Skip to main content
. 2019 Oct 8;2019(10):CD001408. doi: 10.1002/14651858.CD001408.pub2

Koman 1994.

Methods Method of randomisation: not described
Blinding: double‐blind study
Intention‐to‐treat analysis: no
Loss of follow‐up: no losses to follow‐up
Unit of analysis: lower limb for local measures and child for global measures
Participants Place: 1 centre in the USA
Period of study: not described
Number assigned: 12
Number assessed: 12
  • 6 BoNT‐A group

  • 6 placebo group


Inclusion criteria:
  • Non‐progressive lesion resulting in spasticity (CP)

  • Equinovarus or equinovalgus dynamic foot deformities unresponsive to conventional treatment


Exclusion criteria:
  • Significant health issues


Age:
  • Both groups (range): 4 to 11 years


Gender:
  • Not described


Motor distribution:
  • Both groups: 4 hemiplegia; 8 diplegia


GMFCS:
  • Not described, but since all children were walkers, likely GMFCS I, II, and III

Interventions BoNT‐A group:
  • Initial BoNT‐A injection into the gastrocnemius muscles (onabotulinumtoxinA) 1 U/kg per side. In equinovarus deformities, the tibialis posterior was also injected.

  • Second BoNT‐A injection (onabotulinumtoxinA) 2 U/kg per side at the same injection sites


Placebo group:
  • Placebo (saline) injections in a similar fashion as in the BoNT‐A group

Outcomes Length of follow‐up:
  • The final evaluation was made after a 4‐ to 6‐week interval from the first injection


Primary outcomes:
  • Physician Rating Scale

  • Biodex isokinetic computerised dynamometry

  • Physiotherapy evaluations

  • Parent/guardian assessment

Notes Comments:
  1. Since both injections were given only 2 weeks apart, and at a low dose each, we considered this as a single‐injection study for the purposes of our review


Source of funding: not reported
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: not described
Allocation concealment (selection bias) Unclear risk Comment: not described
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: double‐blind study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: outcome assessors were blind to group allocation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Comment: study protocol not available. It appears that the relevant outcomes were addressed.
Other bias Low risk Comment: no other sources of bias identified