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. 2019 Oct 8;2019(10):CD001408. doi: 10.1002/14651858.CD001408.pub2

Corry 1998.

Methods Method of randomisation: 1 of 20 cards containing the instruction BoNT‐A or cast was drawn for each participant. Randomisation was restricted to ensure 10 participants in each group.
Blinding: no blinding of participants and personnel providing treatment. The surgeon assessing the postintervention gait videotapes was blinded to the treatment received.
Intention‐to‐treat analysis: no
Loss of follow‐up: no
Unit of analysis: lower limb
Participants Place: 1 centre in Ireland
Period of study: not described
Number assigned: 20
Number assessed: 20
  • 10 BoNT‐A group

  • 10 control group


Inclusion criteria:
  • Children with CP

  • Dynamic component to calf equinus


Exclusion criteria:
  • Children were excluded if their body weight was under 10 kg or there was a medical contraindication to BoNT‐A

  • Study entry was delayed to ensure that no BoNT‐A injections or orthopaedic surgery had occurred within 6 months or change to oral or other antiplasticity treatment (e.g. intrathecal baclofen) within 2 months of study commencement


Age:
  • Both groups (mean/range): 4.6/2 to 9 years


Gender:
  • Males: 13 participants

  • Females: 7 participants


Motor distribution:
  • Both groups: 8 hemiplegia; 11 diplegia; 1 quadriplegia


GMFCS:
  • Not described

Interventions BoNT‐A group:
  • Single BoNT‐A injection into the calf muscles of onabotulinumtoxinA in 8 children (6 to 8 U/kg) and abobotulinumtoxinA in 2 children (15 U/kg)


Control group:
  • Serial casting

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

  • Assessments at baseline, 2 and 12 weeks


Primary outcomes:
  • Clinical examination (ankle range of motion and spasticity)

  • Physician Rating Scale for gait

  • 3‐dimensional gait analysis data (kinematics)

Notes Comments:
  1. The study authors state: "Three patients in the BoNT‐A group and five patients in the Cast group were unsuitable for the Vicon system because of age/height/cooperation constraints".


Source of funding: supported by The Royal Belfast Hospital for Sick Children, the Medical Research Council, the MITRE trust, the Canon Gribben Legacy, and the Helen C Young Trust Fund
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: 1 of 20 cards containing instructions for BoNT‐A or cast was drawn for each child (10 cards for each group)
Allocation concealment (selection bias) Low risk Comment: adequate allocation concealment. Instructions written in identical, sealed envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: no blinding of participants and personnel providing treatment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: the surgeon assessing the postintervention gait videotapes was blinded to the treatment received
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: gait analysis data were not available for 3 children in the BoNT‐A group and 5 children in the cast group, as described in the 'Notes' section above.
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