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

Flett 1999.

Methods Method of randomisation: sequence generation not clearly described. Allocation carried out by the hospital pharmacy.
Blinding: participants and person administering treatment were aware of treatment allocation. Research clinicians were blinded to the intervention arms.
Intention‐to‐treat analysis: no
Loss of follow‐up: 2 dropouts from the BoNT‐A group ("one for social reasons, and the other at parental request because of the perceived need to treat differently by a combination of botulinum toxin A and fixed plaster treatment")
Unit of analysis: lower limb for local measures and likely child for global measures
Participants Place: 1 centre in Australia
Period of study: not described
Number assigned: 20
Number assessed: 18
  • 8 BoNT‐A group

  • 10 casts group


Inclusion criteria:
  • Ambulatory children with CP and lower limb spasticity, dynamic muscle tightness, equinovarus or equinovalgus of the foot, and unresponsive to other treatment modalities

  • Passive dorsiflexion of the ankle achievable

  • Aged 2 to 8 years


Exclusion criteria:
  • Previous surgery and previous phenol injection

  • Fixed contractures or severe athetoid movements

  • Leg‐length discrepancy > 5 cm

  • Significant muscle weakness of atrophy in the calf muscles

  • Children over 8 years of age


Age:
  • BoNT‐A group (mean/SD): 3.89/1.44 years

  • Casts group (mean/SD): 3.56/1.32 years


Gender:
  • BoNT‐A group: 5 males; 3 females

  • Casts group: 6 males; 4 females


Motor distribution:
  • BoNT‐A group: 6 diplegia; 1 quadriplegia; 1 hemiplegia; 0 triplegia

  • Casts group: 4 diplegia; 1 quadriplegia; 4 hemiplegia; 1 triplegia


GMFCS:
  • Not described. Likely all GMFCS I, II, and III

Interventions BoNT‐A group:
  • Single BoNT‐A injection (onabotulinumtoxinA) into the gastrocnemius (dose 4 to 8 U/kg) not exceeding 20 U per site

  • Night plasters for 8 weeks


Casts group:
  • Fixed plaster casts for 4 weeks (2 × 2 weeks)

  • Night plasters for 8 weeks

Outcomes Length of follow‐up:
  • Follow‐up of 6 months

  • Assessments at baseline, 2, 4, and 6 months


Primary outcomes:
  • Physician Rating Scale

  • Global Scoring Scale for Gait

  • Modified Ashworth Scale

  • Range of motion of the ankle

  • Gross Motor Function Measure

Notes Comments: none
Source of funding: Crippled Children’s Association Research and Development Fund
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: not clearly described
Allocation concealment (selection bias) Low risk Comment: central allocation
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: no blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: blinding of outcome assessors
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