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

Çağlar 2019.

Methods Method of randomisation: block randomisation, no further details given
Blinding: all participants and personnel blinded to the intervention
Intention‐to‐treat analysis: not described
Loss of follow‐up: 0
Unit of analysis: not described clearly, but likely each child was the unit of analysis
Participants Place: 1 centre in Turkey
Period of study: not described
Number assigned: 30
Number assessed: 30
  • 15 BoNT‐A group

  • 15 control group


Inclusion criteria:
  • Spastic CP

  • Aged 2 to 15 years

  • Lower extremity spasticity with MAS > 2

  • No previous spasticity treatment within the last 6 months


Exclusion criteria:
  • Fixed contractures, advanced atrophy, subluxation of the affected extremity

  • Previous BoNT‐A and phenol injections, intrathecal baclofen pump therapy, or surgical treatment of spasticity

  • History of allergy and hypersensitivity against drugs to be used

  • Haematoma, infection, or skin lesion in the injection site

  • Use of aminoglycoside antibiotics

  • Having mental retardation


Age:
  • BoNT‐A group (mean (SD)): 9.01 (2.47)

  • Control group (mean (SD)): 9.46 (2.89)


Gender:
  • BoNT‐A group: 37.5% males; 56.3% females

  • Placebo group: 46.7% males; 53.3% females


Motor distribution:
  • Not described


GMFCS:
  • Not described

Interventions BoNT‐A group:
  • Single BoNT‐A (onabotulinumtoxinA) injection administered at 3 IU/kg per muscle, with total dose not exceeding 300 IU. The lower extremity muscles (gastrocnemius, soleus, tibialis anterior and posterior, quadriceps, hip adductors, and hamstrings muscles) with a Modified Ashworth Scale score > 2 underwent treatment.

  • Children used a resting splint and underwent a rehabilitation protocol with 5 sessions of physical therapy per week (20 sessions), followed by the exercises being maintained at home


Control group:
  • The same rehabilitation protocol as above

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

  • Assessments at baseline, 4 and 12 weeks


Primary outcomes:
  • Modified Ashworth Scale


Secondary outcomes:
  • Goal Attainment Scale

  • Selective motor control test

  • GMFCS

Notes Comments:
  1. The GMFCS level was used as an outcome measure, rather than being used to describe the children's baseline characteristics.


Source of funding: the study authors report that this study received no outside funding
Conflict of interest: the study authors report no conflict of interest
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: the children were divided into the BoNT‐A and control groups by block randomisation (sequences of AB and BA)
Allocation concealment (selection bias) High risk Comment: no allocation concealment
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: participants were not blinded due to the nature of the interventions. All rehabilitation protocols were performed by blinded physiotherapists.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: blinding of outcome assessment was not clearly described
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: data were not presented for all muscle groups. It is unclear to which muscles the provided MAS and Tardieu Scale data refer.
Selective reporting (reporting bias) Unclear risk Comment: study protocol not available. Most of the relevant outcomes were reported.
Other bias Low risk Comment: no other sources of bias identified

AFO: ankle foot orthosis; BoNT‐A: botulinum toxin type A; CP: cerebral palsy; DQ/IQ: Development Quotient/Intelligence Quotient; GMFCS: Gross Motor Function Classification System; GMFM: Gross Motor Function Measure; IU: international units; MAS: Modified Ashworth Scale; MP: Migration percentage; PEDI: Pediatric Evaluation of Disability Inventory; PT: physical therapy; SD: standard deviation;SE: standard error; SWASH: standing, walking and sitting hip orthosis; U: units.