Neuropediatrics 1999; 30(3): 120-124
DOI: 10.1055/s-2007-973475
Original articles

© Hippokrates Verlag GmbH Stuttgart

Botulinum Toxin A in the Management of Spastic Gait Disorders in Children and Young Adults with Cerebral Palsy: A Randomized, Double-Blind Study of "High-Dose" versus "Low-Dose" Treatment*

J. Wissel1 , F. Heinen3 , A. Schenkel2 , B. Doll4 , G. Ebersbach1 , J. Müller1 , W. Poewe1
  • 1Departments of Neurology, Universitätsklinik Innsbruck, Austria,
  • 2Departments of Virchow Klinikum, Charité, Berlin, Germany,
  • 3Department of Neuropediatrics, Universitätsklinik, Freiburg, Germany,
  • 4Department of Orthopedics, Oskar-Helene-Heim, Berlin, Germany
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12. März 2007 (online)


The present study was performed to assess dose-response relationships of local botulium toxin A (BtxA) treatment in children and teenagers with spastic gait due to cerebral palsy (CP) in a randomized, double-blind study employing a "high-dose" (200 units Botox® per leg) and a "low-dose" (100 units Botox® per leg) treatment arm in 33 patients with CP.

Response parameters included changes in muscle tone assessed by the Ashworth scale at knee joint, range-of-motion (ROM) measurements at knee and ankle joint, objective analysis of longitudinal gait parameters as well as subjective assessments of improvement.

Patients in the "high-dose" arm received 40-80 units Botox®/muscle versus 20-40 units Botox®/muscle in the "low-dose" group. Patients in both treatment arms showed significant improvement of Ashworth score (p < 0.001) and ROM (p < 0.01), while gait analysis revealed significant increase in gait velocity (p < 0.01) and stride-length (p < 0.001) over baseline. Subjects in the "high-dose" group showed significantly greater improvement on objective response measurements compared to "low-dose" patients. Also, children aged 7 years or less had greater functional benefit compared to the subgroup of patients older than 7 years. Incidence and severity of side-effects were similar in both treatment groups.

The present study demonstrated dose-dependent functional improvement of dynamic deformities and spastic gait pattern in children and young adults with CP treated with local injections of botulium toxin. A dose of 200 units Botox® per leg distributed to 4 or 5 muscle bellies per leg is superior compared to 100 units Botox® per leg without significantly affecting the risk of side-effects.