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 |
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Participants |
Place: 1 centre in Turkey Period of study: not described Number assigned: 30 Number assessed: 30
Inclusion criteria:
Exclusion criteria:
Age:
Gender:
Motor distribution:
GMFCS:
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Interventions |
BoNT‐A group:
Control group:
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Outcomes |
Length of follow‐up:
Primary outcomes:
Secondary outcomes:
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Notes |
Comments:
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 |
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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.