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. 2000 Dec;83(6):481–487. doi: 10.1136/adc.83.6.481

Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy

T Ubhi 1, B Bhakta 1, H Ives 1, V Allgar 1, S Roussounis 1
PMCID: PMC1718586  PMID: 11087280

Abstract

BACKGROUND—Cerebral palsy is the commonest cause of severe physical disability in childhood. For many years treatment has centred on the use of physiotherapy and orthotics to overcome the problems of leg spasticity, which interferes with walking and can lead to limb deformity. Intramuscular botulinum toxin (BT-A) offers a targeted form of therapy to reduce spasticity in specific muscle groups.
AIMS—To determine whether intramuscular BT-A can improve walking in children with cerebral palsy.
DESIGN—Randomised, double blind, placebo controlled trial.
METHODS—Forty patients with spastic diplegia or hemiplegia were enrolled. Twenty two received botulinum toxin and 18 received placebo. The primary outcome measure was video gait analysis and secondary outcome measures were gross motor function measure (GMFM), physiological cost index (PCI), and passive ankle dorsiflexion.
RESULTS—Video gait analysis showed clinically and statistically significant improvement in initial foot contact following BT-A at six weeks and 12 weeks compared to placebo. Forty eight per cent of BT-A treated children showed clinical improvement in VGA compared to 17% of placebo treated children. The GMFM (walking dimension) showed a statistically significant improvement in favour of the botulinum toxin treated group. Changes in PCI and passive ankle dorsiflexion were not statistically significant.
CONCLUSION—The study gives further support to the use of intramuscular botulinum toxin type A as an adjunct to conventional physiotherapy and orthoses to reduce spasticity and improve functional mobility in children with spastic diplegic or hemiplegic cerebral palsy.



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Selected References

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  1. Blasi J., Chapman E. R., Link E., Binz T., Yamasaki S., De Camilli P., Südhof T. C., Niemann H., Jahn R. Botulinum neurotoxin A selectively cleaves the synaptic protein SNAP-25. Nature. 1993 Sep 9;365(6442):160–163. doi: 10.1038/365160a0. [DOI] [PubMed] [Google Scholar]
  2. Botte M. J., Abrams R. A., Bodine-Fowler S. C. Treatment of acquired muscle spasticity using phenol peripheral nerve blocks. Orthopedics. 1995 Feb;18(2):151–159. doi: 10.3928/0147-7447-19950201-14. [DOI] [PubMed] [Google Scholar]
  3. Butler P., Engelbrecht M., Major R. E., Tait J. H., Stallard J., Patrick J. H. Physiological cost index of walking for normal children and its use as an indicator of physical handicap. Dev Med Child Neurol. 1984 Oct;26(5):607–612. doi: 10.1111/j.1469-8749.1984.tb04499.x. [DOI] [PubMed] [Google Scholar]
  4. Campbell S. K. Quantifying the effects of interventions for movement disorders resulting from cerebral palsy. J Child Neurol. 1996 Nov;11 (Suppl 1):S61–S70. doi: 10.1177/0883073896011001S09. [DOI] [PubMed] [Google Scholar]
  5. Carr L. J., Cosgrove A. P., Gringras P., Neville B. G. Position paper on the use of botulinum toxin in cerebral palsy. UK Botulinum Toxin and Cerebral Palsy Working Party. Arch Dis Child. 1998 Sep;79(3):271–273. doi: 10.1136/adc.79.3.271. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. Corry I. S., Cosgrove A. P., Duffy C. M., McNeill S., Taylor T. C., Graham H. K. Botulinum toxin A compared with stretching casts in the treatment of spastic equinus: a randomised prospective trial. J Pediatr Orthop. 1998 May-Jun;18(3):304–311. [PubMed] [Google Scholar]
  7. Cosgrove A. P., Corry I. S., Graham H. K. Botulinum toxin in the management of the lower limb in cerebral palsy. Dev Med Child Neurol. 1994 May;36(5):386–396. doi: 10.1111/j.1469-8749.1994.tb11864.x. [DOI] [PubMed] [Google Scholar]
  8. Cosgrove A. P., Graham H. K. Botulinum toxin A prevents the development of contractures in the hereditary spastic mouse. Dev Med Child Neurol. 1994 May;36(5):379–385. doi: 10.1111/j.1469-8749.1994.tb11863.x. [DOI] [PubMed] [Google Scholar]
  9. Diamond M. Rehabilitation strategies for the child with cerebral palsy. Pediatr Ann. 1986 Mar;15(3):230-4, 236. doi: 10.3928/0090-4481-19860301-08. [DOI] [PubMed] [Google Scholar]
  10. Djulbegovic B., Lacevic M., Cantor A., Fields K. K., Bennett C. L., Adams J. R., Kuderer N. M., Lyman G. H. The uncertainty principle and industry-sponsored research. Lancet. 2000 Aug 19;356(9230):635–638. doi: 10.1016/S0140-6736(00)02605-2. [DOI] [PubMed] [Google Scholar]
  11. Eames N. W., Baker R., Hill N., Graham K., Taylor T., Cosgrove A. The effect of botulinum toxin A on gastrocnemius length: magnitude and duration of response. Dev Med Child Neurol. 1999 Apr;41(4):226–232. doi: 10.1017/s0012162299000493. [DOI] [PubMed] [Google Scholar]
  12. Erbguth F., Claus D., Engelhardt A., Dressler D. Systemic effect of local botulinum toxin injections unmasks subclinical Lambert-Eaton myasthenic syndrome. J Neurol Neurosurg Psychiatry. 1993 Nov;56(11):1235–1236. doi: 10.1136/jnnp.56.11.1235. [DOI] [PMC free article] [PubMed] [Google Scholar]
  13. Forssberg H., Tedroff K. B. Botulinum toxin treatment in cerebral palsy: intervention with poor evaluation? Dev Med Child Neurol. 1997 Sep;39(9):635–640. doi: 10.1111/j.1469-8749.1997.tb07501.x. [DOI] [PubMed] [Google Scholar]
  14. Haddad D., Robertson K. J., Cockburn F., Helms P., McIntosh N., Olver R. E. What is core? Guidelines for the core curriculum in paediatrics. Med Educ. 1997 Sep;31(5):354–358. doi: 10.1046/j.1365-2923.1997.00675.x. [DOI] [PubMed] [Google Scholar]
  15. Hainsworth F., Harrison M. J., Sheldon T. A., Roussounis S. H. A preliminary evaluation of ankle orthoses in the management of children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):243–247. doi: 10.1111/j.1469-8749.1997.tb07419.x. [DOI] [PubMed] [Google Scholar]
  16. Jankovic J., Brin M. F. Therapeutic uses of botulinum toxin. N Engl J Med. 1991 Apr 25;324(17):1186–1194. doi: 10.1056/NEJM199104253241707. [DOI] [PubMed] [Google Scholar]
  17. Koman L. A., Mooney J. F., 3rd, Smith B. P., Goodman A., Mulvaney T. Management of spasticity in cerebral palsy with botulinum-A toxin: report of a preliminary, randomized, double-blind trial. J Pediatr Orthop. 1994 May-Jun;14(3):299–303. doi: 10.1097/01241398-199405000-00005. [DOI] [PubMed] [Google Scholar]
  18. Koman L. A., Mooney J. F., 3rd, Smith B. P., Walker F., Leon J. M. Botulinum toxin type A neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trial. BOTOX Study Group. J Pediatr Orthop. 2000 Jan-Feb;20(1):108–115. [PubMed] [Google Scholar]
  19. Koman L. A., Mooney J. F., 3rd, Smith B., Goodman A., Mulvaney T. Management of cerebral palsy with botulinum-A toxin: preliminary investigation. J Pediatr Orthop. 1993 Jul-Aug;13(4):489–495. doi: 10.1097/01241398-199307000-00013. [DOI] [PubMed] [Google Scholar]
  20. Kralewski J., Stevens-Simon C. Does mothering a doll change teens' thoughts about pregnancy? Pediatrics. 2000 Mar;105(3):E30–E30. doi: 10.1542/peds.105.3.e30. [DOI] [PubMed] [Google Scholar]
  21. Massin M., Allington N. Role of exercise testing in the functional assessment of cerebral palsy children after botulinum A toxin injection. J Pediatr Orthop. 1999 May-Jun;19(3):362–365. [PubMed] [Google Scholar]
  22. Neville B. Botulinum toxin in the cerebral palsies. BMJ. 1994 Dec 10;309(6968):1526–1527. doi: 10.1136/bmj.309.6968.1526. [DOI] [PMC free article] [PubMed] [Google Scholar]
  23. Rose J., Gamble J. G., Lee J., Lee R., Haskell W. L. The energy expenditure index: a method to quantitate and compare walking energy expenditure for children and adolescents. J Pediatr Orthop. 1991 Sep-Oct;11(5):571–578. [PubMed] [Google Scholar]
  24. Russell D. J., Rosenbaum P. L., Cadman D. T., Gowland C., Hardy S., Jarvis S. The gross motor function measure: a means to evaluate the effects of physical therapy. Dev Med Child Neurol. 1989 Jun;31(3):341–352. doi: 10.1111/j.1469-8749.1989.tb04003.x. [DOI] [PubMed] [Google Scholar]
  25. Steinbok P., Reiner A., Kestle J. R. Therapeutic electrical stimulation following selective posterior rhizotomy in children with spastic diplegic cerebral palsy: a randomized clinical trial. Dev Med Child Neurol. 1997 Aug;39(8):515–520. doi: 10.1111/j.1469-8749.1997.tb07479.x. [DOI] [PubMed] [Google Scholar]
  26. Stuberg W. A., Fuchs R. H., Miedaner J. A. Reliability of goniometric measurements of children with cerebral palsy. Dev Med Child Neurol. 1988 Oct;30(5):657–666. doi: 10.1111/j.1469-8749.1988.tb04805.x. [DOI] [PubMed] [Google Scholar]
  27. Sutherland D. H., Kaufman K. R., Wyatt M. P., Chambers H. G., Mubarak S. J. Double-blind study of botulinum A toxin injections into the gastrocnemius muscle in patients with cerebral palsy. Gait Posture. 1999 Sep;10(1):1–9. doi: 10.1016/s0966-6362(99)00012-0. [DOI] [PubMed] [Google Scholar]
  28. Tsui J. K., Eisen A., Stoessl A. J., Calne S., Calne D. B. Double-blind study of botulinum toxin in spasmodic torticollis. Lancet. 1986 Aug 2;2(8501):245–247. doi: 10.1016/s0140-6736(86)92070-2. [DOI] [PubMed] [Google Scholar]
  29. Wissel J., Heinen F., Schenkel A., Doll B., Ebersbach G., Müller J., Poewe W. 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. Neuropediatrics. 1999 Jun;30(3):120–124. doi: 10.1055/s-2007-973475. [DOI] [PubMed] [Google Scholar]
  30. Wong V. Use of botulinum toxin injection in 17 children with spastic cerebral palsy. Pediatr Neurol. 1998 Feb;18(2):124–131. doi: 10.1016/s0887-8994(97)00164-1. [DOI] [PubMed] [Google Scholar]
  31. Wright F. V., Sheil E. M., Drake J. M., Wedge J. H., Naumann S. Evaluation of selective dorsal rhizotomy for the reduction of spasticity in cerebral palsy: a randomized controlled tria. Dev Med Child Neurol. 1998 Apr;40(4):239–247. doi: 10.1111/j.1469-8749.1998.tb15456.x. [DOI] [PubMed] [Google Scholar]

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