A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport®) in the treatment of spastic equinovarus deformity after stroke

Cerebrovascular Diseases

Volumn 15, Issue 4, 2003, Pages 289-300

  Pittock, S J ^a,o   Moore, A P ^b   Hardiman, O ^a   Ehler, E ^c   Kovac, M ^c   Bojakowski, J ^d   Al Khawaja, I ^e   Brozman, M ^c   Kanovsky P ^f   Skorometz, A ^g   Slawek, J ^h   Reichel, G ⁱ   Stenner, A ⁱ   Timerbaeva, S ^j   Stelmasiak, Z ^k   Zifko, U A ^l   Bhakta, B ^m   Coxon, E ⁿ  

^a BEAUMONT HOSPITAL   (Ireland)

^b WALTON CENTRE FOR NEUROLOGY AND NEUROSURGERY   (United Kingdom)

^c Department of Neurology ^*  (Slovakia)

^d MEDICAL UNIVERSITY OF WARSAW   (Poland)

^e Hayword Hospital   (United Kingdom)

^f ST ANNE S UNIVERSITY HOSPITAL   (Czech Republic)

^g PAVLOV FIRST SAINT PETERSBURG STATE MEDICAL UNIVERSITY   (Russian Federation)

^h Department of Neurology   (Poland)

ⁱ Paracelsus Klinik Zwickau   (Germany)

^j INSTITUTE OF BIOMEDICAL CHEMISTRY   (Russian Federation)

^k Faculty of Medicine   (Poland)

^l Kur und Rehabilitationszentrum   (Austria)

^m UNIVERSITY OF LEEDS   (United Kingdom)

ⁿ IPSEN   (France)

^o MAYO CLINIC   (United States)

more..

Author keywords

Botulinum toxin; Calf; Dysport; Equinovarus deformity; Pain; Rehabilitation; Spasticity; Stroke; Walking

Indexed keywords

BOTULINUM TOXIN A;

ADULT; AGED; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSAGE FORM; DRUG EFFECT; DRUG EFFICACY; DRUG SCREENING; DYSPHAGIA; EDEMA; FEMALE; GAIT DISORDER; GASTROCNEMIUS MUSCLE; HEADACHE; HUMAN; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MEDICAL ASSESSMENT; MOTOR ACTIVITY; MULTICENTER STUDY; MUSCLE HYPERTONIA; MUSCLE TONE; MYASTHENIA; PAIN; PANCREATITIS; PARESTHESIA; PES EQUINOVARUS; PHARYNGITIS; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; SPASTICITY; STROKE; TREATMENT OUTCOME; VERTIGO; WALKING; WALKING AID;

ADULT; AGED; BOTULINUM TOXIN TYPE A; CEREBROVASCULAR ACCIDENT; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; EQUINUS DEFORMITY; FEMALE; GAIT DISORDERS, NEUROLOGIC; HUMANS; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; MUSCLE SPASTICITY; MUSCLE, SKELETAL; NEUROMUSCULAR AGENTS; PROSPECTIVE STUDIES; TIME FACTORS; WALKING;

EID: 0037261997     PISSN: 10159770     EISSN: None     Source Type: Journal    
DOI: 10.1159/000069495     Document Type: Article

References (36)

1. Nadeau S, Gravel D, Arsenault AB, Bourbonnais D: Plantarflexor weakness as a limiting factor of gait speed in stroke subjects and the compensating role of hip flexors. Clin Biomech (Bristol, Avon) 1999;14:125-135.
2. Young RR, Delwaide PJ: Drug therapy: Spasticity. Part 1. New Engl J Med 1981;304:28-33.
3. Young RR, Delwaide PJ: Drug therapy: Spasticity. Part 2. New Engl J Med 1981;304:96-99.
4. Katz RT: Management of spasticity. Am J Phys Med Rehabil 1988;67:108-116.
5. Penn RD, Savoy SM, Corcos D, Latash ML, Gottlieb G: Intrathecal baclofen for severe spinal spasticity. New Engl J Med 1989;320: 1517-1521.
6. Herz DA, Looman JE, Tiberio A, Ketterling K, Kreitsch RK, Colwill JC, Grin OD: The management of paralytic spasticity. Neurosurgery 1990;26:300-306.
7. Sutherland DH, Kaufman KR, Wyatt MP, Chambers HG: Injection of botulinum A toxin into the gastrocnemius muscle of patients with cerebral palsy: A 3-dimensional motion analysis study. Gait Posture 1996;4:269-279.
8. Corry IS, Cosgrove AP, Walsh EG, McClean D, Graham HK: Botulinum toxin A in the hemiplegic upper limb: A double-blind trial. Dev Med Child Neurol 1997;39:185-193.
9. Bhakta BB, Cozens JA, Bamford JM, Chamberlain MA: Use of botulinum toxin in stroke patients with severe upper limb spasticity. J Neurol Neurosurg Psychiatry 1996;61:30-35.
10. Bhakta BB, Cozens JA, Chamberlain MA, Bamford JM: Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: A randomised double-blind placebo-controlled trial. J Neurol Neurosurg Psychiatry 2000;69:217-221.
11. Bakheit AM, Thilmann AF, Ward AB, Poewe W, Wissel J, Muller J, Benecke R, Collin C, Muller F, Ward CD, Neumann C: A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke 2000;31:2402-2406.
12. Burbaud P, Wiart L, Dubos JL, Gaujard E, Debelleix X, Joseph P, Mazaux JM, Bioulac B, Barat M, Lagueny A: A randomised, double-blind, placebo-controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry 1996;61:265-269.
13. Hesse S, Krajnik J, Luecke D, Jahnke MT, Gregoric M, Mauritz KH: Ankle muscle activity before and after botulinum toxin therapy for lower limb extensor spasticity in chronic hemiparetic patients. Stroke 1996;27:455-460.
14. Simpson DM, Alexander DN, O'Brien CF, Tagliati M, Aswad AS, Leon JM, Gibson J, Mordaunt JM, Monaghan EP: Botulinum toxin type A in the treatment of upper extremity spasticity: A randomised, double-blind, placebo-controlled trial. Neurology 1996;46:1306-1310.
15. Sheean GL: Botulinum treatment of spasticity: Why is it so difficult to show a functional benefit? Curr Opin Neurol 2001;14:771-776.
16. Hatano S: Experience from a multicentre stroke register: A preliminary report. Bull World Health Organ 1976;54:541-553.
17. Butland RJA, Pang J, Gross ER, Woodcock AA, Geddes DM: Two-, six- and 12-minute walking tests in respiratory disease. BMJ 1982;284:1607-1608.
18. Lincoln N, Leadbitter D: Assessment of motor function in stroke patients. Physiotherapy 1979;65:48-51.
19. Bohannon RW, Smith MB: Inter-rater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987;67:206-207.
20. US Food and Drug Administration: COSTART: Coding Symbols for Thesaurus of Adverse Reaction terms, ed 5. Rockville, 1995.
21. Mauritz K-H, Hesse S: Neurological rehabilitation of gait and balance disorders; in Bronstein A, et al. (eds): Clinical Disorders of Balance, Posture and Gait. London, Arnold, 1996, pp 236-250.
22. Dodd SL, Rowell BA, Vrabas IS, Arrowsmith RJ, Weatherill PJ: A comparison of the spread of three formulations of botulinum neurotoxin A as determined by effects on muscle function. Eur J Neurol 1998;5:181-186.
23. Borodic GE, Joseph M, Fay L, Cozzolino D, Ferrante RJ: Botulinum A toxin for the treatment of spasmodic torticollis: Dysphagia and regional toxin spread. Head Neck 1990;12:392-399.
24. Eleopra R, Tugnoli V, Caniatti L, De Grandis D: Botulinum toxin treatment in the facial muscles of humans: Evidence of an action in untreated near muscles by peripheral local diffusion. Neurology 1996;46:1158-1160.
25. Geenen C, Consky E, Ashby P: Localizing muscles for botulinum toxin treatment of focal hand dystonia. Can J Neurol Sci 1996;23:194-197.
26. Ross MH, Charness ME, Sudarsky L, Logigian EL: Treatment of occupational cramp with botulinum toxin: Diffusion of toxin to adjacent non-injected muscles. Muscle Nerve 1997;20:593-598.
27. Snow BJ, Tsui JKC, Bhatt MH, Varelas M, Hashimoto SA, Calne BD: Treatment of spasticity with botulinum toxin: A double-blind study. Ann Neurol 1990;28:512-515.
28. Molteni F: Botulinum toxin and rehabilitation programs in lower limb spasticity. Eur J Neurol 1995;2:61-67.
29. Pandyan AD, Johnson GR, Price CI, Curless RH, Barnes MP, Rodgers H: A review of the properties and limitations of the Ashworth and modified Ashworth Scales as measures of spasticity. Clin Rehabil 1999;13:373-383.
30. Das TK, Park DM: Effect of treatment with botulinum toxin on spasticity. Postgrad Med J 1989;65:208-210.
31. Dengler R, Neyer U, Wohlfarth K, Bettig U, Janzik HH: Local botulinum toxin in the treatment of spastic foot drop. J Neurol 1992;239:375-378.
32. Hesse S, Lücke D, Malezic M, Bertelt C, Friedrich H, Gregoric M, Mauritz K-H: Botulinum toxin treatment for lower limb extensor spasticity in chronic hemiparetic patients. J Neurol Neurosurg Psychiatry 1994;57:1321-1324.
33. Dunne JW, Heye N, Dunne SL: Treatment of chronic limb spasticity with botulinum toxin A. J Neurol Neurosurg Psychiatry 1995;58:232-235.
34. Reiter F, Danni M, Ceravolo MG, Provinciali L: Disability changes after treatment of upper limb spasticity with botulinum toxin. J Neurol Rehabil 1996;10:47-52.
35. Wissel J, Muller J, Dressnandt J, Heinen F, Naumann M, Topka H, Poewe W: Management of spasticity-associated pain with botuli-num toxin. J Pain Symptom Manage 2000;20:44-49.
36. Rice-Oxley M, Turner-Stokes L: Effectiveness of brain injury rehabilitation. Clin Rehabil 1999;13:7-24.