A double blind randomised controlled trial, assessing the effectiveness of the EBP training intervention, compared with a waitlist control, will be conducted.
In summary, a multi-centre randomised controlled trial that compares the clinical effectiveness of a combination of manual therapy and exercise therapy, exercise therapy only and a waiting-list control will be conducted.
Two RCTs with an identical sham control will be conducted to evaluate the efficacy of AOT compared with standard TOT in: (1) TDIs with a gestational age between 38 and 41 weeks at the time of recruitment (n = 40); and (2) infants with asymmetric brain lesions aged 0 9 post-term weeks at the time of recruitment (n = 32).
At each time point t (t = 1, 2, …, T), one of the following three control options will be conducted: Control 0 (i.e. no control), Control 1 and Control 2, represented by u0, u1 and u2.
More specifically, the superiority hypothesis, H1, involves two formal comparisons (i.e., IBET vs. WL control, and, separately, standard PT vs. WL control); each will be conducted at the two-sided.025 significance level.
A three-group randomized controlled trial will be conducted to study the effects of both versions of the intervention compared to a control group that will receive generic information about fruit, vegetables, high-energy snacks and fat.
