Corry 1997.
Methods | Double blind randomised controlled trial comparing BoNT‐A injections with injections of normal saline. Randomisation was restricted to ensure 7 patients in each group. One of 14 envelopes containing the instruction "placebo" or "botulinum" was drawn for each patient and opened by the non‐blind injector just before injection. Allocation concealment not clearly stated. Outcome assessors and participants were blinded. Follow up at 2 and 12 weeks. | |
Participants | 14 children (5 male, 9 female; mean age 9 years) (n=7 Treatment, n=7 Control) with a dynamic component to spasticity ‐ 12 hemiplegia, 1 quadriplegia, and 1 triplegia. Three had previous upper limb surgery. No dropouts reported. | |
Interventions | Treatment Group (BoNT‐A alone)
Refer to Table 14 Control (placebo) Intramuscular injection of saline. |
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Outcomes | Active ROM of MCP, wrist and elbow extension; thumb in palm position for both thumb extension and abduction; Ashworth scale for thumb, wrist, and elbow tone; wrist resonance frequency (tone); grasp and release of an empty film capsule scored using a modified Reddihough scale and the number of transfers of a coin. | |
Notes | The authors were contacted and generously provided assistance, however no additional data were available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |