| Methods |
Prospective randomized, single‐blind, experimental trial. |
| Participants |
10 children aged 3 to 14 years with Charcot‐Marie‐Tooth disease type 1A. Pes cavus was defined weight bearing by a Foot Posture Index score between –12 and –1 (Redmond 2006) |
| Interventions |
One leg received intramuscular injections at six‐monthly intervals of botulinum toxin type‐A in the posterior tibialis and peroneus longus muscles, and one leg received no intervention. |
| Outcomes |
Primary outcome was radiographic alignment at 24‐months. Secondary outcomes were objective clinical measures of foot structure, ankle flexibility and strength. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
A simple randomization sequence was determined by coin‐toss |
| Allocation concealment? |
Low risk |
Central allocation by Paediatric Neurologist not involved in recruitment |
| Blinding?
Participant |
High risk |
Each child/parent was aware of the leg selection for treatment |
| Blinding?
Investigator |
High risk |
The injecting physician was aware of the leg selection for treatment |
| Blinding?
Assessor |
Low risk |
The principal investigator conducting all outcome measures was blinded to the injected leg |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
No missing data |
| Free of selective reporting? |
Low risk |
Protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way |
| Free of other bias? |
Low risk |
The study appears to be free of other sources of bias. Explicit inclusion criteria, no baseline differences |
