Stroke: Botulinum toxin improved spastic foot.

Clinical bottom line (level 1b)

  1. Patients with spastic foot who were given botulinum toxin were more likely to have an improvement in ankle function than those given placebo.
  2. Patients who were given botulinum toxin are more likely to have an improvement in clinical gait assessment.
  3. Patients given botulinum toxin were more likely to feel an improvement than those given placebo (NNT = 1 at 4 weeks) .
  4. There was no clear difference in mean Fugl-Meyer scale or mean gait.
Burbaud et al: Journal of Neurology, Neurosurgery and Psychiatry 1996; 61: 265-269
Expires November 2002

The study

Double-blinded ?concealed randomised cross-over trial with intention-to-treat
Setting: several rehabilitation centres, France

23 patients (aged range 14 to 72 years; mean 51, 69.5% male) moderate to severe spasticity of the ankle plantar flexors and foot invertors and a lack of response to conventional physical and medical treatment

Excluded if
  • spasticity <3 months
  • fixed joint posture
  • pregnancy
  • neuromuscular diseases


    • Control Group: (n = 23, 23 analysed): placebo
    Experimental Group: (n = 23, 23 analysed): botulinum toxin A - diluted with saline to a concentration of 200 Dysport units/ ml (total volume 5 ml) and injected through a 26 gauge injectrode under electromyographic guidance in 2 to 6 points per muscle

    100% followed for 1 months
    Outcome notes:
    • no improvement : according to patient

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    no improvement 4 weeks 19
    (82.6%)    		 3
    (13.0%)    		 84%
    (54% to 95%)    		 69.6%
    (48.8% to 90.3%)    		 1
    (1 to 2)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    mean on Fugl-Meyer scale (ankle dorsiflexion in the supine, sitting and standing positions) 23.5
    (4.90)     		25.0
    (4.70)     		1.50
    (-1.35 to 4.35)
    mean gait velocity (cm/s) 25.1
    (17.1)     		29.4
    (16.4)     		4.30
    (-5.66 to 14.3)
    mean Ashworth ankle extensors 3.70
    (0.70)     		2.40
    (0.90)     		-1.30
    (-0.82 to -1.78)
    mean Ashworth ankle invertors 2.80
    (0.90)     		1.80
    (0.90)     		-1.00
    (-0.47 to -1.54)
    mean Active ankle dorsiflexion 2.20
    (1.50)     		3.30
    (1.40)     		1.10
    (0.24 to 1.96)
    mean clinical gait assessment (video score) 3.10
    (0.60)     		2.00
    (0.60)     		-1.10
    (-0.74 to -1.46)

  • Mean differences were calculated with before treatment and after treatment measurements.
  • Video score was assessed blindly and considered the severity of equinovarus deformity, instability of gait stance and the existence of knee extension.

    • Citation

    1. Burbaud P, Wiart L, Dubos JL, et al: A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. Journal of Neurology, Neurosurgery and Psychiatry 1996; 61: 265-269
    Contributor: Clare Wotton and Musab Hayatli, November 1999
    Reviewer:

    Clinical Question.
    Patient spastic foot
    Intervention or Exposure botulinum toxin
    Comparison placebo
    Outcome improvement in spasticity