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

El‐Etribi 2004.

Methods Method of randomisation: not described
Blinding: not described. Participants and personnel were likely not blinded due to the nature of the interventions.
Intention‐to‐treat analysis: no
Loss of follow‐up: no
Unit of analysis: not described clearly, but likely lower limb for local measures and child for global measures
Participants Place: 1 centre in Egypt
Period of study: March 2001 to March 2003
Number assigned: 40
Number assessed: 40
  • 20 BoNT‐A group

  • 20 control group


Inclusion criteria:
  • Children aged 2 to 6 years at study entry

  • Mobile equinus of the ankle


Exclusion criteria:
  • Severe or profound mental retardation

  • Fixed contractures

  • Atrophy of leg muscles

  • Previous alcohol or phenol injection into the muscles


Age:
  • BoNT‐A group (mean/SD): 3.43/1.5 years

  • Control group (mean/SD): 3.68/1.15 years


Gender:
  • Not described


Motor distribution:
  • All spastic diplegia


GMFCS:
  • Not described

Interventions BoNT‐A group:
  • Single BoNT‐A injection (onabotulinumtoxinA) into the gastrocnemius, hip adductors, and/or hamstrings (dose 3 to 6 U/kg), not exceeding 200 U for any single injection

  • Physiotherapy 3x/week for 3 months


Control group:
  • Physiotherapy 3x/week for 3 months

Outcomes Length of follow‐up:
  • Follow‐up of 12 weeks

  • Assessments at baseline, 4, 8, and 12 weeks


Primary outcomes:
  • Modified Ashworth Scale

  • Modification of the Physician Rating Scale

  • Range of motion of the ankle

  • Electromyogram (H/M rating)

Notes Comments:
  1. Data for 4 and 8 weeks were only available in the form of graphs. Numeric data were available only for baseline and 12 weeks.


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 High risk Comment: participants and personnel likely not blinded due to the nature of the interventions
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: not described, but likely not given the nature of the interventions and assessments
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no incomplete 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