Study design
A quasi-randomized, waitlist-controlled, assessor-blinded trial with two groups was conducted. Both groups received an INRS treatment course and four weeks of routine home treatment but in reverse order. The experimental group underwent INRS treatment and, after that, continued home treatment for four weeks. The control group stayed on the waiting list for four weeks receiving routine home treatment after the first evaluation and then came for INRS treatment (Fig. Timeline of the interventions and assessment proceduresPatients who planned to receive treatment in the tertiary care facilities providing INRS treatment (International Clinic of Rehabilitation or Elita Rehabilitation Center) were considered potential participants. Candidates were selected according to defined inclusion criteria by reviewing their previously obtained medical documentation. The study coordinator remotely (via phone and e-mail) explained the study details to the family and child and re-checked the inclusion–exclusion criteria. If the child and parents were ready to participate and signed the informed consent form, they were randomly assigned to the experimental or control group by the study coordinator, that was not involved in the assessment or treatment processes.Group allocation was performed using quasi-randomization whereby participants were assigned to the experimental or control group in the order in which they enrolled in the study in the step of 3 (the first 3 participants were assigned to the experimental group, then the next 3 to the control group, then next 3 to the experimental and so on).All the participants were evaluated three times: at baseline -time T1, after the first period – time T2 (after INRS treatment for the experimental group and routine home treatment for the control group), and in the end – time T3 after groups switched treatments. Evaluations have been performed by certified and trained therapists blinded to group allocation. All data were forwarded to the supervisor on the same day. The study protocol was registered on ClinicalTrials.gov under the identifier: NCT04093180 on 17/09/2019.