Table 1 Design considerations. Considerations regarding the design of the study and the participants/children
Issue of consideration | Impact on study design |
|---|---|
Compliance by patients, families and practitioners for the recommended interdisciplinary interventions | Patients and familiesParents and the local team will receive the gait analysis report where the impairments are outlined and the recommendations are explained. |
PractitionersThe local team will be contacted and given the opportunity to ask questions about the report and recommendations. | |
Risk of noncompliance with intervention amongst practitioners who are responsible for healthcare for two or more participants. | Physical therapy First randomised patient will undergo randomisation as described. The remaining patients followed by the same physiotherapist will be given the same allocation. |
Orthopaedic surgery, spasticity management, orthotics Relatively few practitioners carry out these interventions; therefore it is not possible to take into account the risk of noncompliance with the intervention amongst practitioners. | |
Synchronisation of interventions | Gradually, it could be assumed that methods/knowledge/attention introduced by the IGA will influence the control group. This will be evaluated post-hoc via a comparison of interventions used in the control group in the first 6 months of the study with the interventions used in the last 6 months of the study. |