Summary of findings 6. BoNT‐A compared to placebo or sham in the treatment of lower limb spasticity in children with cerebral palsy: long‐term results.
| BoNT‐A compared to placebo or sham in the treatment of lower limb spasticity in children with cerebral palsy: long‐term results | ||||||
| Patient or population: children with CP Setting: long‐term follow‐up (> 24 weeks) Intervention: BoNT‐A injections into the lower limb muscles Comparison: placebo or sham injections | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with placebo or sham | Risk with BoNT‐A | |||||
| Instrumented gait analysis (kinematics) (not measured) | ‐ | ‐ | ‐ | ‐ | ‐ | Not measured in any trial |
| Observational gait analysis (not measured) | ‐ | ‐ | ‐ | ‐ | ‐ | Not measured in any trial |
| Function Assessed with: various scales (COPM performance, GMFM total scores) Follow‐up: range 6 to 24 months | ‐ | The SMD in the intervention groups was 0.07 SD lower (0.48 lower to 0.35 higher). | ‐ | 91 (2 RCTs) | ⊕⊕⊕⊝ Moderatea | No difference between groups. Rule of thumb to interpret the magnitude of effect for the SMD: 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988). |
| Range of motion (passive ankle dorsiflexion) Assessed with: goniometry (degrees) Follow‐up: range 6 to 24 months | The mean change in passive ankle dorsiflexion in the control group was −0.30 degrees (changes from baseline). | The mean change in passive ankle dorsiflexion in the intervention group was0.20 degrees higher (4.88 lower to 5.28 higher). | ‐ | 40 (1 RCT) | ⊕⊕⊕⊝ Moderateb | No difference between groups. Data were reported as changes from baseline. |
| Satisfaction Assessed with: COPM satisfaction Follow‐up: range 6 to 24 months | The mean change in the satisfaction score in the control group was 1.70 (changes from baseline). | The mean change in the satisfaction score in the intervention group was 0.10 higher (1.27 lower to 1.47 higher). | ‐ | 33 (1 RCT) | ⊕⊕⊕⊝ Moderateb | No difference between groups. Data were reported as changes from baseline. |
| Spasticity (ankle plantarflexors) Assessed with: MAS Follow‐up: range 6 to 24 months | The mean change in the ankle plantarflexors score in the control group was 0.40 (changes from baseline). | The mean change in the ankle plantarflexors score in the intervention group was 0.10 higher (0.58 lower to 0.78 higher). | ‐ | 42 (1 RCT) | ⊕⊕⊕⊝ Moderateb | No difference between groups. Data were reported as changes from baseline. |
| Adverse events | ‐ | ‐ | ‐ | ‐ | ‐ | See Table 4 |
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BoNT‐A: botulinum toxin type A; CI: confidence interval; COPM: Canadian Occupational Performance Measure; CP: cerebral palsy; GMFM: Gross Motor Function Measure; MAS: Modified Ashworth Scale; RCT: randomised controlled trial; SD: standard deviation; SMD: standardised mean difference. | ||||||
| GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded one level for imprecision due to the small sample size. bDowngraded one level for imprecision, as this outcome was reported by a single study with a relatively small sample size.