16 Padoa, S. Antonio Hospital, Padoa, Italy;
5 Arìa, Agazzi Institute of Neurological Rehabilitation, Arezzo, Italy;
6 Department of Neurological and Psychiatric Sciences University of Bari, Bari, Italy
Background: In recent years, NT 201, a new botulinum toxin type A (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 BTX-A NT 201 free from complexing proteins for the treatment of post-stroke lower limb 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 physicians.
Design: Prospective open-label study.
Population: Patients (71) with post-stroke lower limb spasticity at least 5 months by the event.
Methods: Intramuscular injections of BTX-A NT 201 in soleus, medial, and lateral gastrocnemius with a maximum total dose of 180 U. Each patients was assessed at baseline, 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 BTX-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.
Conclusion: BTX-A NT 201 for the treatment of post-stroke lower limb spasticity was safe and efficacious reducing muscle tone and spasms, and improving passive ankle dorsi-flexion movement.
Clinical rehabilitation impact: These results confirmed the safety and effectiveness of a new type of BTX-A, with low immunogenity, useful to improve rehabilitative treatment of post-stroke lower limb spasticity