Table 3 Schematic overview of the composition, roles and responsibilities, and meeting frequency of the working groups providing trial support

Trial steering group

Day-to-day management team, child neurologist, child orthopedic surgeon, experts in the field of (pediatric) rehabilitation

- Agreement on final protocol

- Reviewing study progress and if necessary agreeing on changes to the protocol

- Assistance in patient recruitment

- Data analysis and interpretation

- Reporting of trial results to relevant parties

- Advice on publicity and presentation of all aspects of the trial

Three times a year

Day-to-day management team

Principle investigator and main researchers

- Study planning and coordination (e.g., communication between involved parties)

- Budget administration

- Initial preparation and revisions of the study protocol and related documents

- Organization of meetings with the trial steering group

- Clinical trial registration (e.g., ClinicalTrials.gov)

- Trial conduct (e.g., scheduling therapy sessions, performance of eligibility screening, study logistics)

- Recording and reporting of adverse events

- Data quality assurance

- Provision of annual progress report to the Ethics Committee Research UZ/KU Leuven

Monthly meetings

Principal investigator

Senior professor at KU Leuven

- Supervise trial conduct

- Protect rights, safety and well-being of participants

- Responsible for data storage and preservation

/

Data management team

Main researchers

- Build trial specific database on REDCap platform

- Data entry and verification

Monthly meetings

Stakeholders

Physiotherapists working in private practices across Flanders and children and adolescents with unilateral cerebral palsy and their parents

- Advice on study protocol (e.g., therapy intensity, duration of therapy and assessment sessions)

- Discussions on strengths/weaknesses/opportunities/threats of this study

Occasional video-meetings