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

Zhu 2016.

Methods Method of randomisation: random number table was used for randomisation
Blinding: no blinding
Intention‐to‐treat analysis: no
Loss of follow‐up: no
Unit of analysis: lower limb for local measures and child for global measures
Participants Place: 1 centre in China
Period of study: not described
Number assigned: 40
Number assessed: 40

  • 40 BoNT‐A group

  • 40 control group


Inclusion criteria:

  • Children with spastic CP

  • Aged 9 to 36 months

  • GMFCS levels II‐IV

  • Gastrocnemius spasticity (Tardieu Scale R2 to R1 ≥ 10°)

  • At least 6 months without BoNT‐A treatment

  • Family agreed with treatment and signed informed consent


Exclusion criteria:

  • Allergies, severe liver and kidney dysfunction

  • Presence of neuromuscular junction disorders

  • Infection at the injection site or other parts of the body

  • Use of drugs affecting the neuromuscular junction within 1 week

  • Severe joint fixed contractures


Age:

  • BoNT‐A group (mean (SD)): 20 (5) months

  • Control group (mean (SD)): 20 (5) months


Gender:

  • BoNT‐A group: 28 males; 12 females

  • Control group: 32 males; 8 females


Motor distribution:

  • BoNT‐A group: 21 diplegia; 8 hemiplegia; 11 quadriplegia

  • Control group: 21 diplegia; 9 hemiplegia; 10 quadriplegia


GMFCS

  • Not described. Presumably all GMFCS II, III, and IV based on the inclusion criteria
Interventions BoNT‐A group:

  • Single‐cycle BoNT‐A injections (onabotulinumtoxinA) 3 U/kg into gastrocnemius guided by ultrasound. Maximum dose 20 U per injected muscle

  • 4 courses of rehabilitation training


Control group:

  • 4 courses of rehabilitation training
Outcomes Length of follow‐up:

  • Follow‐up of 6 months

  • Assessments at baseline, 1, 2, 3, and 6 months


Primary outcomes:

  • Modified Tardieu Scale


Secondary outcomes:

  • Surface electromyography

  • Gross Motor Function Measure‐88

  • Adverse events
Notes Comments: none
Source of funding: funded by general science and technology project of Zhengzhou Science and Technology Bureau (153PKJGG164)
Conflict of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: random number table
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 High risk Comment: no blinding of outcome assessors
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no missing outcome data
Selective reporting (reporting bias) Low risk Comment: no selective reporting. Study protocol previously registered and available at www.chictr.org.cn (ChiCTR‐IPR‐15006318)
Other bias Low risk Comment: no other sources of bias