Assessment of outcomes
RECRUITMENT, BLIND
All children receive standard of care for their treatment procedure and complete four study visits: 1 to 2 weeks prior to treatment, and 7 weeks, 6 months, and 12 months after treatment. After the first study visit, participants are randomized to either the intervention or control study group. Participants are randomly assigned, in random blocks of 4 and 8, in a 3:1 ratio to either the intervention (n = 36) or control (n = 12, standard care but no intervention) study group. Standard care includes the monitoring of heart function and treatment recovery but does not include physiotherapy or any support for motor development or physical activity.The feasibility outcomes assessed address four aspects of study design:Participant recruitment (# of patients treated per month, randomization to control or intervention, clarity of inclusion/exclusion criteria, ability of healthcare professionals to facilitate pre-treatment recruitment, reasons for refusal/ineligibility),Data collection procedures (% of patients with completed pre-treatment data, # of days available prior to treatment for baseline data collection, % of parents able to complete child accelerometer wear for 7 days, % of control and intervention who complete all data sessions, frequency of missing data, study time and burden),Intervention delivery (% retention and follow up, % compliant with intervention and rate of adherence, intervention time and burden), andRequired resources (staff time required to identify/consent/follow patients, space available for baseline testing, kinesiologist time to create/support interventions).Preliminary efficacy data are collected from all study participants at or after each 1-hour study visit. The researcher conducting the study assessments is blind to study group allocation. The medical history of each participant is compiled from medical records (e.g., diagnosis, type and time of repair, length of hospital stay(s)). Parents complete four questionnaires: a) demographic questionnaire (age, gender, family income, parent education), b) an assessment of their child’s quality of life (Pediatric Quality of Life (PedsQL [At the end of each study visit, children are given a tri-axial Actigraph GT9X Link accelerometer to wear on a waistband under the child’s outer garments, over the right hip, in the mid axillary line [