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

Mall 2006.

Methods Method of randomisation: randomisation done using a predetermined list
Blinding: both participants and assessors blinded to the intervention
Intention‐to‐treat analysis: yes
Loss of follow‐up: 4 children lost to follow‐up
BoNT‐A group:
  • Missing value (n = 1)

  • Protocol violator (n = 1)

  • Unblinded participant (n = 1)


Placebo group:
  • Missing value (n = 1)


Unit of analysis: not described
Participants Place: 9 centres in Germany and 1 centre in Austria
Period of study: not described
Number assigned: 61
Number assessed: 57
  • 27 BoNT‐A group

  • 30 placebo group


Inclusion criteria:
  • Children with CP and bilateral adductor spasticity

  • Age from 18 months to 10 years

  • Migration percentage < 50%


Exclusion criteria:
  • Hip dislocation

  • Previous treatment with BoNT‐A within 9 months

  • Previous surgery in injected muscles


Age:
  • BoNT‐A group (mean/SD/range): 6.08/3.0/1.92 to 10.83 years

  • Placebo group (mean/SD/range): 5.75/2.17/2.33 to 10.0 years


Gender:
  • Both groups: 37 males; 24 females


Motor distribution:
  • BoNT‐A group: 22 leg‐dominant quadriplegia; 10 quadriplegia

  • Placebo group: 17 leg‐dominant quadriplegia; 11 quadriplegia


GMFCS:
  • BoNT‐A group: 1 level I; 3 level II; 12 level III; 12 level IV; 4 level V

  • Placebo group: 2 level I; 2 level II; 5 level III; 17 level IV; 2 level V

Interventions BoNT‐A group:
  • Single BoNT‐A injection (abobotulinumtoxinA) 30 IU/kg into adductors (2/3 total dose) and into the medial hamstrings (1/3 total dose)


Placebo group:
  • Injection of human albumin and lactose into adductors and the medial hamstrings

Outcomes Length of follow‐up:
  • Follow‐up of 3 months

  • Assessments at baseline, weeks 4 and 12


Primary outcome:
  • Knee‐knee distance


Secondary outcomes:
  • Hip abduction (range of movement)

  • Modified Ashworth Scale

  • Gross Motor Function Measure, total score and goal total score without aids and orthesis

  • Goal Attainment Scale

Notes Comments: none
Source of funding: not reported
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: randomisation was done using a predetermined list
Allocation concealment (selection bias) Low risk Quote: "The master list was kept confidential by the drug supplier"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: both participants and personnel were blinded to the intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: outcome assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: all predetermined outcomes were described in the results, but no means, SD, or P values were given for most of the non‐significant results. This was likely due to space restrictions in the journal.
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