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

Steenbeek 2005.

Methods Method of randomisation: not described
Blinding: no blinding
Intention‐to‐treat analysis: no
Loss of follow‐up: no
Unit of analysis: child
Participants Place: 1 centre in the Netherlands
Period of study: not described
Number assigned: 11
Number assessed: 11
  • 5 group A

  • 6 group B


Inclusion criteria:
  • Children with CP

  • Disabling spasticity of the lower extremity

  • Knowledge of the Dutch language


Exclusion criteria:
  • Not described


Age:
  • All groups (mean/range): 5.0/3 to 12 years


Gender:
  • Not described


Motor distribution:
  • All groups: 6 diplegia; 5 hemiplegia


GMFCS:
  • All groups: 4 level I; 3 level II; 3 level III; 1 level IV; 0 level V

Interventions Intervention phase:
  • Single‐cycle BoNT‐A injections (onabotulinumtoxinA) 4 to 6 U/kg/muscle group. Maximum dose of 50 U per injection site. Multilevel injections in 5 children and single‐level injections in 6 children

  • Regular physical therapy and occupational therapy


Baseline phase:
  • Regular physical therapy and occupational therapy

Outcomes Length of follow‐up:
  • Follow‐up of 14 weeks

  • Group A: baseline phase 8 weeks and treatment phase 6 weeks

  • Group B: baseline phase 6 weeks and treatment phase 8 weeks

  • Weekly assessments for both groups


Primary outcome:
  • Goal Attainment Scaling (blinded video scoring)


Secondary outcomes:
  • Goal Attainment Scaling (non‐blinded measure by the treating physiotherapist)

  • Modified Ashworth Scale

Notes Comments:
  1. Randomised multiple baseline/treatment phase trial design. All children received the intervention with different control and treatment phases.


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) High risk Comment: no allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: no blinding of participants and personnel
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: outcome assessors blinded for the primary outcomes
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 Unclear risk Comment: randomised, multiple baseline/treatment phase trial design may be a source of bias. All children received the intervention with 2 different control and treatment phases.